Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
CounterPunch

The FDA Fails to Protect Americans from the Medical Device Industry

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability Office (GAO) report only strengthens that conclusion.
Reuters

Medical device maker Becton Dickinson sued over alleged hernia mesh monopoly

WASHINGTON, Dec 22 (Reuters) - Becton Dickinson (BDX.N), opens new tab has been sued by a rival medical device manufacturer for allegedly thwarting competition in the U.S. market for surgical hernia ...
MedPage Today

FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, GAO Report Says

This story was originally published by ProPublica. The FDA rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it's sometimes unable to make sure ...
Crain's Chicago Business

Durbin, Schakowsky take aim at medical device recalls

Illinois Sen. Dick Durbin and Rep. Jan Schakowsky want an electronic format for medical device makers to quickly and transparently report recall information to federal regulators to improve what they ...
Healthcare Dive

FDA needs more staff, authority to oversee device recalls, watchdog finds

The Food and Drug Administration lacks adequate staffing to oversee medical device recalls, according to a report released Friday by the U.S. Government Accountability Office. The report, which ...
FierceBiotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...
ProPublica

The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, Watchdog Report Finds

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration rarely uses its authority to ...
MM&M

The FDA rarely forces manufacturers to recall dangerous medical devices, watchdog report finds

This article originally appeared on ProPublica. The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it’s sometimes ...
mccormick.northwestern.edu

QSI-TEAMS to Fast-Track Medical Device Development

At a time when medical technology breakthroughs often stall long before reaching patients, Northwestern University’s Querrey Simpson Institute for Bioelectronics (QSIB) has become a striking exception ...
CNBC

An under-the-radar medical device stock with 20% upside, according to the charts

Every December one of my annual exercises is to look at which sectors have underperformed and are likely to turn things around. This year the popular answer has been health care and there's reason to ...