Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
Dr. Eckhard Alt, MD, PhD, Executive Chairman of InGeneron, Inc. stated that receipt of MDR certification marks an important milestone in the Company's continued ability to provide cell therapy medical ...
The European Union's Medical Device Regulation (EU MDR) has become much more sophisticated and specific. Since taking effect in May 2017 the EU MDR includes more challenging protocols, including new ...
A recent study led by researchers at the Yale School of Medicine and Harvard Medical School found that a loophole in existing regulation has allowed manufacturers to acquire U.S. Food and Drug ...
On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...
January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
A populous nation that also draws medical tourism, Turkey presents a huge opportunity for medical device companies. But regulations and reimbursement remain a challenge. Özge At?lgan Karakulak and ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results