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First FDA-Cleared Antibiotic-Eluting BioEnvelope Now Available in U.S. for Implantable Pacemakers, Defibrillators, and Neurostimulators. SILVER SPRING, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT), a pioneer in drug-eluting biomatrix technologies, announced the U.S. commercial launch of EluPro™, the first and only FDA-cleared antibiotic-eluting biomatrix designed for use ...
The U.S. Food and Drug Administration (FDA) granted a full approval for Symvess on December 19, 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
The company submitted to the FDA in October to offer the first approved at-home cervical cancer screening. It was given a "breakthrough device designation," which means it's on an accelerated path ...
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE ...
FDA clearance: Clearance from the U.S. Food & Drug Administration, which is different from FDA approval, means that the device is equivalent to technology that’s already been approved by the ...
In May 2023, the FDA approved the iLet Bionic Pancreas system for people with Type 1 diabetes of six years and older. [5] [4] The device uses a closed-loop system to deliver both insulin and glucagon in response to sensed blood glucose levels. The 4th generation iLet prototype, presented in 2017, is around the size of an iPhone, with a ...
Dexcom was founded in 1999 by Scott Glenn, John Burd, Lauren Otsuki, Ellen Preston and Bret Megargel. [3] [4] In 2006, Dexcom received U.S. Food and Drug Administration (FDA) approval and launched the Dexcom STS Continuous Glucose Monitoring System, which is a three-day sensor that provides up to 288 glucose measurements for every 24 hours.
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
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