MobiHealthNews

FDA clears Current Health's remote monitoring platform for home use

In February, Edinburgh, Scotland-based Current Health (formerly snap40) received FDA clearance for clinical use of its artificial intelligence-enabled device and platform for remote patient monitoring ...

Israel's Pulsenmore gains FDA approval for at-home ultrasound device

Pulsenmore’s FDA-approved home ultrasound device allows pregnant women to perform scans from home, revolutionizing pregnancy ...
MobiHealthNews

FDA approves MedApps wireless remote monitoring

The FDA announced today that wireless remote monitoring system HealthPAL, which MedApss developed, has received 510(k) clearance, according to an email from the company. HealthPAL is the small, ...
WNCT

Sleepiz AG Lands FDA 510(k) Clearance for Contactless Remote Patient Monitoring Device Measuring Vital Signs

MINNEAPOLIS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Sleepiz, a Zurich-based medical technology company providing contactless bedside patient monitoring, today announces the FDA Class II 510(k) clearance of ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Forbes

Are The FDA’s New Regulations On Medical Devices Making A Difference?

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the Food and Drug Administration (FDA) took a more active approach to medical ...
Hosted on MSN

FDA seeks industry feedback on AI medical device safety monitoring

The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...