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Northwell Labs begins manual testing of COVID-19 samples

Northwell Labs begins manual testing of COVID-19 samples

After a visit to its sophisticated, 100,000-square-foot diagnostic facility by New York Governor Andrew Cuomo, Northwell Health Labs received state and federal authorization to begin manual testing for COVID-19, the disease caused by the novel coronavirus.

Utilizing a testing process developed and approved by the New York State Department of Health (DOH), Northwellโ€™s Lab expects to manually test 90 potential COVID-19 samples within the first full day, said Dwayne Breining, MD, executive director of the Northwell Labs. With one of North Americaโ€™s largest automated testing lines, the facility processes about 20 million tests annually. Beyond the manual testing authorized, Northwell Labs is seeking the US Food & Drug Administrationโ€™s approval to use semi-automated testing within the next week. This would give the laboratory the capability to process hundreds of tests daily, with a plan to ramp up to thousands daily in the near future.

โ€œOver the past week, weโ€™ve been developing the test for COVID-19, thanks to the assistance weโ€˜ve received from New York Stateโ€™s DOH Laboratory,โ€ said Dr. Breining. โ€œNow that the accuracy of our testing process has been validated, we can begin notifying providers and patients of their lab results and start gearing up for an automated testing process that would enable us to significantly expand the number of samples we can process.โ€

While the expanded ability to test patients for COVID-19 will greatly enhance Northwellโ€™s ability to manage patients with potential infection, testing will continue to be reserved for those at risk for severe disease and who have had confirmed close contact with an infected individual.

โ€œOnly people who meet that criteria will be tested โ€“ and that testing is currently being performed at hospital emergency departments and urgent care centers,โ€ said John Dโ€™Angelo, MD, chair of emergency medicine at Northwell, which operates 18 emergency departments throughout New York City, Long Island and Westchester County. โ€œEven as our testing capacity increases, we will continue to screen people judiciously so we can focus our attention on those most at risk for severe COVID-19 infection who require more-immediate and intensive medical attention. All others who are concerned about exposure but who have mild or no symptoms should recuperate at home.โ€

Northwellโ€™s 100,000SF Core Lab ramps up testing

Built at a cost of $60 million and opened in 2019, Northwellโ€™s Core Lab within the health systemโ€™s Center for Advanced Medicine in Lake Success performs testing for Northwellโ€™s 23 hospitals and 800 outpatient facilities, as well as thousands of physician offices and dozens of other hospitals, including NYC Health+Hospitals.

At a news conference Sunday morning, Governor Cuomo called on the federal government to speed up its authorization process to allow more clinical laboratories to begin testing for COVID-19. โ€œThis is one of the most technologically advanced labs in the state of New York, and one of the most sophisticated labs in the United States of America. This lab can do high-throughput automated testing, which expands exponentially the number of tests that can be done,โ€ Governor Cuomo said. โ€œLetโ€™s increase as quickly as possible our testing capacity so we identify the positive people, so we can isolate them and be successful in our containment.โ€

Several hours after the Governorโ€™s news conference, Northwell received approval to move forward with the manual testing.

Northwell Health President & CEO Michael Dowling praised the Governor and state Department of Health for their leadership in responding to the coronavirus epidemic. โ€œI thank the Governor for not only giving us the support we need to begin testing for COVID-19, but also in declaring a state of emergency that will help expedite the procurement of emergency provisions, such as testing kits and cleaning supplies,โ€ said Mr. Dowling.

To prepare its lab to begin COVID-19 testing, Northwell has invested over $2 million in recent weeks for lab supplies and equipment, part of an overall outlay of more than $5 million the health system has spent over the past seven weeks on coronavirus preparation.

SymphonyAI Acquires Medical-Imaging Company TeraRecon

SymphonyAI Acquires Medical-Imaging Company TeraRecon

SymphonyAI Group, an operating group of leading business-to-business AI companies, announced the acquisition of TeraRecon, the market-leading advanced visualization and AI solution provider for medical imaging. As SymphonyAI Groupโ€™s seventh portfolio company, TeraRecon has a charter to establish a new portfolio of healthcare AI solutions focused on medical imaging.

