Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Speed control circuit board issue that may cause the motor to be unresponsive to the user.
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
Solventum purification and filtration portfolio expected to be highly complementary with Thermo Fisher’s bioproduction business, strengthening the company in the high growth bioprocessing market.
Teleflex to create a new, independent publicly traded company consisting of its Urology, Acute Care, and OEM businesses. Remaining units and recently announced acquisition expected to remain.
The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would represent roughly 10% of the program’s total staffing.
Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her conviction in a blood-testing hoax that brought her fleeting fame and fortune.
On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to raise awareness about cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors. These medical devices are used in health care and home settings for displaying information, such as the vital signs of a patient, including temperature, heartbeat, and blood pressure.
Advancements in cardiac care and novel therapies are transforming cardiac medical devices, providing new solutions for millions affected by heart disease globally.
