The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”

The FDA will continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology. The agency is appointing Bakul Patel as the first director. Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.

“The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” said Jeff Shuren, M.D., J.D., director of CDRH. “In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”

The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.

The Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. While there are many aspects of the Digital Health Center of Excellence that are still under development, ultimately the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Royal Philips, a global leader in health technology, today announced the launch of the innovative QuickClear mechanical thrombectomy system. The compact, single-use system provides an all-in-one aspiration pump and catheter for the removal of blood clots from the vessels of the peripheral arterial and venous systems. The system’s innovative all-in-one design is simple to use while eliminating the need for capital equipment or costly accessories, with easy setup supporting faster procedures times. The Philips QuickClear Mechanical Thrombectomy System has received U.S. FDA 510(k) clearance and is available for sale in the U.S.

“This novel thrombectomy system is the latest addition to Philips’ market-leading portfolio for the diagnosis and treatment of peripheral vascular diseases,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “Its intuitive design simplifies the entire thrombectomy procedure workflow. By taking away the high initial capital expenditure costs associated with traditional mechanical thrombectomy systems, QuickClear can help bring cost-effective solutions to both the hospital and outpatient care settings.”

Simple, optimized performance

QuickClear simplifies the entire thrombectomy procedure workflow. The small footprint of the sterile device allows it to be placed easily and conveniently on the table next to the patient. With the touch of a button, the system is up and running at maximum aspiration power within seconds. The consistency of the aspiration power during the procedure provides physicians more control and supports faster procedure times. The system’s range of catheters includes a large 10F aspiration catheter, providing 59% more aspiration volume than 8F aspiration catheters.

“QuickClear is a simple and easy to use mechanical thrombectomy system,” said Bryan Fisher, MD, Chief of Vascular Surgery, Tristar Centennial Medical Center, Nashville, U.S. “The system is significantly smaller than other systems without compromising aspiration power. The convenience of the device really shines through with its single use and lack of capital equipment. I am excited about the potential of this device and the impact it will have on my practice and the patients I treat.”

Philips’ peripheral vascular portfolio already includes advanced interventional imaging systems for precision guidance; intravascular ultrasound (IVUS) catheters to assess the location of the disease and lesion morphology and guide and confirm the treatment; peripheral atherectomy devices to remove blockages; and peripheral therapy devices, such as Philips’ Stellarex drug-coated balloon, to treat lesions. Philips recently further extended this portfolio with the acquisition of Intact Vascular, maker of the Tack Endovascular System, a first-of-its-kind, minimal-metal, dissection repair device that provides precision treatment of peripheral arterial dissections following balloon angioplasty in above-the-knee (ATK) and below-the-knee (BTK) therapeutic interventions.

New Cardiovascular Horizons digital symposium

Today, September 24th at 19:00 ET Philips will host a symposium entitled ‘QuickClear Mechanical Thrombectomy System: A Powerfully Simple and Cost-Effective Solution’ as part of the New Cardiovascular Horizons (NCVH) digital education series. To register, visit here.

The Philips QuickClear Mechanical Thrombectomy System is U.S. FDA 510(k) cleared and available for sale in the U.S., with future expansion of availability to other geographies planned

About Royal Philips

Royal Philips is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries.

IDSolutions (IDS), end-to-end telehealth solution provider, and Tryten, manufacturer of healthcare and education carts, announced they are expanding their joint solution offering in healthcare.

IDS first teamed up with Tryten in 2018 during the creation of MedSitter, their second-generation remote patient observation solution. MedSitter’s hardware and patent-pending software applications are deployed on Tryten’s Nova Tall medical carts.

As the Covid-19 pandemic continues to unfold, the two companies agreed to expand their combined offering to support additional telemedicine use cases: Virtual Visitations, Video Intercom, and Virtual Rounding. By incorporating Tryten’s cart with IDS’ hardware + software integration capabilities, the organizations are ensuring their customers obtain every ounce of value from their hardware investment.

Given all the stressors that have been placed on our healthcare system in the last 8 months, it is critical to make solutions available that are not only safe, flexible and affordable, but are easy to implement, support and use,” says Dr. Deb Jeffries, Global Director of Healthcare for Tryten. “Tryten is proud to be working with IDSolutions so that together we can deliver solutions that truly meet the needs of healthcare systems and help them provide safe care when and where it is needed.”

“We recognize that the telehealth equipment healthcare organizations need for virtual care depend on the specialties they serve,” says Nicholas Luthy, VP of Products at IDS. “Our purpose-built solutions are engineered to be simple, versatile, and clinical. Product offerings range from a lightweight frame with a tablet, to ergonomic carts that accommodate multiple medical grade accessories.”

