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Data Management Best Practices for Hospitals and Medical Facilities

Implementing accurate data management systems is imperative to ensure the efficient storage and transfer of patient information. Data management best practices also improve the confidentiality, reliability and comprehensiveness of this information.

To reap the benefits of exceptional data governance, hospitals and medical facilities must work together to better manage, organize, protect and transfer information between patients and providers. Here are a few key ways medical institutions can best practice hospital data management.

1. Use Technology

Effective use of technology is essential to proper data management. With tools such as electronic health records, health care customer relationship management and revenue cycle management, the health sector can organize and manage the influx and distribution of information.

More than 90% of U.S. hospitals are implementing EHRs, since they’re often the most accessible. This widespread adoption fosters the creation of more unified data management systems. However, health providers still generate at least 50% of patient records outside EHRs.

Facilities collect patient information from a variety of sources, including paper forms, data imaging, transcriptions, nurse notes and remote monitoring systems. To unlock the full value and potential of this flood of information, they must first transfer it into a widely used system like an EHR. Thus, providers must both collect and sort through data and organize it within this widely used system to apply the findings.

2. Standardize Data

Among the challenges for the broad adoption of EHR is ensuring consistent electronic data that providers can share between systems.

Because data sets come from a variety of machines, health organizations and locations across the country, various clinical data domains may represent them differently. As a result, physicians are more likely to misinterpret medical data andย make errors in patient care.ย Therefore, standards for capturing, defining and transmitting data are vital to interoperability.

Over the years, dedicated standards development organizations, government agencies and other specialists have developed a host of data standards for health care. While this is a step in the right direction, it also presents competing and redundant measures that don’t promote consistent or comprehensive data.

Health information managementย teams continue to work to reconcile these standards. But, in the meantime,ย hospitals can focus on achieving standardized data within their facilities by implementing a single shared data management system.

3. Enable Seamless Information Exchangeย 

As technical data stewards and health information management teams continue to standardize data input, health information exchange professionals work to streamline information transfer. Proper data management is crucial for enhancing patient care and reducing errors in medical records. In this context, services like trauma registrar abstraction services play a vital role. They help ensure that trauma-related data is accurately recorded and maintained, feeding quality information into health data systems. Although HIEs currently operate in an app-centric format, they’re beginning to transition to a more patient-centric view. This shift will facilitate the seamless exchange of clinical information to stakeholders, health providers and patients.

For instance,ย more than 90% of patient-generated data comes from medical imaging. However, these images are challenging to share electronically because they’re often spread across different department systems. HIEs, therefore, must connect imaging content across the care continuum. One way to accomplish this is by implementing vendor-neutral archives, which provide interoperability among departments and allow harmonious data and imaging exchange.

4. Form a Comprehensive Viewย 

By creating more standardized data and facilitating its exchange, medical institutions improve the information’s reliability, thus forming a comprehensive 360-degree view of both providers and patients. This complete picture helps organizations understand where providers practice and what patients they see.

Therefore, it’s essential to link information from various profiles โ€” including name, address and Medicare and Medicaid number โ€” to the same provider. This practice ensures no one overlooks pieces of information and data is consistent between profiles.

Still, many health plans find more than half the patients’ contact informationย is out of date. Since the same patient may have inaccurate or old details stored in their name at numerous health care institutions, a consolidated format linking back to them is crucial.

For example, if a physician overlooks a vital piece of information, like an allergy, this could result in medical malpractice and adverse reactions in the patient. Thus, it’s best to prompt patients to provide updated data whenever possible.

5. Protect Sensitive Dataย ย 

Since systems store this medical information electronically, it’s susceptible to security breaches. Data breaches compromise sensitive data and can be very costly for providers.

In 2011 and 2012, 94% of health care organizations suffered at least one data breach, and 45% experienced more than five breaches in the same span. Therefore, hospitals and medical facilities must be more diligent in protecting electronic data and management systems.

By following regulations such as those established by the Health Insurance Portability and Accountability Act, health care providers can safeguard the security and privacy of protected health information.

Appropriate data management practices include setting policies to ensure this protection, such as a mobile device policy, which governs what data users can store on apps and mobile gadgets. Organizations should also secure wireless networks, encrypt portable devices and educate staff members on what constitutes a HIPAA violation.

The Final Goalย 

There are many benefits to proper health care data management practices. From creating a more streamlined information exchange to enhancing patient service and security, data management supports both providers and patients.

