Medtronic has received US Food and Drug Administration (FDA) 510 (k) clearance for its MiniMed Go Smart MDI system, a ...

The decision follows a comprehensive review that found no link between GLP-1 RA use and suicidal ideation or behavior. ・The ...

FDA-cleared AI-CVD® extracts preventive insights from routine CT—identifying hidden cardiovascular, metabolic, and ...

The FDA has granted 510(k) clearance to Medtronic for its MiniMed “Go Smart” multiple daily injection system — the first ...

The FDA has cleared the first app that integrates glucose data with multiple daily injection (MDI) insulin dosing for people with diabetes.

ST. PAUL, Minn., /PRNewswire/ -- iotaMotion, Inc., creator of iotaSOFT®, the first and only FDA cleared robotic-assisted ...

AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from ...

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

The FDA has cleared a mobile application that will connect with a next-generation multiple daily injection automated insulin ...

The wearable device delivers electrical impulses through a headset that can be administered by the patient at home under physician oversight.

EDOF technology, previously used in intraocular lenses, is now available in contact lenses, offering significant improvements ...

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...