As Valentine’s Day gifting trends expand beyond traditional items, wellness and self-care devices designed specifically ...

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices ...

FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

The FDA clearance of GE HealthCare’s next-generation Signa products aligns with the company’s multi-year strategy to differentiate its MRI portfolio.

While Mexicos health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has ...

Rick Abrmason, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret ...

Users may receive an error code either due to a test strip error or a very high blood glucose event, Trividia Health said.

Approximately 10.5 million Americans have atrial fibrillation (AFib), a condition that causes an irregular, often too fast, heartbeat. AFib increases the risk of stroke four to five times more than ...

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Called Stealth AXiS, the surgical system builds on Medtronic’s Mazor robotic platform, as the medical device maker takes ...