Of course, the final goal of any health data management system is to ensure the quality and interoperability of information. In turn, this data can provide critical insights, allowing medical professionals to take action. And, in doing so, they keep patients engaged, satisfied and healthy.

Stance Healthcare Frontier Collection Wins Nightingale Gold Award

Stance Healthcare Frontier Collection Wins Nightingale Gold Award

Stance Healthcare, a furniture designer and manufacturer specializing in Behavioral Health spaces, has received the 2019 Nightingale Gold Award in the category of furniture collections. The award was officially announced at Healthcare Design’s HCD Expo and Conference earlier this fall.

The winning Frontier line, a rotationally-molded collection for Behavioral Health consisting of a bed and bedside cabinet, showcases the companyโ€™s signature approach to designing products that prioritize safety and durability, while offering comfort and a residential feel. The easy-to-clean collection is constructed with high-impact polyethylene, continuously molded for maximum durability, and features rounded corners and edges, providing a safe environment for patients. The bed also features an innovative system that supports fluid removal.

โ€œUnlike any other Behavioral Health patient room product in the industry, The Frontier Collection is unique because of the way it can improve the patient experience,” said Suzanne Fawley, Stance Healthcareโ€™s Behavioral Health interior designer who developed the line with the company. โ€œBy designing for durability, functionality, and comfort, we really tried to anticipate the needs of patients, caregivers, and visitors.”

Unique to the collection is the flip-style bedside cabinet for preferred configuration, providing designers with increased flexibility and highly usable space for patients to keep their personal belongings. The Frontier bed and bedside cabinet have more residential appeal than other rotationally-molded products on the market. Specifically, the floor mount system for the bed was developed to have minimal impact on the overall aesthetics of the product, helping the patient feel at ease in their environment.

โ€œWe created this collection in response to the growing demand for Behavioral Health products with residential appeal,โ€ said Carl Kennedy, Stance Healthcareโ€™s president. โ€œWe are overjoyed that our design efforts to improve the quality of life for patients, while maintaining the design specifications required for intensive use environments, was recognized by the healthcare design industry with the Nightingale Gold Award.โ€

The honor is the companyโ€™s second Gold Nightingale win and marks the third consecutive year of notable design industry awards for Stance, who is solidifying its niche as innovators in the rapidly-growing Behavioral Health space, particularly in the U.S. The 2019 Nightingale win is preceded by a 2018 win for Best Large Booth at top commercial design conference NeoCon, and a 2017 Nightingale Gold Award for Stanceโ€™s Resilia drum table collection.

Additional rotationally-molded pieces of the collection, including a desk and wall-mount shelf, will be available in early 2020. More coverage of the 2019 Nightingale winning products, including the Frontier collection, will be published in January issue of Healthcare Design.

About Stance Healthcare

Founded in 2006, Stance Healthcare manufactures furniture for healing environments, with a particular focus on hospitals and behavioral health facilities. Stance Healthcare has a reputation for providing high-quality products that meet the everevolving demands in the areas of design, comfort, safety, durability, renewability, infection control and environmental sustainability. With a strong understanding of patient-centered design, Stance Healthcare is committed to providing innovative furniture solutions that support the healing process. Please visit www.stancehealthcare.com for the latest news and in-depth information on Stance Healthcare

Medical Fair China Post Show Report

Medical Fair China Post Show Report

The demand for medical technology in China remains enormous and ranges from high-end magnetic resonance devices all the way to prostheses and surgical instruments. Investments are being made in the modernisation of the healthcare system, in privatisation and increasingly in geriatric care facilities.

Click here to download the Report

Click here to see the Visitior structure of the MFC 2019

 

 

What Are the Benefits of CBD?

CBD

More than 60 percent of CBD users perceive this as a concern, according to a survey of 5,000 people, conducted by the Brightfield Group. Does it help?

The CBD industry is booming. According to conservative forecasts, by 2025, it will reach $16 billion in the United States. Plant extract is already being added to cheeseburgers, toothpicks, and breathing sprays. Chronic pain, insomnia, and depression follow behind. For example, Kim Kardashian West turned to the product when she โ€œwent crazyโ€ due to her fourth child’s birth. Professional golfer Bubba Watson is sleeping with him. And Martha Stewart, the French bulldog, also takes part.

The vape market offers many products. This oil’s potential therapeutic properties are the primary reason why more people are purchasing cbd pods (additional info) and cartridges.

