Vinay Prasad’s departure marks another high-profile leadership change at the FDA, which is going through a period of significant change.

LifeVac has received De Novo classification from the US FDA for its suction anti-choking device under 21 CFR 874.5400.

SmartHeart AI is a workflow planning solution designed to facilitate the application of tools within Philips’ broader cardiac MR suite.

Nabta Health, the Dubai-based hybrid healthcare company positions women not as a niche market but as the starting point for a ...

Airiver Medical has secured the US FDA breakthrough device designation for its pulmonary DCB intended for the treatment of ...

Philips has unveiled its next-generation radiology CT system, Rembra, to address the challenges faced by acute and high-demand imaging settings.

Droplet Biosciences has reported a reduction in genomic analysis turnaround time for residual cancer detection by adopting GPU-accelerated workflows using NVIDIA Parabricks software.

RadNet will now offer AI-driven services across screening, detection, interpretation and follow-up across multiple disease areas.

The proposed IPO could see MiniMed offer 28m shares as the company looks to reach profitability independently of Medtronic.

Cognita has received the FDA breakthrough device designation for the Chest X-Ray (CXR) model across multiple critical indications.

PathAI has received the US FDA breakthrough device designation for PathAssist Derm, an AI-powered dermatopathology workflow solution.

Polares will use the funds to support MRace’s global clinical development programme for the treatment of mitral regurgitation ...