Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold the ...

Draft guidelines from the European Commission aim to assist companies in determining whether their products, including ...

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...

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 ...

Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...

Lawrence Tallon, CEO of the MHRA, discusses the agency's initiatives to advance the UK's regulatory protocols for medical devices.

The medtech industry will likely have more time than previously expected to adapt to new medical device regulations for the Great Britain market. The Medicines and Healthcare products Regulatory ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...