What is Cannabidiol

Cannabidiol, or CBD, is a lesser-known descendant of the cannabis sativa plant, his better-known brother. With roots in Central Asia, it is believed that the plant was first used for medicinal purposes – or for rituals – around 750 BC. E., Although there are other estimates.

Cannabidiol and THC are composed of two more than 100 types of cannabinoids. THC is psychoactive, and CBD may or may not be the subject of controversy. THC may increase anxiety; it is not clear what effect the CBD has on its decline. CBD is being studied to help those who are recovering.

Cannabis, containing 0.3% or less of THC, is hemp. Although last year’s farm bill legalized marijuana under federal law, it also retained the Food and Drug Administration’s oversight for hemp products.

Vaping offers many different products, such as CBD oil cartridge and CBD juul pods. Many hemp users use a CBD vape cartridge.

What are the claims?

CBD is touted as a cure for anxiety, depression, and post-traumatic stress disorder. It is also sold to promote sleep. Part of the CBD’s popularity is that it claims to be โ€œnot psychoactive,โ€ and that consumers can benefit from the plant without high (or midnight snacks).

Just as hemp seedlings sprout in the United States, so is marketing. Apparently, from oils and nasal sprays to candy and candles, it seems that there is no place to be too sacred for the CBD. โ€œThis monster has taken over the room,โ€ said Dr. Brad Ingram, an assistant professor of pediatrics at the University of Mississippi Medical Center, about all CBD cases in the wild. He leads clinical trials for the introduction of CBD in children and adolescents with drug-resistant epilepsy.

CBD working?

โ€œThis is promising in many different therapeutic areas because it is relatively safe,โ€ said James MacKillop, one of the directors of the Center for Cannabis Research in Medicine at Michael G. DeGroote at McMaster University in Hamilton, Ontario.

Last year, F.D.A. Epidiolex-approved, purified CBD extract, for treating rare convulsive disorders in patients 2 years of age and older after three randomized, double-blind, and placebo-controlled clinical trials with 516 patients, which showed that the drug taken with other drugs helped reduce seizures. These studies are the gold standard in medicine in which participants share randomly, and neither the subject nor the researcher knows which group is taking a placebo or medicine.

Although it is hoped that other diseases can be treated with plant extract, Epidiolex remains the only CBD approved F.D.A. Most of the research on cannabidiol has been done on animals. Its popularity is now ahead of science.

Does CBD help anxiety and PTSD?

For students with general social anxiety, a four-minute conversation with minimal preparation time can be exhausting. However, a small experiment in the journal Neuropsychopharmacology found that CBD reduces nervousness and cognitive impairment in patients with social anxiety when modeling public speaking.

However, a double-blind study showed that healthy volunteers who received CBD had few emotional responses to unpleasant images or words compared to the placebo group. Harriet de Wit, the co-author of the study and professor at the Department of Psychiatry and Behavioral Neurology at the University of Chicago, speaks of the impossibility of changing patients’ responses to stimuli using sedative drugs.

Many soldiers return home, pursued by war and PTSD, and often shun specific actions, places, or people associated with their traumatic events. The Department of Veterans Affairs is funding its first CBD study, combining it with psychotherapy.

Does CBD help sleep and depression?

In the small hours of the night stuck watching videos of puppies? CBD can be a promising sleep remedy; According to Mr. MacKillop, co-author of the Cannabinoid and Sleep Survey, one of the side effects of the Epidiolex trials for the treatment of epilepsy was drowsiness. He said that looking for new treatments for sleep might be the key.

But he warns that side effects could occur due to interactions with other medicines that the children took to control seizures. So far, there has not been a randomized, placebo-controlled, double-blind study.

Conforming to a recent chart review of 72 psychiatric patients treated with CBD found that anxiety improved, but not sleep. โ€œOverall, we did not find it to be a useful cure for sleep,โ€ said Dr. Scott Shannon, associate professor of psychiatry at the University of Colorado, Denver, and lead author of the review at The Permanente Journal.

According to a review of the Journal of Chemical Neuroanatomy, rodents adapted better to stressful conditions and showed less depressive behavior after taking CBD. One of the authors of the new review, Sรขmia Joca, a researcher at the Aarhus Institute for Advanced Study in Denmark and associate professor at the University of Sรฃo Paulo in Brazil, said that CBD’s action is much faster than the effect of antidepressants. These studies have increased demand for the best CBD vape cartridge.