Using newly patented AI and platform technology, TeraRecon will continue to focus on expanding its open platform for advanced visualization and AI-driven solutions. TeraRecon will accelerate the use of AI in other clinical specialties, including neurology and oncology, in addition to its market-leading solutions in radiology, cardiology, and vascular surgery.

SymphonyAI Group will invest in infrastructure and key initiatives to rapidly produce new advancements and offerings through TeraReconโ€™s industry-leading engineering and product teams. TeraRecon will operate as an independent portfolio company in the SymphonyAI Group. Synergies with TeraRecon technologies will complement the precision oncology offerings of portfolio company Concerto HealthAI.

Used by over 900 health systems globally, TeraRecon solutions provide radiologists and other highly specialized physicians with the software tools they need to quickly visualize and extract critical clinical data from medical images.

Jeff Sorenson, president and CEO of TeraRecon, said, โ€œIn just a few years, our company has not only transformed the realm of advanced visualization with artificial intelligence but also our entire industry. Now with the backing of SymphonyAI Group and the recent recognition of two powerful patents, TeraRecon can think bigger and work faster than ever before. Having been chosen for such an impressive and selective portfolio is truly an honor, and an ideal outcome for our employees, customers, and stockholders.โ€

Dr. Romesh Wadhwani, founder and CEO of SymphonyAI Group, said, โ€œThe SymphonyAI Group mission is to use AI to transform the enterprise. We accelerate high-value AI solutions to market to meet the needs of specific vertical industry use cases. TeraRecon has demonstrated the value AI can play in the medical imaging market. We believe that TeraRecon AI technology can continue to deliver unprecedented benefits to doctors and patients and expand into new areas of the healthcare enterprise.โ€

Vibhor Rastogi, investment partner at SymphonyAI Group, said, โ€œArtificial intelligence in medical imaging is expected to deliver several breakthroughs spanning a wide range of clinical areas and modalities. With the acquisition of TeraRecon, SymphonyAI Group is bolstering its portfolio of AI-enabled enterprise solutions for the healthcare and life sciences industries. We are committed to leveraging AI to deliver breakthrough therapies and care delivery models.โ€

TeraRecon CEO Jeff Sorenson will be joined on the companyโ€™s board of directors by SymphonyAI Group CEO Romesh Wadhwani and partners Vibhor Rastogi, Leif Pedersen, and Pradyut Shah.

TeraRecon will demonstrate its full suite of AI-driven technologies at the upcoming Health Information and Management Systems Society (HIMSS) 2020 Annual Meeting March 9-13th in Orlando, Florida and the European Congress of Radiology (ECR) 2020 Annual Meeting July 15-19 in Vienna.

Cantor Fitzgerald & Co. acted as exclusive financial advisor to TeraRecon in connection with the transaction.

About TeraRecon

TeraRecon is a leader in medical advanced visualization and artificial intelligence solutions. Their flagship product, iNtuition, consistently leads the advanced visualization category of the industryโ€™s leading independent technology analyst. The company continues to innovate ahead of customer demand and has most recently developed sophisticated healthcare-focused artificial intelligence platform solutions unlike any in the world today. EnvoyAI was the recipient of the prestigious Aunt Minnie 2018 Best New Radiology Vendor award. TeraReconโ€™s Northstar AI Results Explorer is the first and only enterprise-wide solution capable of delivering AI imaging insights directly and interactively into the systems clinicians use every day. As a company with a 20-year history of innovation, TeraReconโ€™s mission is to continuously redefine medical advanced visualization and leverage artificial intelligence to improve patient care.

About SymphonyAI Group

SymphonyAI Group is the fastest-growing private group of B2B AI companies, backed by a $1 billion commitment to deliver next-generation AI solutions for transforming the enterprise. SymphonyAI Group addresses use cases in healthcare and life sciences, retail and CPG, industrial manufacturing, energy, oil & gas, media and entertainment, defense, and financial services. Since its founding in 2017, SymphonyAI Group has grown rapidly to a group of seven companies with a combined revenue run rate of more than $300 million. Over 2,000 talented leaders, data scientists, and other professionals operate the group under the leadership of one of Silicon Valleyโ€™s most successful serial entrepreneurs, Dr. Romesh Wadhwani.

