The EPA's sole function is to protect Americans from environmental health threats, and yet again and again it backs ...

On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. This dynamic which scrutinized ...

What regulatory shifts in AI, cybersecurity, digital submissions, and capital strategy mean for your success in ...

Medical device cyber challenges are among the most complex for manufacturers and healthcare delivery organizations for a variety of reasons, but there are some ...

Advanced AEDs, sophisticated mechanical CPR devices and automated tourniquets put firefighter/paramedics and EMTs in position ...

Congress should enact legislation to require the Centers for Medicare and Medicaid Services to evaluate transitioning to a single modern procedure coding system to eliminate excess costs and lower ...

ASX health imaging firms see AI as opportunity, not threat, with growth potential intact despite recent sell down in software stocks.

International experts validate Singapore device regulation system. Singapore's Health Sciences Authority (HSA) reached Maturity Level 4 (ML4) for medical device regulation, making it the first World ...

It’s not yet clear what’s in store for Endologix’s Sonoma County facility amid plans to shut down a Silicon Valley plant.

Modern conveyance systems help medtech manufacturers achieve flexibility, compliance, and integration in smart factories.

From the labs of Galway to the research hubs of Dublin and Cork, a new generation of start-ups is transforming how we diagnose, treat and manage health conditions.