FDA/​Regulatory

FDA has launched an innovation challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder — a serious health condition that can be a...

An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It will...

ASTM International’s new committee on exoskeletons and exosuits (F48) held its first meeting Feb. 13–14 in Philadelphia, PA, near the organization’s global headquarters. The need for technical standards has grown alongside the rising use of exoskeletons in manufacturing,...

Properly prepared test articles are critical for accurate biocompatibility testing. As a sponsor of a medical device, it is imperative for medical device manufacturers to understand what to do to ensure a successful test of a proposed medical device.

The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute.

Incoming AdvaMed chairman Nadim Yared will continue AdvaMed’s drive to ensure a permanent repeal of the medical device excise tax, calling it his “highest priority” heading into his term as chairman. Yared, who is president and CEO of CVRx, spoke at a press conference in April.

The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.

Researchers from the U.S. Army Institute of Surgical Research collaborated with scientists and engineers at the University of Colorado and Flashback Technologies, Inc., to develop an algorithm, the Compensatory Reserve Index (CRI), to detect when a patient experiences hemorrhagic shock, a leading...

The U.S. Department of Veteran Affairs (VA), Washington, DC, and UL (Underwriters Laboratories), Northbrook, IL, a global safety science organization, have signed a Cooperative Research and Development Agreement (CRADA) for current and emerging medical devices cybersecurity standards...