Tivic Health Announces CE Mark Approval for ClearUP Sinus Relief

Tivic Health Announces CE Mark Approval for ClearUP Sinus Relief

Tivic Healthยฎ Systems Inc., announced that ClearUPยฎ Sinus Pain Relief, a small handheld device that delivers a proprietary microcurrent waveform, has received CE Mark approval for temporary relief of sinus pain, pressure and congestion, under the brand name ClearUP Sinus Relief. The combination of the Companyโ€™s FDA Clearance and CE Mark approval opens the market for ClearUP to sell in over 190 countries.

Tivic Health will evaluate opportunities for international expansion through direct sales, partnerships, and retail distribution to establish a presence in overseas markets in 2021. ClearUP is part of a wave of new non-invasive neuromodulation devices coming to market that provide safe, non-drug options for patients with a variety of medical conditions.

โ€œWe have had overwhelming interest both from customers and distributors in international markets,โ€ said Jennifer Ernst, CEO of Tivic Health. โ€œWith the worldwide growth in sinus and allergy diseases, we look forward to forming strong partnerships to launch ClearUP internationally. For decades, the medical community has focused on treating conditions almost exclusively with chemical and drug therapies. We now see a growing number of companies exploring bioelectronic medicine โ€“ replacing drugs with targeted electrical stimulation. I am excited to be delivering one of the first non-prescription bioelectronic solutions to mainstream markets.โ€

About ClearUP

Clinically proven, and FDA cleared, ClearUP is a small handheld device that is drug-free, has no chemical side effects and is available over-the-counter without a prescription to help 50+ million allergy sufferers in the U.S. manage their sinus pain. To use, glide ClearUP along the outside of your cheek, nasal bone and around the brow bone for a quick five-minute treatment. ClearUP guides the user to the most optimal treatment points with its light and vibration system. As ClearUP vibrates, it delivers a low-level, proprietary electrical stimulation waveform called microcurrent that stimulates sinus nerve fibers under the skin of the face to relieve sinus pain. There is a one-button control and three levels of customization.

About Tivic Health Systems Inc.

Tivic Health is a bioelectronic device company dedicated to developing microcurrent therapy solutions to treat chronic diseases and conditions. ClearUP has received awards from: Last Gadget Standing at CES 2020, Digital Trends Best Health Gadgets CES 2020, TIMEโ€™s 2019 Best Inventions and CES 2020 Innovation Honoree Award. Founded in 2016, Tivic Health is part of a $6.2B global bioelectronics industry and is dedicated to harnessing the power of neuromodulation for home use products and empowering people to improve their health and quality of life.

AI-Pathway Companion Prostate Cancer from Siemens Healthineers approved for use in Europe as medical device

AI-Pathway Companion Prostate Cancer from Siemens Healthineers approved for use in Europe as medical device

AI-Pathway Companion Prostate Cancer, a digital companion from Siemens Healthineers to support clinical decision-making, has recently received the CE mark for use in the clinical pathway of prostate cancer, the second most common cancer (after lung cancer) affecting males worldwide. The conformity mark confirms that the application AI-Pathway Companion Prostate Cancer is CE-compliant in accordance with Directive 93/42/EEC and can therefore be marketed in the EU as a medical device.

The AI-Pathway Companion product suite uses Artificial Intelligence, including Natural Language Processing, to bring together data on a patientโ€™s disease and treatment status and presents it via an intuitive graphical user interface. AI-Pathway Companion Prostate Cancer also draws the physiciansโ€™ attention to the appropriate treatment recommendations from the prostate cancer guidelines of the European Association of Urology and the National Comprehensive Cancer Network to suit the patientโ€™s current treatment status.

โ€œThe AI-Pathway Companion helps multidisciplinary teams in particular with decision-making for diagnosis and treatment along the entire clinical pathway on the principles of evidence-based medicine. That means we can assist healthcare providers to put the individual patient at the center of the treatment process. We are very excited about AI-Pathway Companion as one of the first elements in our strategy of expanding to clinical decision making based on integrated diagnostics,โ€ says Andrรฉ Hartung, head of Diagnostic Imaging at Siemens Healthineers.

