FDA Inspection of a Philips Facility Raises Red Flags

The agency's findings suggest that Philips Respironics has known about the potential foam degradation issues for years.

What Were the Top Medtech Startups in 2021?

These medical device startups are hoping to transform healthcare, and they've had a pretty good year. What do you think?

A Rumored Acquisition Could Shake up Orthopedics

Globus Medical could be looking into acquiring Nuvasive, according to a Reuters report.

FDA Is Back in the Driver’s Seat with LDTs

HHS just withdrew a Trump Administration-established policy limiting FDA’s ability to regulate laboratory-developed tests.

S+N’s New Center to Push Innovation in Surgical Robotics

The London-based company said the center would be based in Munich, Germany.

Medtronic Leadless Pacemaker Linked to Major Complication Risk

Although cardiac perforations are rare, FDA says the risk of major complications following cardiac perforation may be higher in patients who receive a Medtronic Micra leadless pacing system.

When They Go High We Go Low: Using Low Energy to Treat AFib

Cardialen has won a nod from FDA for an IDE to begin a clinical trial of its Multipulse therapy.