IDS and Tryten Telehealth Solutions Include:

1. Hardware + Software – Tryten carts are designed and pre-configured with the necessary equipment to run HIPAA compliant video conferencing software or MedSitter, IDS’ cloud-based virtual patient observation solution.

2. Professional Services – a broad portfolio of value-added services is included from consulting, workflow design, engineering, project management, clinical education, and staff training.

3. Contactless Implementation – through the Rapid Response Implementation™ Program, carts arrive fully-assembled and roll-out ready.

4. 24/7/365 Support & Managed Services – IDS’ Platinum Plus support plan provides technical assistance from the IDS Customer Care team including proactive network monitoring, advanced parts replacement, software maintenance & upgrades, and help desk services.

“Our team continues to go above and beyond to respond to the needs of our customers,” says IDS Founder and President, Tracy Mills. “Partnering with Tryten to leverage their industry leading cart is an obvious choice. Tryten’s versatile design is key to delivering solutions that provide our customers new ways to generate value with the same equipment.”

“At Tryten, we are passionate about helping others. Extending the number of ways we can help enable better care and patient outcomes is top of mind. By working with IDSolutions, we are able to help bring high quality turn-key solutions to healthcare providers and ultimately more timely care to patients for better outcomes,” says Tony Jansen, Founder and CEO of Tryten.

Businesses are moving towards the online world, especially with the recent pandemic and the lockdown that it brought. There is potential for huge amounts of earnings, but if it is not handled well, you can quickly watch your business crumble. It might surprise people, but online pharmacies are becoming a thing, with patients getting their medications online. If you are planning on running an online pharmacy business, here is how you can make it a success.

Endorsements From Medical Sites

There are plenty of medical sites out there that talk about prescriptions and illnesses. People often turn to these websites for advice and help on what they should do. A great way to make sure your pharmacy is a success is to get on the online directory of one of these websites. They generate plenty of traffic which means that plenty of people will be seeing your pharmacy daily.

How can you go about getting onto these directories? Simply get in touch with them and tell them about your business. They will take some time to deem if you are reputable or not. Once they have done so, they will come up with a plan on how to get you listed on their website. This will often include a fee or a monthly payment but it is well worth the investment to guarantee the success of your pharmacy.

Endorsements From Doctors

People are wary of buying drugs and medicines online. Even though it comes with a tamper-proof seal, people question if they have received the correct medication or if it was altered in any way. One of the ways to combat this is to get in touch with doctors and get their approval and patients.

Doctors are the ones who hand out prescriptions that have to be filled by the pharmacy. By talking to a doctor, you could possibly convince them to use your website as their pharmacy for their patients. With their doctor endorsing it, patients will be that much more likely to use your website and acquire their medications from it.

Don’t just stop at one or two doctors either. The more doctors that you can get to give you an endorsement means the more patients and prescriptions that you will have to fill. Some doctors will ask for a cut or a fee for choosing you so it becomes a game of whether or not it is worth it. The more doctors that you can get on board with your pharmacy, the more success you are going to have.

Search Engine Optimization

With any business, the more people who see it, the better the chances of you making a sale. Search engine optimization or SEO is a tool employed by many companies that allows them to show up much sooner in search engines when keywords are searched. When a website is first created, it does not rank, meaning it will not show up in a search engine.

Taking the necessary steps and hiring a company to boost you will result in great things for your business. It will allow you to rank on search engines while also exponentially increasing the number of people who view your site. Typically speaking in the medical world, people who go to online pharmacies are looking to purchase right away, not shop around for what is available. Therefore, the more people you can attract over to your website, the more successful you will be.

Offer Slightly Lower Prices

Medicine and drug prices are already incredibly escalated for anyone needing them. If you want to build a reliable customer base and find success, you are going to have to find a way to steal customers from regular pharmacies. The best way you can do this is by offering prices that are lower than your competitors.

When people see this, they will be much more willing to give you a try and order a prescription or two. They can save money and not even have to worry about leaving the house. Do you really want to leave the house to get medicine if you are sick?

Another thing to consider is providing free shipping to your customers. Shipping costs often scare people away and cause them to stick to physical retail places. By offering free shipping, you can get away from all of that and keep your customers interested in your pharmacy.

By using all of these tips, you are sure to get your pharmacy the exposure and success that it needs to run. Remember to be patient as starting a business does take time and getting a reliable customer base can take even longer. Stick with it and do your best to stay in touch with the medical world. When do you plan on opening your pharmacy?