Decision-making for treatment and the follow-up process for prostate cancer is extremely complex and time consuming, since many individual patient parameters must be considered. This includes the stage at which the disease was discovered, whether it is a first diagnosis, whether various treatments have already been applied, and whether the tumor has reappeared following an initial treatment success. Lab results, like the PSA (prostate-specific antigen) value, pathology findings from a prostate punch biopsy, or the PI-RADS (Prostate Imaging โ€“ Reporting and Data System) score, which identifies the probability of a clinically significant carcinoma, and the Gleason score, which classifies the aggressiveness of a prostate tumor, are other examples of criteria used by physicians to help determine the next stages of examination and treatment. In the process, the physicians use evidence-based international medical guidelines which generally may run to well over 100 pages and often recommend appropriate, scientifically justified, and up-to-date processes for diagnostics and treatment; these also include the prostate cancer guidelines of the European Association of Urology and the National Comprehensive Cancer Network. It is not hard to see that the mass of data contained in both the results and guidelines can pose a major challenge to decision-making.

AI-Pathway Companion Prostate Cancer helps match the data available for the individual patient with the guidelines to identify the recommended treatment approach and facilitate the appropriate disease management. The digital companion searches the patient record and other sources, like the hospital information system or PACS (Picture Archiving and Communication System), and compiles the longitudinal data for the cancer patient in question.4 Natural Language Processing is used to extract and compile data relevant to the decision-making process from the radiology, pathology, genetics, and lab results, and present it via an intuitive user interface. The PI-RADS score is also automatically correlated with the Gleason score to help physicians estimate the aggressiveness of the tumor and determine the course of the disease on that basis. Algorithms search through the prostate cancer guideline for recommendations that suit the patientโ€™s individual disease status based on his or her current available data. The algorithms automatically show where the patient is in the pathway and recommend next options, including any missing information that is required.

Based on this data, AI-Pathway Companion Prostate Cancer displays the patientโ€™s current clinical situation and offers guideline-based recommendations for further steps to provide treatment in accordance with the medical evidence. The digital companion can thus help multidisciplinary teams at tumor boards, for example, to make optimized decisions throughout the treatment process.

โ€œOur multidisciplinary team (MDT) discussions can greatly vary in time. If a clinical decision support solution could integrate and display the patient context in a smart and standardized way, while providing evidence-based diagnosis and therapy recommendations, it could help make the discussions shorter and save time for all the MDT participants,โ€ says Prof Helge Seifert, MD Chairman, Clinic for Urology at University Hospital Basel.

โ€žI spend a lot of time entering patient information manually in our MDT solution. If this information could be integrated automatically and in a smart and standardized way, it would save us a lot of time and let us focus on what’s important: the patient,โ€œ says Christian Wetterauer, MD Senior Urologist at University Hospital Basel.

Nexelis to Acquire Specialty Immunogenicity and Immune-Oncology Testing Laboratory ImmunXperts

Nexelis to Acquire Specialty Immunogenicity and Immune-Oncology Testing Laboratory ImmunXperts

Nexelis, a portfolio company of Ampersand Capital Partners, and a leading provider of assay development and advanced laboratory testing is pleased to announce the signing of a definitive agreement, subject to conditions precedent, to acquire ImmunXperts. The closing of the transaction is expected by the end of March.

Based in the Brussels South Charleroi Biopark within the town of Gosselies, ImmunXperts has developed and performs a full offering of immunogenicity and immuno-oncology in vitro functional and potency assays. These assays help pharmaceutical and biotech sponsors screen, select and optimize lead compounds before the initiation of in vivo trials. The company, whose CEO is Thibault Jonckheere, was co-created in 2014 by immunology expert Sofie Pattijn, who serves as ImmunXperts CTO, and investors including Sambrinvest. Both Dr Pattijn and Mr. Jonckheere will continue in senior leadership roles at Nexelis.

