medtechintelligence4h
FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
medtechintelligence4h
FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+
Max Mobility/Permobil is recalling the SpeedControl Dial component used with the SmartDrive MX2+ Power Assist Device due to a ...
medtechintelligence4h
FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
medtechintelligence5h
Thermo Fisher Scientific to Acquire Purification and Filtration Business
Solventum purification and filtration portfolio expected to be highly complementary with Thermo Fisher’s bioproduction ...
medtechintelligence1d
Teleflex announces plan to separate its businesses
Teleflex to create a new, independent publicly traded company consisting of its Urology, Acute Care, and OEM businesses.
medtechintelligence3d
Predictive Quality for Medical Devices
September 26, 2024 – 1:00 pm – 2:00 pm ...
medtechintelligence3d
FDA’s Revolving Door? The Agency moves to rehire CDRH staffers fired days earlier
The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, ...
medtechintelligence5d
Elizabeth Holmes’s Appeal to Overturn Conviction Is Denied
Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her ...
medtechintelligence10d
Sweeping FDA Cuts Hit CDRH Staffer’s Inboxes
On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. "Unfortunately, ...
medtechintelligence11d
Quality/Regulatory
An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of ...