Page 4 - Device Designation News Today

ZKR Orthopedics earned the FDAs Breakthrough Device Designation for its LIFT implant technology for knee care, according to an Oct. 9 news release. 

(RTTNews) - SeaStar Medical Holding Corp. (ICU) announced receipt of FDA Breakthrough Device Designation for its patented cell-directed Selective ...

Onward Medical passed another developmental milestone on Wednesday with the first successful successful use of its electrode array to restore function to a patient’s upper limbs.

/PRNewswire/ -- Cardiosense, a digital health company developing a non-invasive monitoring platform for the early detection of heart disease, recently started...

Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) clearance from the U.S. Food and Drug Adm…

First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program 

/PRNewswire/ -- Limaca Medical ("Limaca") announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U....

CytoSorbents Reports Fourth Quarter and Full Year 2022 Results Pivotal U.S. and Canada STAR-T Trial enrollment passes halfway mark. Positive sales ...

The developer of the Elevate heart pump system, Magenta Medical, recently announced the completion of its FDA-approved Early Feasibility Study for the high-risk percutaneous coronary intervention (HR-PCI) indication.

Received FDA Breakthrough Device Designation for Candida auris test, achieved record quarterly sepsis test panel orders and received second largest sepsis driven T2Dx® Instrument order LEXINGTON,...