โ€œImmunXpertsโ€™ immunology testing expertise will help Nexelis more broadly serve the needs of our customersโ€ said Benoit Bouche, Nexelis President and Chief Executive Officer. โ€œNexelis will now have an unrivaled ability to efficiently develop immunogenicity assays, qualify and validate them in a regulated environment, and then ultimately perform them utilizing our high-throughput platforms in support of clinical trials.โ€

Sofie Pattijn and Thibault Jonckheere added โ€œWe are proud of ImmunXpertsโ€™ achievements over the past five years and are grateful for the support obtained from our investors and partners, our employees, and the Wallonia region. We are excited to continue our growth trajectory as part of Nexelis and serve as a European hub for the company.โ€

About Nexelis

With unrivaled expertise in immunology on both sides of the client/CRO relationship, Nexelis is a leading provider of assay development and advanced laboratory testing. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and soluble large molecules.

About ImmunXperts

ImmunXperts offers a wide range of in vitro immunology services with a strong focus on immunogenicity and immuno-oncology. The company helps biopharma companies select their best lead candidates by assessing all aspects of immune responses in donors and patients. Acting as a mobile development team, ImmunXperts complements its clientsโ€™ expertise to deliver meaningful and potent screening tools.

About Ampersand Capital Partners

Founded in 1988, Ampersand is a middle-market private equity firm dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of our core healthcare sectors, including Brammer Bio, Confluent Medical, Genewiz, Genoptix, Talecris Biotherapeutics, and Viracor-IBT Laboratories.

About Sambrinvest

Sambrinvest is a risk capital actor in the region of Charleroi in Belgium, with the objective to support the development of SMEs. Thanks to its expertise, it advises entrepreneurs at every development stage of their projects whilst respecting their management autonomy. Sambrinvest has been active for more than 30 years, with a specific focus on Biotechnology and Digital.

American Oncology Network Continues Strategic Relationship with AmerisourceBergen

American Oncology Network Continues Strategic Relationship with AmerisourceBergen

global healthcare solutions leader AmerisourceBergen announced that it is continuing its strategic relationship with the American Oncology Network, LLC (AON), a high-growth medical oncology provider with a focus on supporting the long-term viability of oncology treatment in community-based settings. AmerisourceBergen will support AON in its effort to accelerate key strategic priorities to scale its integrated value-based care delivery model nationwide.

AON currently serves an expanding network of partner practices across 11 states, providing dedicated end-to-end administrative support, access to an extensive array of centralized ancillary services, and proven practice management expertise. Delivered through its local market, physician-led model, AON empowers community-based practices with the necessary tools, support and capital to effectively navigate increasingly dynamic healthcare landscape and practice value-based care within the community at scale.

โ€œOur partnership with AmerisourceBergen is an important part of our effort to grow our network, expand our solution suite, and deliver exceptional services to our partner practices and their patients,โ€ said AON CEO Brad Prechtl, MBA.

AON Board Member & Chairman Dr. Stephen Orman added, โ€œAmerisourceBergen is an industry leader with a proven track record of achieving exceptional results, and we look forward to collaborating further to expand our national oncology network.โ€

AmerisourceBergenโ€™s ION Solutions supports AON with GPO contracting. Oncology Supply handles distribution of chemotherapy and supportive care products to AON practices. Additional integrated service offerings available to AON practices through ION and Oncology Supply include:

  • Dedicated account teams that actively consult on inventory and creating operational efficiencies
  • Robust inventory of specialty and full-line oral, infusible and injectable products
  • Technology, analytics and informatics solutions to drive higher-quality and lower-costs
  • Inventory management solutions
  • Centralized library of precision medicine testing recommendations and resources through ION Solutionsโ€™ Precision Medicine Center
    Ongoing educational conference series designed to facilitate peer-to-peer learning and networking and strengthen the community of independent oncologists
  • The largest, longest-tenured pharmacy program that assists community oncology practices in successfully optimizing a medically integrated dispensing program

โ€œAs a company thatโ€™s pharmaceutical-centered and community focused, we strive for partners like AON,โ€ said Brian Ansay, President Specialty Physician Group Purchasing, AmerisourceBergen. โ€œAONโ€™s physician-led model and patient-centric services are creating new opportunities in community oncology, and we are excited about their vision for the future.โ€

AON is physician led and physician governed

About American Oncology Network, LLC:

American Oncology Network, LLC (AON) is an alliance of physicians and seasoned healthcare leaders partnering to ensure the long-term success of community oncology. Launched in 2018, the rapidly growing AON network represents 72 physicians and 38 nurse practitioners and physician assistants practicing across 11 states. The executive management team of AON brings more than three decades of oncology practice management experience, enabling physicians to focus on what matters most โ€“ providing the highest quality care for patients.