RHÖN-KLINIKUM AG and Siemens Healthineers have signed a partnership agreement under which RHÖN-KLINIKUM Campus Bad Neustadt acquires the status of Siemens Healthineers European Center of Reference for Cardiovascular Medicine. This gives both national and international customers of Siemens Healthineers the opportunity to learn from the medical experts in Bad Neustadt how state-of-the-art imaging systems and solutions can be used more efficiently in diagnostics, therapy, and aftercare for patients with cardiovascular diseases.

The certificate will be awarded during the internal event “Networking and interaction between cardiology, heart surgery, radiology, and rehabilitation” at the RHÖN-KLINIKUM Campus Bad Neustadt on September 24.

Multi-sector collaboration for the patient’s benefit

Being named as an international Center of Reference for cardiovascular medicine is just one acknowledgment of the hospital’s approach to integrating treatment for heart-failure patients across medical specializations. In May 2020, the project “Trans-sectoral treatment according to requirements of patients with cardiac insufficiency and development of an alternative remuneration model” (“sekTOR-HF”), initiated by RHÖN-KLINIKUM AG, also received a project grant for a total of 42 months from the Innovations Committee in the Federal Joint Committee (G-BA).

sekTOR-HF is a collaborative project between medical and scientific partners in the focal regions of Rhön-Grabfeld (Bavaria) and Marburg-Biedenkopf (Hesse). “We developed this project on the basis of our RHÖN Campus concept, which has enabled us to provide multi-sector healthcare for our patients for a number of years, including the use of digital networking,” explains Professor Bernd Griewing, Member of the Managing Board of RHÖN-KLINIKUM AG. “With sekTOR-HF, we’re aiming to break down real-world sector boundaries and be able to think and work as part of regional networks. Otherwise the system simply won’t work in the future, especially in rural regions.” Professor Sebastian Kerber, head of Cardiology I at RHÖN-KLINIKUM Campus Bad Neustadt, adds: “There are particular challenges associated with handling, diagnosing, and treating patients with heart failure. Only differential diagnosis and personalized heart-failure therapy can enable reasonably lengthy survival times and improve quality of life.”

Long-term cooperation

“Many years of highly successful cooperation link us with RHÖN-KLINIKUM Campus Bad Neustadt,” observes Dr. Bernd Ohnesorge, head of the Europe, Middle East and Africa (EMEA) Region at Siemens Healthineers. “For example, we helped the hospital to successfully integrate multimodal therapy concepts in diagnostic imaging and image-guided therapy into its clinical routine. In the future, we’ll also function as a full strategic partner to RHÖN-KLINIKUM Campus Bad Neustadt to develop innovative models to bolster healthcare at a regional level. All of this confirms my view that RHÖN-KLINIKUM Campus Bad Neustadt is ideally suited to be a European Center of Reference for cardiovascular medicine.”

The experts in cardiovascular care at Siemens Healthineers view themselves mainly as advisers who offer end-to-end solutions intended to help restructure healthcare in cardiovascular medicine. Their guiding principles are the expansion of precision medicine, improving the patient experience, and digitalization of the healthcare sector.

“For me, the crucial factor is that Siemens Healthineers not only manufactures devices, they also help us develop innovations perfectly suited to ensuring the best possible diagnostic and treatment workflows at our hospital,” says Dr. Lukas Lehmkuhl, head of Diagnostic Radiology at RHÖN-KLINIKUM Campus Bad Neustadt. “We’re looking forward to being able to welcome internationally renowned cardiologists, radiologists, and surgeons to our facility to show them our approach and our innovations.”

“RHÖN-KLINIKUM Campus Bad Neustadt provides comprehensive care for patients with cardiovascular diseases and pursues an integral treatment strategy covering the entire clinical patient pathway,” says Doris Pommi, General Manager Global Cardiovascular Care at Siemens Healthineers. “That makes this hospital especially well-suited to serve as a reference site for cardiovascular solutions. Integrated innovations and concepts that optimize patient therapy in order to achieve better treatment results are our common goals.”

History of successful collaboration between Siemens Healthineers and RHÖN-KLINIKUM Campus Bad Neustadt

Clinical and scientific collaboration with RHÖN-KLINIKUM Campus Bad Neustadt began as early as 2001 with the efficient integration of various methods of cardiovascular imaging in order to improve diagnostics and image-guided therapy in cardiovascular healthcare. In addition, imaging and therapeutic intervention became increasingly closely linked with the refinement of the clinical pathway concept, thanks to the integration of diagnostic imaging modalities. Radiology and interventional cardiology grew together to form a multimodal pathway concept for patient-centered imaging. “Now, with more than 1,500 MRI and about 600 to 800 CT scans each year in cardiac diagnostics alone, RHÖN-KLINIKUM Campus Bad Neustadt has been one of the first users of this multimodal concept,” says Professor Thomas Deneke, head of Cardiology II at RHÖN-KLINIKUM Campus Bad Neustadt.

