Singular Health strengthens US commercial strategy on being granted FDA 510(k) clearance for its imaging platform 3DICOM MD® ...

CES attendees saw health-tracking gadgets making bold promises: toothbrushes detecting diabetes, mirrors assessing 20-year ...

The FDA has cleared a mobile application that will connect with a next-generation multiple daily injection automated insulin ...

Craters & Freighters strengthens compliant dangerous goods shipping across 30+ locations using DGIS software to ...

Vektor Medical, a medical technology company transforming cardiac arrhythmia care, announced key milestones achieved in 2025, a year defined by progress, innovation, and growth. Vektor's flagship ...

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

A new proposal in JAMA Internal Medicine suggests that the FDA should create an approval pathway for medical AI tools that parallels how physicians are trained and licensed.

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...