Cerebral cavernous malformation (CCM) patients treated with oral drug, REC-994, showed reduction in total cerebral and brainstem lesion volume.

US-based health technology company ... This system is set to benefit from Anumana's ECG-AI LEF algorithm, which is approved by the US Food and Drug Administration (FDA) and uses routine 12-lead ...

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf ... believe the same will hold true when the tool is an AI/ML based algorithm that may well need approval in its own right.

Tempus AI (TEM) announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians ...

Medtech company DermaSensor has claimed FDA approval for a handheld device ... that measures the physical properties of tissue with an AI algorithm to interpret the data. It can deliver a result ...

Chief R&D and commercial officer Najat Khan, PhD, tells GEN Edge the company aims to improve design of studies, accelerate enrollment, and enhance evidence generation.

HLB announced on the 14th that the last hurdle for U.S. Food and Drug Administration (FDA) approval ... (AI) corporation AirsMedical announced that it has signed a supply contract for the AI-based ...

To mitigate these problems, FDA proposes a risk-based credibility assessment ... Separately, wary of data drift and other post-approval changes in an AI model, FDA emphasizes the importance ...

A routine tech checkup revealed the algorithm decayed ... some 20 health-focused AI startups on track to make $10 million in revenue each in a year. The FDA has approved nearly a thousand ...

Eko sells a range of digital stethoscopes and already has two FDA-approved AI algorithms for other cardiac features, one for atrial fibrillation (AF) and another for structural murmurs associated ...

Wen Shuhao helped speed up the development of Pfizer’s Covid oral drug, Paxlovid. Now the chairman of Xtalpi wants to help ...