Of course, it is difficult to detect depression in animals, but the studies examined by Ms. Joka and her colleagues showed that in models of chronic stress exposure, mice and rats treated with CBD were more stable.

Since there are no clinical trials in humans, CBD’s effect on depression is a hypothesis, not evidence-based treatment.

Is CBD harmful?

Marcel Bonn-Miller , associate professor of medicine at the University of Pennsylvania at Perelman says that pure CBD is pretty safe. Side effects in the Epidiolex study included diarrhea, drowsiness, fatigue, weakness, rash, decreased appetite, and increased levels of liver enzymes. Also, the safe amount to consume per day or even during pregnancy is still not known.

Recently F.D.A. directed by Curaleaf Inc. A warning letter about their โ€œunsubstantiated claimsโ€ that plant extract treats various conditions from anxiety and depression in pets to cancer and opioids withdrawal.

Dr. Smita Das, chair of the Psychiatric Association Board of Psychiatry at the American Psychiatric Association,Dr. Smita Das, chair of the Psychiatric Association Board of Psychiatry at the American Psychiatric Association, does not recommend using it as a medicine. When patients turn to these unsuccessful products, she is worried that they may delay the request for proper psychiatric care: โ€œIโ€™m concerned about how exposure to CBD products can lead someone to continue to use cannabis products.โ€

Some CBD products may contain unwanted surprises. Commonwealth Virginia Forensic Toxicologists examined nine e-liquids touted as 100% natural CBD extracts. They found one with dextromethorphan, or DXM, used in over-the-counter cough medicines and was considered addictive when abused. According to a study last year at Forensic Science International, four with synthetic cannabinoids is sometimes called Spice, which can cause anxiety, psychosis, tachycardia, and death.

A previous study showed that less than a third of the 84 products examined contained the amount of CBD on the labels. Some CBD users also failed drug tests when the product contained more THC than indicated.

The American Association of Poison Control Centers record 1090 cases. More than a third of patients received medical care, 46 were hospitalized in the intensive care unit, possibly due to exposure to other products or drug interactions. Also, concerns about 318 animals were poured into the American Society for the Prevention of Cruelty to Animals at the Animal Poison Control Center.

The bottom line

So, the researchers have conflicting views on the benefits of CBD products. But most scientists emphasize the advantage of CBD. CBD’s potential health benefits are the reasons why a person can invest in a CBD prefilled cartridge and start taking it.

Jeff Herzfeld Brings Pharmaceutical Expertise to OCN ConnectedCare ERxDirect Team

Jeff Herzfeld Brings Pharmaceutical Expertise to OCN ConnectedCare ERxDirect Team

OCN ConnectedCare (OCN CC) announces that Jeff Herzfeld, a leader in the pharmaceutical field, has joined the team in an advisory role. Herzfeld will help shape the future of OCN CCโ€™s ERxDirect, which is revolutionizing pharmacy care by aggregating the power of community pharmacy and expanding the role of pharmacists in care management.

โ€œJeff Herzfeld is pharmacist leader and his involvement with ERxDirect at a senior level provides the insights of best-in-class pharmaceutical distribution and brand and generic manufacturing,โ€ said OCN CC Chief Strategy Officer Richard Scholz, RPh. โ€œJeff is an excellent fit for ERxDirect as we continue to revolutionize direct pharmacy procurement, distribution, and expanded care delivery where healthcare consumers work and live.โ€

ERxDirect is working to empower community pharmacies, providing a platform that enables growth and improves performance. ERxDirect works with independent pharmacies to improve care, lower costs and change perceptions of pharmaceuticals by providing personalized, local care through an expanding network of connected providers.

Herzfeld is the managing director of CLX, LLC, an independent consulting and advisory firm that works with healthcare and life-sciences companies. Their clients include pharmaceutical, biologics and private healthcare businesses. Prior to his work with CLX, Herzfeld held executive leadership roles for more than 25 years at Teva Pharmaceuticals, McKesson Corporation and Prescription Solutions, and began his career as a hospital pharmacist.

โ€œIโ€™m a longtime community pharmacy advocate, and my career has provided me the opportunity to work as an executive in a variety of different payer, pharmacy and pharmaceutical companies,โ€ Herzfeld said. โ€œI bring these experiences to ERxDirect as a thought leader in providing new, market-based solutions to the challenges faced by employers, pharmacies and patients as they work to solve issues of access and costs.โ€

OCN CC is an organization of business leaders, innovators, clinicians, pharmacists, scientists, engineers and healthcare consumers who believe itโ€™s possible to create a better consumer model for efficient access to quality care.

