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ImmersiveTouch Wins FDA Clearance for Breakthrough Augmented Reality Surgical System

ImmersiveTouch Inc., a leading digital surgery company, announced that its groundbreaking augmented reality (AR) technology platform, ImmersiveAR, has received 510(k) clearance for clinical use...

Healthcare

CMS Awards Tempus With Advanced Diagnostic Laboratory Test (ADLT) Status for its xT CDx Test

Tempus AI, Inc., a leader in artificial intelligence and precision medicine, announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced...

Healthcare

Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib

Tempus AI, Inc., a leader in artificial intelligence and precision medicine, announced it has received 510(k) clearance from the U.S. Food and Drug Administration...

Healthcare

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...

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