In 2010, Siemens Healthineers and RHÖN-KLINIKUM Campus Bad Neustadt worked together successfully on extensive consulting approaches to systematically assess and improve hospital operation and on clinical processes to improve results for selected diseases. At the time, RHÖN-KLINIKUM Campus Bad Neustadt provided elements of best practices for the standardized management of acute coronary syndrome (ACS) and heart failure – for example, the CardioAngel project – and established one of the first special wards for patients in the advanced stages of heart failure.

Fields for future collaboration

Both partners want to continue to encourage the sharing of knowledge and experience in cardiology in the future. One example is a clinical training program for physicians and the medical assistance professions. In the future, they hope to work together to improve clinical workflows and continue to develop innovative treatment strategies for non-invasive and invasive cardiology. This will include defining diagnostic and treatment pathways that will make patient care even more efficient and personalized. In direct interaction with various Siemens Healthineers Business Areas, RHÖN-KLINIKUM Campus Bad Neustadt will also support the development of future processes and technologies. Their shared insights will flow into future developments from Siemens Healthineers.

About RHÖN-KLINIKUM Campus Bad Neustadt
RHÖN-KLINIKUM Campus Bad Neustadt, one of five locations operated by RHÖN-KLINIKUM AG, provides multi-sector medical care in rural areas. At its hospital premises,the campus brings together outpatient and inpatient services with a wealth of medical and preventive care services that weren’t previously co-located: Self-employed specialists and clinics representing diverse fields like cardiac medicine, orthopedic surgery, and neurology work hand-in-hand with nursing and rehabilitation services. An essential element in this setting is the digital networking of all the players involved in the treatment process using innovative IT solutions and communication systems. The more than 2,800 employees at the campus treat about 78,000 patients every year.

About Siemens Healthineers
Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services.

In fiscal 2018, which ended on September 30, 2018, Siemens Healthineers generated revenue of €13.4 billion and adjusted profit of €2.3 billion and has about 50,000 employees worldwide.

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Slip and fall accidents can occur relatively anywhere. As a product of the environment and the lack of one’s own personal awareness, slip and fall accidents might infer that their only liability is yourself, but that is often not the case. When you are visiting an area or a private property maintained by someone else, you may be able to seek injury compensation in response to their failure to maintain a safe environment if an accident has occurred. A premises liability claim can then be issued against the property owner, landlord, or figure of authority to accurately compensate for lost workdays and high medical costs. If you wish to prove and hold someone at fault, you need to write a slip and fall incident report. If you are looking to defend your claim in the court of law, consider Fresno Slip and Fall Accident Lawyers.

A slip and fall incident report includes all the necessary information about your accident. It is a mandatory report needed to facilitate the ability of compensation for your injuries.

Report framework

Before you contact an attorney, it is crucial that you have a proper outline detailing the incident that you can use for reference. It is easy to find fault in a slip and fall case, but backing it up with evidence requires that you recount and note the details of the incident as quickly as possible so that crucial factual items of note are not forgotten. Finding a report outline example online is quite easy – you should choose one that relates best to your situation, and add to it depending on the complexity of the case. Make sure to consider the statute of limitations if you wish to file a lawsuit or receive injury compensation. Act fast contact the property owner or person in charge of the maintenance to see if the issue can be rectified in a civil manner.

Alternatively, if you have suffered from an injury in a business location, the Occupational Safety and Health Administration (OSHA) necessitates that all businesses require proper slip and fall incident reports that you can fill out at the ready. While this makes the incident report much more accessible, it is, however, still essential that the incident is reported to an attorney if you wish to seek proper legal action.

Content and prerequisites

Slip and fall cases are in no way a jovial manner. They comprise over 8 million hospital visits annually, totaling to one in five of every annual hospital visit. Slip and fall cases are a question of when, not if. Their severity increases exponentially by age, and are the leading cause of missed workdays.

When writing a slip and fall report:

• Recount the details of the incident (date, time, location, activity in question, cause of fall, etc.);
• Inspect the location of the fall, including environmental conditions and any other special circumstances involving the accident;
• Retrieve evidence of injuries (photos, hospital reports, etc.), including medical expenses, income losses, and other incidents of suffering;
• Inform witnesses, follow up on their narrative;

These are the main details of a slip and fall incident report, but your attorney may ask for you to provide additional information depending on the circumstance of the accident. For example, is important to note whether you were visiting the property or area in question legally, and were allowed to be there in the first place.

Most importantly, you should remember that a slip and fall case is necessary to be resolved so that the environment is better prepared and safer for other people and that your injuries are fairly compensated for by the person at fault of the accident.