NanoDrop is the First Over-the-Counter Blood-Lancing Device Labeled for the Upper Arm to be Cleared in the United States, Changing the Landscape of the At-Home Consumer Testing Market and Decentralized Clinical Trials
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery
Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction (Low EF) AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam
Ross Bjella, Kelyniam’s CEO, said, “This approval will further boost Kelyniam’s sales momentum which started in Q4 last year
The FDA’s Investigational Device Exemption (IDE) clears the way for a pivotal study of Fractyl’s Revita system designed to maintain weight loss after patients have stopped taking GLP-1 drugs
The company is pitching the test as a way to improve the safety and availability of blood.
Endorail is a magnetic balloon solution that optimises colonoscopy procedural outcomes.
Near-Infrared fluorescence now available on Modus X robotic exoscope, complementing system’s existing advanced fluorescence capabilities
The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
“We are thrilled to receive 510(k) clearance for SyMRI 3D,” says Ulrik Harrysson, CEO at SyntheticMR AB”