With Herzfeldโ€™s background in pharmacy and specialized insights into pharmaceutical development, his expertise is a perfect fit in the OCN CC team.

โ€œOCN CC is a seasoned team of professionals who see the potential of bringing together a variety of services,โ€ Herzfeld said. โ€œTogether, we can offer employers, patients and community pharmacies new solutions to improve the quality of care and provide greater cost transparency.โ€

About OCN ConnectedCare:

OCN CC is a leading managed health organization in the United States that provides healthcare solutions for employers and business opportunities for providers that are part of the companyโ€™s Health In Motion Network.

OCN CCโ€™s leadership has experience driving change and aggregating efforts toward innovation. Using their experience in virtual heath, OCN CC organizes market forces and delivery models to help shape the future of pharmacy and on-demand primary care, with the ultimate goal of improving patient care and provider-patient relationships.

LG Introduces Enhanced Display Devices for Medical Environments

LG Introduces Enhanced Display Devices for Medical Environments

LG Electronics Business Solutions is introducing larger, higher-resolution radiology and surgical monitors designed to offer hospitals and clinics improved work efficiency, advanced performance, expanded screen real estate and clean, minimalist designs. Demonstrated this week at RSNA 2019, the annual meeting of the Radiological Society of North America, the three new LG medical displays further expand the companyโ€™s diverse healthcare portfolio.

LG31.5-inch 8MP Radiology Monitor
LGโ€™s new 8-megapixel radiology monitor (model 32HL512D โ€“ FDA 510k Class II approval is pending) has a larger screen than its 27-inch predecessor and employs LG Nano Cell IPS display technology for image quality optimized for accurate reviews. While reducing unwanted light wavelengths, the Nano Cell IPS display enhances color purity to reproduce precise images that can be clearly seen from almost any vantage point.

This 31.5-inch 8MP monitor is lightweight and cost-effective, while being designed to deliver excellent image quality. It features out-of-the-box DICOM calibrated to ACR-AAPM-SIIM guidelines. With two DisplayPort video inputs, this monitor can be operated as two 4MP screens or as a single 8MP screen.

LG 31.5-inch 4K Surgical Monitor
LGโ€™s new 4K surgical monitor (model 32HL710S) features a large ultra-high-definition display that leverages LGโ€™s innovative technologies to provide highly-detailed images, greater ease of use, and reliability necessary for the O.R.

This monitor is engineered to provide low latency from video source to display. Its backlight brightness monitoring and control produce consistent flicker-free video. Model 32HL710Scan be used with a wide variety of endoscopy cameras to provide remarkably smooth and accurate up-scaling of Full-HD video.

The monitor also supports high dynamic range (HDR 10) content, delivering impressive contrast and colors when connected to an endoscope camera or other compatible devices. The advanced HDR 10 video format gives medical professionals a clear picture thatโ€™s easy to see and interpret.

LGโ€™s surgical monitor has 4PBP and PIP modes as well as multiple video input ports to display visual information from several devices simultaneously. This enhances work efficiency by making it possible to view a comprehensive range of data on a single screen. For improved flexibility, the 32HL710S provides the Mirror and Rotate functions. It also features easily- cleanable protective glass and has lightweight sleek design with a magnetic cover for precision cable management.

LG 24-inch Health Care All-in-One Thin Client
LGโ€™s first cloud device for the healthcare market, model 24CK560N is the companyโ€™s user-friendly solution designed to improve workflow for busy hospital environments. A complete product in its own right, the 24CK560Nfeatures a DisplayPort video output for connection of second monitor. Its IPS panel produces vibrant images with consistent colors and contrast from any viewing angle, meaning groups can gather around and clearly see any content on screen.

LGโ€™s Thin Client24CK560N can be quickly repositioned according to the userโ€™s needs with swivel-, pivot- and height adjustability. Whatโ€™s more, the all-in-one system represents a space-efficient replacement for existing PC and monitor setups, freeing up desk space and helping to create a less cluttered environment.

The product also been carefully designed to support the high level of hygiene required in medical facilities. Its white cabinet makes it easy for users or contracted cleaners to see and remove any dust or other foreign substances. Its fan-less design ensures a quiet performance that wonโ€™t distract users or patients.