The organization provides unique and comprehensive protocols for managing administrative procedures and enhancing ancillary services for its affiliates. AON is able to aggregate volume and attain economies of scale, as it guides its member physicians and practices through the transition to value-based reimbursement models that improve the patient experience and help to reduce the per-capita cost of cancer care.

AON also provides a unique model of physician led, community-based oncology management. With services such as a centralized specialty pharmacy, diagnostics, pathology, fully integrated electronic medical records, a care management team and a variety of financial assistance programs, an alliance with AON ensures that patientsโ€™ experiences will be at the very pinnacle of cancer care today.

About AmerisourceBergen

AmerisourceBergen provides pharmaceutical products, value-driving services and business solutions that improve access to care. Tens of thousands of healthcare providers, veterinary practices and livestock producers trust us as their partner in the pharmaceutical supply chain. Global manufacturers depend on us for services that drive commercial success for their products. Through our daily workโ€”and powered by our 22,000 associatesโ€”we are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #10 on the Fortune 500, with more than $175 billion in annual revenue. The company is headquartered in Valley Forge, Pa. and has a presence in 50+ countries.

 

Jump Technologies, Ballad Health offer free webinar on enhancing performance of hospital supply chain

Jump Technologies, Ballad Health offer free webinar on enhancing performance of hospital supply chain

Jump Technologies and Ballad Health System will offer a free webinar on March 18 at 1:00 p.m., ET, to discuss the benefits of implementing supply chain technology that complements a hospitalโ€™s existing ERP software.

The webinar will draw on experiences at Ballad Health, which operates 21 hospitals in 29 counties in Tennessee, Virginia, North Carolina, and Kentucky to demonstrate the outcomes and benefits Ballad has realized from enhancing their existing Lawson ERP system with a third-party solution from Jump Technologies. The JumpStock solution integrates seamlessly with Balladโ€™s existing ERP to enhance reporting with real-time data and analytics, allowing Ballad to:

  • Free up cash by reducing on-hand inventory;
  • Save time with simple one-click-and-done barcode scanning;
  • Improve order accuracy with automated PAR adjustments based on velocity; and
  • Improve nursing satisfaction with supply chain.

Presenters will demonstrate how Ballad and other leading hospitals are finding safe, secure, and cost-effective ways to maximize the performance of their ERP systems with third-party supply chain technology.

“By pairing Jump Technologies with our Lawson ERP system, weโ€™ve been able to improve supply chain performance and implement a 2-bin Kanban approach at four locations,โ€ said Dennis Couch, materials management site manager, Ballad Health. โ€œItโ€™s a safe, simple, and economical solution that has allowed us to reduce time spent scanning items, improve our workflows, and make point-of-use decisions about PAR based on real-time data.”

About Jump Technologies

Jump Technologies creates safe, simple, and cost-effective solutions that help hospitals reduce stockouts, overordering, and waste while increasing inventory turns and improving billing accuracy across a facility or system. The companyโ€™s JumpStock solution facilitates data-driven decision making that allows hospitals to save time, free up cash, and improve nurse satisfaction with supply chain.

V-Wave Receives CE Mark for the Ventura Interatrial Shunt System

V-Wave Receives CE Mark for the Ventura Interatrial Shunt System

CE Mark for the Venturaโ„ข Interatrial Shunt System is a significant milestone for V-Wave, as it recognizes that this therapeutic product conforms to the standards of the European Medical Device Directive

V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), announced that its Venturaโ„ข Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union.

