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AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

AliveCor, the global leader in AI-powered cardiology, announced the U.S. Food & Drug Administration (FDA) clearance and commercial launch of KAI™ 12L AI technology...

Healthcare

Roche receives FDA clearance on its digital pathology solution for diagnostic use

Roche announced that its whole-slide imaging system, the Roche Digital Pathology Dx (VENTANA DP 200), has received 510(k) clearance from the United States Food...

Automation in AI

Element Announces RegNav, its First AI-Powered Platform Promoting Safer and More Reliable Medical Device Development

Element Materials Technology (Element), a leading global provider of testing, inspection, and certification (TIC) services, announced the launch of Element RegNav (RegNav), its first...

Healthcare

Avicenna.AI secures FDA clearance for AI detection of vertebral compression fractures

Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures. Avicenna.AI, a leading medical imaging AI company, has...

Healthcare

Sware Raises $6M to Accelerate Life Sciences Innovation by Automating FDA-Mandated Software Validation

First Analysis, LRVHealth and New Stack Ventures Fund Series B to Erase Validation Debt and Empower Fast, Efficient and Safe Life Sciences Innovation Sware, provider...

Healthcare

GE HealthCare Tops List for Third Year in a Row with Highest Number of AI-Enabled Medical Device Authorizations

GE HealthCare has topped a U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI) enabled medical devices for the third year in...

Healthcare

Harpreet Singh, MD, Departs the FDA and Joins Precision For Medicine as Chief Medical Officer

Dr. Singh brings a track record of leadership and innovation from the FDA's Oncology Center of Excellence, with deep expertise in precision medicine and...

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