The cloud device can be attached to a medical cart for maximum portability, letting staff securely log in and access information and resources from anywhere in the hospital. Model 24CK560N complies with a number of medical standards (IEC6060, CE MDD and FDA Class I), assuring suitability for healthcare settings.

LGโ€™s new monitors are featured in the LG Business Solutions booth, #2565 (South Hall, Level 3) in the McCormick Place Convention Center. RSNA 2019 runs through Dec. 7.

About LG Business Solutions USA
The LG Electronics USA Business Solutions division serves commercial display customers in the U.S. health care, lodging and hospitality, digital signage, systems integration, education, government and industrial markets. Based in Lincolnshire, Ill., with its dedicated engineering and customer support team, LG Business Solutions delivers business-to-business technology solutions tailored to various business environments. LG Electronics USA Inc.,based in Englewood Cliffs, N.J., is the North American subsidiary of LG Electronics Inc., a $55 billion global innovator in technology and manufacturing. LG is a 2019 ENERGY STARยฎ Partner of the Year-Sustained Excellence. www.LGSolutions.com

Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

Tandem Diabetes Care, a leading insulin delivery and diabetes technology company,announced U.S. FDA clearance of the t:slim X2โ„ข insulin pump with Control-IQโ„ข technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL)1, and the first system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.

The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no fingersticks for calibration or diabetes treatment decisions.2,3,4 Control-IQ technology for the t:slim X2 insulin pump is the first automated insulin dosing software in a new interoperable automated glycemic controller category that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the third category classified by the FDA for the interoperability of devices as a complete automated insulin dosing (AID) system.

All in-warranty t:slim X2 pump users in the United States will have the option to add the new feature free of charge via remote software update.5 The update is expected to be available by the end of January 2020, and new pumps with Control-IQ technology will begin shipping to customers in the same timeframe. The Company will continue to offer the t:slim X2 pump with Basal-IQยฎ predictive low glucose suspend technology as an option for people who prefer a system designed specifically to help prevent lows.

The t:slim X2 insulin pump with Control-IQ technology uses CGM values, in conjunction with other variables such as insulin on board, to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly. If glucose values are predicted to drop below 112.5 mg/dL, basal insulin delivery is reduced, and when predicted to be below 70 mg/dL, basal insulin delivery is stopped. If glucose values are predicted to be above 160 mg/dL in the next 30 minutes, basal insulin will be increased. If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL, and delivers 60 percent of that value up to once an hour as needed. Control-IQ technology also offers optional settings for sleep and exercise that will change the treatment values to better match the different physiologic needs during these activities.

With the interoperable automated glycemic controller designation, the FDA establishes a new device class which includes special controls outlining requirements for this and future submissions in this category, as well as describes the reliability, device interoperability, cybersecurity, and clinical relevance data required to demonstrate acceptable performance. The t:slim X2 insulin pump was also the first to receive an ACE infusion pump classification in February 2019, and the first insulin pump designated as compatible with iCGM devices in June 2018.

โ€œNot only do new closed-loop systems need to be effective at improving glycemic control, they must also be easy to understand and use so patients can experience the full benefits of the technology. The t:slim X2 insulin pump with Control-IQ technology successfully achieved both objectives in the clinical studies,โ€ said Boris Kovatchev, PhD, Director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the International Diabetes Closed Loop (iDCL) trials. โ€œWe are very proud of the extensive academic research that went into this effort, and we are thrilled to see this work has translated into an FDA-cleared device for clinical use so that more people can experience the benefits of this technology.โ€

โ€œWith this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world,โ€ said John Sheridan, president and CEO of Tandem Diabetes Care. โ€œThis is a testament to our commitment to improving the lives of people with diabetes by offering simple-to-use products that deliver superior performance.โ€

โ€œThe approval of the Control-IQ system with Dexcom G6 CGM brings together two incredible products to deliver a powerful automated insulin dosing solution for people with diabetes,โ€ said Kevin Sayer, president and CEO of Dexcom. โ€œSensor accuracy is a critical component for automated insulin dosing, and we are excited that Dexcom G6 users can benefit from our collaborative effort to integrate this advanced hybrid closed loop system.โ€

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. The t:slim X2 pump is capable of remote feature updates using a personal computer, and is the only automated insulin dosing device approved for children as young as 6 years old. Tandem is based in San Diego, California.