โ€œMore than 26 million people suffer from chronic heart failure worldwide, and HF remains a leading driver of disability and acute hospitalization, particularly in the growing elderly population,โ€ noted V-Wave Chief Medical Officer and renowned heart failure cardiologist, William T. Abraham, MD. โ€œDespite decades of advances, heart failure patients continue to progressively deteriorate, enduring disabling symptoms, having a poor quality of life, diminished exercise tolerance, and a markedly reduced life expectancy. The minimally invasive implanted Ventura Interatrial Shunt relieves excessive pressure in the left-side of the heart, thereby reducing the build-up of fluid in the lungs, which is the most common reason for worsening HF symptoms, exercise limitation, and HF hospitalizations.โ€

The Ventura Interatrial Shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient U.S. Food and Drug Administration (FDA) IDE pivotal trial called RELIEVE-HF, which is designed to demonstrate safety and effectiveness of shunt therapy in reducing HF morbidity and mortality and improving functional status. The study is enrolling advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies. Approximately 100 of the top hospitals in North America, Europe and Israel are or will be participating.

โ€œCE mark for the Ventura Interatrial Shunt System is a significant milestone for V-Wave, as it recognizes that this therapeutic product conforms to the standards of the European Medical Device Directive,โ€ said V-Wave CEO Neal Eigler, MD. โ€œAlong with the FDA Breakthrough Device Designations we received last year, CE Marking will help accelerate the introduction of our potentially impactful clinical treatment to the millions of patients suffering from heart failure.โ€

About V-Wave Ltd.

V-Wave is a privately held medical device company with offices in Israel and the U.S. In addition to developing interatrial shunt device technologies for the treatment of heart failure, V-Wave is exploring the use of such technologies for the treatment of Pulmonary Arterial Hypertension in an FDA IDE Early Feasibility Study.

Coronavirus in SA – Hygiene and prevention measures the cornerstone of infection control

 Coronavirus in SA - Hygiene and prevention measures the cornerstone of infection control

The news of the first known case of the novel coronavirus (2019-nCov) in South Africa follows confirmed cases in both Algeria and Nigeria. South African health officials, including Health Minister Mkhize, however, are confident in our nationsโ€™ ability to contain the spread and avoid catastrophe.

The WHO (World Health Organization), has warned that an outbreak on African soil is practically inevitable. Despite this the Ministry of Health has assured the public that SA is well-prepared to deal with any crisis, and the WHO, have rated SA highly in various technical assessments and has expressed faith in our ability to cope.

Emma Corder, Managing Director of industrial cleaning service provider Industroclean believes that hygiene and prevention measures are the cornerstone of infection control and that the uncertainty surrounding the virus necessitates extra precautionary rigour in areas where the disease could be passed on, like public spaces, airports and hospitals.

โ€œSince there is still lack of clarity on various aspects of the virus, such as the exact incubation period and how often asymptomatic people are passing on the virus, it is imperative that we take preventative measures against an outbreakโ€, she says.

Corder adds that a ready supply of surgical gloves, fitted N95 respiration masks, and sampling swabs must be ensured at both airports and designated quarantine zones.

โ€œPersonal protective equipment, hand hygiene, as well as sterilization of tools, and environmental cleansing and disinfection are absolutely crucial in an outbreak situation, as even the slightest breach in protocol could lead to loss of life or illness on a large scale,โ€ she says.

At present all incoming air-passengers are screened for high-temperature and flu-like symptoms โ€“ fever, cough, difficulty breathing โ€“ and those that are red-flagged are immediately quarantined and examined by health care professionals at the point of entry.

Several hospitals around the country have been designated to establish preemptive quarantine zones for the virus. These sites were chosen because of their proximity to our biggest international airports, but also for their ability to contain its spread, and conduct research.

With over 96 600 known infections across the globe and over 3 300 reported deaths the potential spread of the virus is a foremost concern for public health specialists right now.

โ€œThe race to prevent further spread and the uncertainty around the virus require that strict hygiene and other infection prevention protocols are observed in any area where the virus could spreadโ€, concludes Corder.

Surgery Assistance Smart Glasses: New tech partnership means revolution in the Operating Theatre

Surgery Assistance Smart Glasses: New tech partnership means revolution in the Operating Theatre

Surgery Assistance smart glasses, which are specifically customised for use during surgeries, are set to completely transform communication and interaction in the operating theatre.

Iristick and Rods&Cones announce their partnership to create a technology solution that will revolutionise real-time collaboration in the OT โ€“ between surgeons, attending surgeons, and product experts: a total solution for remote assistance in surgery.

