Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App

Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...
Medscape

FDA Clears First In-Ear EEG Device

The Naox Link system uses soft, biocompatible in-ear electrodes integrated into wired earbuds to acquire, record, and ...

REMSleep Outlines Q1 2026 Commercial Strategy: Expanded FDA Application, B2B Launch Prep, and Institutional Market Entry

Company Transitions from Infrastructure Buildout to Active Market Execution as Expanded 510(k) Review Enters Final ...
MedPage Today on MSN

First in-ear EEG device gets FDA clearance

The Naox Link in-ear EEG platform is the first of its kind to be cleared for prescription use at home or in healthcare ...

FDA Clears Next-Generation RefleXion Platform That Improves Tumor Detection

RefleXion Medical, an external-beam theranostic oncology company, today announced the U.S. Food and Drug Administration has cleared its next generation, autonomously-guided oncology platform, the ...

Kelonia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for KLN-1010, an in vivo BCMA CAR-T Therapy for Relapsed and Refractory Multiple Myeloma

Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational ...
MassDevice

BrainSpace wins FDA clearance for automated brain fluid management device

BrainSpace announced that the FDA granted 510(k) clearance for its Intellidrop automated brain fluid management system.
MedTech Dive

J&J submits FDA de novo request for Ottava robot in general surgery

Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft ...
Los Angeles Business Journal

FDA Grants Pearl Third Clearance

Pearl, a dental technology startup based in West Hollywood, announced in mid-December the U.S. Food and Drug Administration ...
Yahoo

FDA clears Moderna’s new COVID vaccine, but with limits

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — The Food and Drug Administration has granted ...
Becker's Hospital Review

FDA clears Walgreens in drug listing violations case

The FDA said Walgreens has addressed violations related to drug listing deficiencies for one of its products, according to a Dec. 19 close-out letter. The agency previously cited Walgreens in ...