Clinerion becomes EHDEN certified, supporting the building of a federated health data network in Europe.

Clinerion becomes EHDEN certified, supporting the building of a federated health data network in Europe.

Clinerion has been certified by EHDEN (European Health Data & Evidence Network) to map health data from various formats to the OMOP common data model. As an OMOP ambassador, Clinerion will support the speeding up of the process to map health data from various formats and institutions to the OMOP common data model in Europe.

Clinerion was selected as one of eleven SMEs (Small and medium-sized enterprises) from a pool of twenty-eight eligible applications to the first EHDEN pilot call this year, to be trained and certified, with the objective to speed up the process to map health data from various formats and institutions to the OMOP common data model.

EHDEN aims to develop a federated and equitable ecosystem of institutions generating clinical data, with researchers across academia and industry, supported by certified and qualified SMEs, harmonizing clinical data and creating a network technology for real-world research. It will incorporate appropriate policy and regulatory requirements, such as the General Data Protection Regulation (GDPR) and ethical research guidelines, via privacy by design in its sociotechnical infrastructure.

Central to EHDEN will be the standardization of health data to the โ€˜Observational Medical Outcomes Partnershipโ€™ (OMOP) common data model (CDM) and the utilization of analytical tools such as those developed by the international โ€˜Observational Health Data Sciences and Informaticsโ€™ (OHDSI) open science collaboration and others.

EHDEN aims to harmonize 100 million anonymised health records over five years across multiple hospitals, primary care networks, regional databases, and similar, while developing a durable and sustainable network of mutual research interests. During the project, numerous use cases will validate EHDENโ€™s work with a focus on health outcomes, measured by relevant health outcome standards.

โ€œWe warmly welcome this initial group of SMEs, says Associate Prof. Peter Rijnbeek, Erasmus Medical Center, Rotterdam, The Netherlands and Coordinator of EHDEN. โ€œEHDEN provides SMEs with free training and certification, an ability to expand their market presence and work with our Data Partners, and to be part of a transformational initiative that will have positive impact on patient outcomes across Europe through open science.โ€

โ€œEstablishing this SME network throughout Europe is a critical step in building an eco-system that supports a range of Data Partners and other stakeholders in mapping and using health data,โ€ says Nigel Hughes, Janssen Scientific Director RWD/WRE, and Co-Lead of EHDEN. โ€œCertified, these SMEs, together with the Data Partners that will be joining in the coming months and years, become a key part of the EHDEN community,โ€ he added.

โ€œClinerion is proud to be certified by EHDEN in its efforts to tap into the potential of real-world data,โ€ says Ian Rentsch, CEO of Clinerion. โ€œIn our support of the improvement of patient treatments and outcomes, we are dedicated to rendering patient data worldwide mutually intelligible and the OMOP data model is fully interoperable with Clinerionโ€™s Patient Network Explorer. We look forward to working closely with EHDEN and OHDSI on tapping into the transformational potential of real-world data.โ€

About Clinerion

Clinerion accelerates clinical research and medical access to treatments for patients. We use proprietary technologies for analysis of patient data from our global network of partner hospitals. Clinerion’s Patient Network Explorer radically improves the efficiency and effectiveness of clinical trial recruitment by offering data-driven protocol optimization, site feasibility evaluation and real-time patient search and identification to match patients to treatments. Our technology solution provides real-world evidence analytics for medical access. Clinerion facilitates the participation of partner hospitals in leading-edge, industry-sponsored trials and time savings in patient recruitment. We create innovative and disruptive fit-for-purpose solutions which enable pharmaceutical companies to shorten patient recruitment and save costs by streamlining operations and leveraging strategic intelligence. Clinerionโ€™s proprietary Big Data analytics technologies leverage real-time data from electronic health records which comply with international patient privacy and data security regulations. Clinerion is a global data technology service company headquartered in Switzerland.

Shoulder Innovations Announces FDA 510 Clearance For Inset Plus Augmented Glenoids For Total Shoulder System

Shoulder Innovations Announces FDA 510 Clearance For Inset Plus Augmented Glenoids For Total Shoulder System

Shoulder Innovations, (SI), a leading innovator in the development of shoulder replacement systems, announced that they have received FDA clearance for their InSet Plus augmented glenoids for the InSet Total Shoulder System.

