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

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

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

Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high ...

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.

The Associated Press reported barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back ...

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 ...

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 ...