The FDA’s draft MDUFA VI agreement proposes new, faster pre-submission track, changes to de novo communication and more.

An industrial X-ray CT scan shows the internal design of the ResMed AirSense 10 AutoSet CPAP device used by millions of sleep ...

Brian Miller shares how he built his career, what it was like at Intuitive as the device developer grew, and advice for ...

With an initial indication for type 2 diabetes, SaMD developer UpDoc says its platform is designed to support doctors, not ...

The FDA has flagged three third-party labs that submitted device testing data that may have falsified, invalid or copied from ...

XCath might have a head start after completing the first remote mechanical thrombectomy on a patient over 120 miles away.

In this issue of Medical Design & Outsourcing, we focus on the tech advances and device innovators making stroke telesurgery ...

Teleflex reported 2025 compensation for top executives, including two who left after the medtech CDMO sold off some big ...

"What impressed me about Ketryx was how they envisioned using AI to build safer products faster," Hawkins said.

Led by CEO Harry Rowland, VahatiCor is developing the A-Flux coronary sinus reducer implant for coronary microvascular dysfunction.

Ford, you may have been spending more time than most car owners at the dealership getting repairs on the automaker's dime.

BTIG analyst Ryan Zimmerman said while the increase in approvals is promising, longer decision times may have financial implications.