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

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

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

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

For medical device companies, the harder truth is that almost nothing that slowed your last 510(k) had anything to do with ...

It's no secret that the IVL space has been red-hot over the last several years, with more and more big-name players wanting a piece of the pie. What began as a niche calcium modification technology ...

As competitors rapidly adopt AI, the choice is clear: embrace intelligent automation now or risk falling irreversibly behind ...

Shockwave Medical's CMO discusses the C2 Aero launch, why the company is defining what qualifies as true IVL, and J&J's R&D ...

BostonSci secures rights to acquire MiRus' SIEGEL TAVR system with $1.5B equity stake and potential buyout, marking its 3rd ...

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

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 ...