Regulatory expert Jessica Schafersman explains why device startups must integrate FDA compliance from concept phase, not ...

Vital Signals has launched Signal Ring, the first wearable ring designed specifically for continuous, calibration-free blood ...

Dinneen breaks down the biggest networking mistake that medtech professionals make — and how to fix it. Below is a transcript ...

Intuitive Surgical's greatest headwinds stem not from competitors in the surgical robotics market but from the rising use of ...

Aziz Mottiwala becomes RxSight CEO July 20 amid commercial challenges. The move follows the $200M Alcon deal for adjustable ...

DePuy Synthes has acquired Expanding Innovations, a startup specializing in expandable implant technology for spine surgeries ...

Vicarious Surgical’s board is asking shareholders to approve a plan that would dissolve the financially strapped company, ...

A third-party randomized trial from King’s College London is being cited as the reason Johnson & Johnson’s Impella usage has ...

BTIG has reiterated its Buy rating for iRhythm Technologies following the CMS CY2027 Physician Fee Schedule proposal.

In early July, W. L. Gore & Associates announced that FDA had approved updated labeling for its GORE EXCLUDER AAA Endoprosthesis and GORE EXCLUDER Conformable AAA Endoprosthesis, removing a ...

ISO 10993-1 is the standard that outlines the framework for the biological evaluation of medical devices. It establishes the regulatory requirements for assessing potential risks arising from a device ...