Dangerous medical implants and devices

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...
Medical Device and Diagnostic Industry (MD+DI)

Medical Device Companies Must Navigate Historic FDA Rule Change

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Gastroenterology Advisor

Incorrect Readings Prompt Recall of Certain Abbott Glucose Sensors

Abbott Diabetes Care is recalling certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to falsely low glucose readings.
Fierce Biotech

FDA slaps highest-risk recall notice on J&J Medtech Cerepak detachable coils

The FDA has flagged J&J Medtech’s recall of its Cerepak detachable coils as Class I in the wake of one death and four serious ...

Surgical Staplers Market Size to Reach USD 10.87 Billion by 2033, Driven by Rising Surgical Volumes & Minimally Invasive Procedure Adoption – SNS Insider

Technological advancements in stapling systems, increasing preference for minimally invasive surgeries, and expanding hospital infrastructure accelerate global market growth.Austin, United States, Feb ...

Global Medical Radiation Detection Devices Market to Increase at a Steady Growth Rate of ~7% by 2032 | DelveInsight

The growing global incidence of cancer is a major factor driving demand for medical radiation detection devices. Additionally, the increasing use of diagnostic imaging technologies such as X-rays, CT ...
Assembly Magazine

Micro-Scale Leak Testing of Medical Devices

Given the highly infectious nature of the COVID pathogen, tests for the virus had to be quick, reliable and safe. The test ...
MarketWatch

ICU Medical Recalls IV Gravity Burette Set, FDA Says

ICU Medical is recalling its IV Gravity Burette Set which could cause serious injury or even death, according to U.S. health regulators. The IV Gravity Burette Set is a medical device used to give ...
Bloomberg L.P.

Bolsonaro Undergoes Medical Procedure to Treat Severe Hiccups

Brazil’s former president, Jair Bolsonaro, underwent a medical procedure on Saturday afternoon at a hospital in Brasília to treat a bout of persistent hiccups. The intervention, described as ...
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 ...