The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class ...

AcuityMD has raised $80 million to add artificial intelligence features to its platform for medical device commercial teams.

Apple can continue selling redesigned Apple Watches with a blood oxygen feature after the International Trade Commission ...

The company, whose shares climbed nearly 8% Wednesday morning, also said a recent cyber incident has been contained and did ...

CEO Mike Mahoney told investors that the lowered forecast reflects challenges for several businesses, including ...

Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial ...

The finding informed research at Nanjing Medical University, where physicians initiated a first-in-human trial of PADN in ...

New glucose sensors and a partnership with Abbott are expected to drive sales growth at MiniMed, BTIG analyst Marie Thibault ...

The Centers for Medicare and Medicaid Services said it developed concerns about the limited evaluation process for the ...

Amplitude’s intravascular lithotripsy technology could emerge as a challenger to Shockwave IVL, Leerink Partners analyst Mike ...

GE HealthCare and Siemens Healthineers are also targeting the premium CT space. Siemens Healthineers received 510 (k) ...

The German parent, which is giving up its majority stake in Siemens Healthineers, said preparations for the transaction are ...