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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...

Brainomix Achieves Breakthrough with FDA Clearance of e-Lung AI Software

Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, is proud to announce the FDA clearance of its latest product,...

Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm

Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling...

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