Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...

Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers ...

ROi CPS, LLC, is recalling newborn kits after receiving an Urgent Field Safety Notice for a kit component from the supplier Mercury Medical. The affected component is the Neo-Tee T-Piece resuscitator, ...

Max Mobility/Permobil is recalling the SpeedControl Dial component used with the SmartDrive MX2+ Power Assist Device due to a circuit board issue that may cause the motor to be unresponsive to the ...

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. Teleflex ...

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.

Biosense Webster updated the use instructions for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack (TIA or “mini stroke”) seen in the first 132 procedures after ...