Fierce Biotech

Prasad, Makary unveil new FDA path for accelerating custom gene editing therapies

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory ...
Medical Device and Diagnostic Industry (MD+DI)

Software Version Control for Medical Devices: Turning Traceability into Compliance Confidence

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...

IMDX Reports Q3 2025 Results and Progress Toward 2026 Commercial Launch

On track to submit GraftAssureDx™ for FDA review by year-endOn track for commitment to have 20 transplant centers globally ...
Business Wire

Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care

SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ...

Pharma & Biotech Computerized Systems Validation, Data Integrity & Cloud Computing Training Seminar (Dec 9th - Dec 10th, 2025)

Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ensuring compliance with FDA ...