Welldoc Submits 510(k) to FDA for CGM-Informed Glucose Prediction Feature

Welldoc®, a leader in AI-powered cardiometabolic health solutions, today announced the submission of a 510(k) premarket ...
Nasdaq

Celularity to submit 510(k) notification for Tendon Wrap in early 2025

Celularity (CELU) issued a Corporate Update to Shareholders from Robert Hariri, Founder, Chairman, and CEO, which read in part, “Let me start by reiterating what we said in our announcement last week, ...
Zacks Investment Research on MSN

KRMD submits 510(k) to use FreedomEDGE system with oncology biologic

KORU Medical Systems, Inc.KRMD recently announced that it has submitted a 510(k) premarket notification for FDA clearance to ...

KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic

KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on ...
Business Wire

Fresenius Kabi Submits 510(k) Notification for the Aurora Xi Plasmapheresis System Software Version 2.0 with New Nomogram

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, an operating company of Fresenius, announced today it has submitted a 510(k) notification to the U.S. Food and Drug Administration seeking clearance ...
TipRanks on MSN

Koru Medical submits FreedomEDGE 510(k) premarket notification to the FDA

Koru Medical (KRMD) announced the submission of a 510(k) premarket notification to the FDA seeking clearance for the use of Koru Medical’s ...
MobiHealthNews

New 510(k) notification offers more clues on AliveCor's next moves

Another recent update to the FDA’s 510(k) premarket notification database suggests that AliveCor is inching closer and closer to its next volley of smartphone-connected ECG products. According to the ...
Seeking Alpha

Intelligent Bio Solutions Provides Update on FDA 510(k) Clearance Process for Intelligent Fingerprinting Drug Screening System

NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing ...