Reposted from Matrix Requirements (August 24, 2024) Leveraging big data in medical device software is transforming the medtech industry, driving significant advancements in patient care and operational efficiency. By harnessing the power of big data, medical devices now offer real-time monitoring, predictive analytics, and personalized treatment...
The medtech industry continuously strives to deliver innovations that can enhance patient outcomes and improve their quality of life. But what happens if someone can’t access a medical device or diagnostic that can help them? Nearly 80% of U.S. counties are classified as healthcare deserts where obtaining proper care is challenging.1 To address this,...
Fifteen years ago, medical device reimbursement in Japan normally created a very profitable business for many device companies. For example, at that time, if the device company had 10% of its sales in Japan, it might have had 15% of its profits coming from Japan due to relatively high device reimbursement prices. Unfortunately, those days are over....
Remote healthcare has quickly evolved from an idea in the minds of providers to the new standard defining modern healthcare. Patient monitoring has experienced a journey that is redefining flexibility, granting patients more freedom, and allowing for a new level of care previously unattainable. Basic monitoring has humble beginnings – from manual...
AI has a transformative role to play in healthcare, from improving diagnosis and care planning, to addressing conditions that have been historically difficult to treat. The integration of AI into healthcare is already well underway. Notable and increasing adoption of AI technologies within the industry is evident in: Medical imaging – diagnosis...
Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical Device Regulation (EU MDR) is mandatory. These reports serve as documented evidence to establish that a medical device meets the required safety...