AI streamlines medtech supply chains, but only 45% of physicians embrace clinical AI integration, highlighting a trust gap in ...

Medtronic will acquire SPR Therapeutics for $650 million, adding the FDA-cleared SPRINT PNS System for temporary PNS to its ...

CDRH fees doubled repeatedly. Is regulatory expansion justified? One observer says no. Breakthrough devices and TAP programs ...

Endologix has acquired Surmodics' Pounce System, a platform for non-surgical peripheral arterial thrombi removal, expanding ...

EmStop has initiated the CAPTURE-2 IDE clinical trial to support the firm’s mission to develop an embolic protection system ...

The clearance follows Glooko and mylife Diabetes Care announcing an agreement to further expand their partnership.

Medical device manufacturers face mounting pressures—volatile supply chains, rising costs, intensifying competition, and complex regulations. Traditional ERP systems, designed merely to record past ...

What’s the next CGM step change, and how is Dexcom going to deliver it? That’s one of the fundamental questions Jake Leach has been asked since stepping into the role of CEO at Dexcom. “I want to make ...

The DoJ secured record-breaking False Claims Act recoveries of $6.8 billion in fiscal year 2025, with $76 million from the ...

Naomi Schwartz, VP of Regulatory Strategy for Medcrypt, talks about the company's offerings to help with cybersecurity.