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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...

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...

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...

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...

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...

Avenda Health Deploys AI Cancer Imaging Technology at Kasraeian Urology, Improving Local Access to Cutting Edge Prostate Cancer Care

Avenda Health, an AI healthcare company and Kasraeian Urology, a Jacksonville-based practice are bringing AI-powered imaging technology, Unfold AI, to residents throughout the community. By incorporating...

DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA).

DentalMonitoring, the leader in AI-powered remote monitoring for orthodontic treatment, has received De Novo approval from the U.S. Food and Drug Administration (FDA) for...

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