The InSetโ„ข Total Shoulder System is used to treat significant disability in degenerative, rheumatoid and traumatic disease of the glenohumeral joint and avascular necrosis of the humeral head. The InSetโ„ข System includes patented inset glenoid technology, originally innovated by Stephen Gunther, M.D. The new InSet Plusโ„ข glenoids feature an angled articular surface and are available in both 5ยฐ and 10ยฐ variants with multiple diameters.

David Blue, Chief Commercialization Officer for Shoulder Innovations said, โ€œIn the United States, there are more than 100,000 total shoulder patients operated on annually, with demand for the procedure growing at approximately 10% per year. Surgeons are seeking implant systems that can help to reduce implant loosening and revision rates, therefore increasing patient satisfaction and reducing overall healthcare costs.โ€

Results published in the Journal of Shoulder and Elbow Surgery (JSES) show improved implant stability with the Shoulder Innovations InSetโ„ข Shoulder System, demonstrating an 87 percent reduction in implant micro-motion as compared to conventional glenoid design. Additional results published in JSES show there were no complications, no cases of glenoid implant loosening and no revision surgeries performed in the series at a mean 8.7 year follow-up.

Don Running, Vice President, Research and Development for Shoulder Innovations explained, โ€œThe key to the long-term clinical success of the InSetโ„ข glenoid has been both the unique flat back design and novel bone pocket created in the fossa to allow for a secure fixation that is โ€œset inโ€ the subchondral bone. With the new InSet Plusโ„ข design, surgeons have the ability to create optimal pocket depths on more eroded glenoid faces while still providing significant version correction. In addition, due to the circular nature of the implant design, surgeons are able to dial the augmentation to provide stability in multiple positions.โ€

The Shoulder Innovations InSetโ„ข System simplifies shoulder replacement technology in order to improve patient outcomes.

Mr. Blue added, โ€œWe are excited to see the InSetโ„ข glenoid product line expanded to include our InSet Plusโ„ข glenoid. This innovation shares the same simplicity of our primary InSetโ„ข glenoid, while offering surgeons the opportunity to simply โ€œdial-inโ€ the desired correction. Surgeons appreciate the fact that they donโ€™t have to commit to a specific configuration until they are at the trial stage and no new instrumentation is required for this benefit. The long-term vision of Shoulder Innovations is to offer a complete leading technology shoulder arthroplasty product line and the addition of the InSet Plusโ„ข is another step in that direction.โ€

About Shoulder Innovations

Shoulder Innovations, LLC is a medical device development company which designs and commercializes innovative products which demonstrate the potential for improved patient care and reduced overall cost to the healthcare system.

Leveraging its breakthrough, patented, inset glenoid design, Shoulder Innovations is commercializing a shoulder replacement implant system focused on improving outcomes related to the greatest cause of shoulder replacement failure: glenoid loosening.

The InSetโ„ข technology has been shown in testing to significantly reduce glenoid implant micro-motion and simplifies surgical the surgical technique, potentially reducing complications or increase implant longevity.

CathWorks FFRangio System Receives Regulatory approval for Japan

CathWorks FFRangio System Receives Regulatory approval for Japan

CathWorks announced the approval of The CathWorks FFRangioโ„ข System by the Japanโ€™s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, including color-coded 3D renderings of blood flow in the heartโ€™s arteries to help physicians optimize coronary artery disease decision making, including whether a stent is needed

The CathWorks FFRangio System is also commercially available in the United States and Europe. It is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs. The technology has the potential to positively impact a significant patient population in Japan, where heart disease is the second leading cause of death and coronary artery disease accounts for approximately half of these deaths.

โ€œThe MHLWโ€™s approval of The CathWorks FFRangio System is another important milestone for CathWorks, physicians and patients. It is the first non-invasive device of its kind to receive Japan MHLW approval for use during Percutaneous Coronary Intervention (PCI) and to determine the optimal treatment for patients with coronary artery diseaseโ€ said Jim Corbett, CEO of CathWorks. โ€œWith this approval in Japan, we are positioned to significantly expand our ability to help more clinicians optimize coronary artery disease therapy decisions non-invasively while reducing unnecessary invasive catheterizations and saving costs.โ€

ABOUT CATHWORKS

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize coronary artery disease therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers. The companyโ€™s focus is specifically on bringing the CathWorks FFRangio System to market to provide quick, precise, and objective intraprocedural FFR guidance that is practical for every case. For more information, visit www.cath.works

 

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