Introducing Surgery Assistance smart glasses โ€“ a powerful new device and software solution thatโ€™s set to completely transform the way that surgeries are performed.

Developed by pioneering Amsterdam-based medical device experts Rods&Cones, and Antwerp/New York-based technology specialists Iristick, these smart glasses enable real-time remote collaboration between OR surgeons, attending surgeons, and product experts โ€“ without all of them needing to be physically present in the same room.

High Tech, But Easy To Use

The easy-wear, high-tech smart glasses are equipped with two individual cameras, microphones, and a powerful optical zoom lens โ€“ which can be operated by the remote assistant; giving an unrestricted, close-up view of each surgeryโ€™s progress and real-time feedback.

The smart glasses feature a QR code scanner which enables surgeons to โ€˜dial-inโ€™ colleagues and or industry experts, simply by looking at the right code. The smart glasses will respond to voice commands and are guaranteed to have enough battery capacity to last for up to 8 hours โ€“ meaning they can last for an entire hospital shift.

Rods&Cones is the only remote assistance solution fully adapted to the sterile operating environment. All the functions of the smart glasses are remotely controlled and do not require the surgeon to touch the glasses while operating. Additionally, the design team at Rods&Conesโ€™ have made specific enhancements to handle X-ray video feeds, high contrast screens of in-theatre devices and red balance issues. Rods&Cones selected Iristick glasses as their technology platform due to their comfort, ergonomics and suitability for use in surgery. Through the Iristick open platform, Rods&Cones has been able to integrate its bespoke software resulting in this powerful and innovative solution.

Unique, lightweight, and comfortable; the smart glasses can be set up quickly by hospital technicians โ€“ or even by doctors themselves. The solution comes ready to use out of the box. All the user needs to do is turn on the pocket unit and look at the right QR code when needed.

Increased Efficiencies That Promote Safety

Iristickโ€™s smart glasses allow surgeons to have almost instant access to the best available advice during surgery, while increasing efficiency and knowledge transfer, shortening intervention times, reducing travel times and costs โ€“ with the ultimate aim of helping improve patient safety and outcomes.

“Surgeons are isolated from many support systems because of the safety and sterility regulations,โ€ explained Johan De Geyter, CEO Iristick. โ€œBut thanks to Rods & Conesโ€™ software platform โ€“ customised with our smart glasses โ€“ surgeons can connect easily, zoom in on the smallest details, and complete more successful surgeries โ€“ hands free, quickly and effectively.”

โ€œWe believe our partnership with Iristick has the potential to revolutionise the way surgeries are conducted and make healthcare more efficient in many ways,โ€ said Bruno Dheedene, Rods&Cones co-founder, CEO, and veteran medical devices sales specialist.

โ€œWeโ€™ve seen the need firsthand in hospitals across Europe and tests show that there are immediate benefits straight away, from an efficiency and cost perspective. And given that they could be used anywhere with an internet connection; thereโ€™s huge potential for their use in fieldwork โ€“ especially in more remote locations where surgeons are in limited numbers.โ€

Trials done Q3 and Q4 2019, have yielded very positive results and both companies are keen to partner with other device manufacturers, hospitals, emergency providers, charities and medical professionals.

ABOUT RODS&CONES
Rods&Cones was founded in Amsterdam, Netherlands with a mission to help surgeons all over the world to create a more efficient work environment. Rods&Cones started development of the Surgery Assistance smart glasses in 2017 and commercial activity began in 2019. Rods&Cones started development of the Surgery Assistance smart glasses in 2017 and commercial activity began in 2019. Rods&Cones has offices in Amsterdam and Turnhout, Belgium.

ABOUT IRISTICK
Founded in 2016, Iristick creates industrial smart glasses to support enterprises and healthcare workers in their digital transformation. Iristick empowers the deskless operators of the Industry 4.0 future in three domains: remote assistance, digital procedures and pick-by-vision logistics. Iristick smart glasses are currently being used and tested by customers in maintenance, after-sales support, logistics, shop floor activities, quality control, tele-medicine and healthcare. Iristick, based in Antwerp, Belgium and New York, USA supports customers globally. Winner of a Red Dot Award 2018.

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