finanzen.at

EQS-News: REMSleep Receives Expanded FDA 510(k) Clearance for DeltaWave Nasal Pillow System

The expanded 510 (k) clearance is publicly available in the FDA's 510 (k) Premarket Notification database under device number K253939.
Business Wire

Neurescue's Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage ...

COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S.
Healio

FDA grants 510(k) clearance to AI-powered delirium screening device

Please provide your email address to receive an email when new articles are posted on . The device is the first to gain FDA clearance to monitor delirium. The device’s algorithm was validated with ...
Becker's ASC

CurveBeam Receives FDA 510(k) Approval for the pedCAT 3D Foot and Ankle Scanner

CurveBeam has announced it has received FDA 510(k) approval for pedCAT, an in-office 3D foot and ankle scanner, according to a news release from CurveBeam. pedCAT uses cone Beam Computed Tomography ...
Becker's ASC

Food and Drug Law Institute Report Says FDA Needs to Reform 510(k) Process

The Food and Drug Law Institute has released a report that urges the FDA to reform the 510(k) approval process for medical devices. The report states the approval process currently does not ask the ...