Corvia Medical Inc. has closed $54 million in equity financing to support a confirmatory trial for its Interatrial Shunt Device, designed to reverse diastolic heart failure (HF), otherwise known as “preserved ejection fraction” (HFpEF), and which affects millions of Americans. This follows results of the largest randomized controlled trial of a device-based therapy published in February 2022, with a 45% reduction in HF events and a 55% greater improvement in patient quality of life.
Health Canada approved a device which Wayne, Pa.-based Teleflex Inc. described as the first commercially available biomechanical vascular device designed to close large holes in the femoral artery during endovascular catheterization procedures.
Camera pills were never quite like this. Developed by Vibrant Gastro Inc. for people suffering from chronic idiopathic constipation (CIC) the Vibrant system capsule is designed to travel deep into the gut and vibrate, augmenting the natural mechanisms of the body that govern bowel function.
A tissue engineered polymer wrap designed to reduce vein graft failure rates in patients on hemodialysis for chronic kidney disease (CKD) has won FDA breakthrough device designation. Developed by Houston-based Venostent Inc., the Selfwrap bioabsorbable perivascular wrap is macroporous material that wraps around blood vessels and acts as a scaffold to ensure veins and arteries work together seamlessly to filter out toxins in the patient’s blood.
The full U.S. commercial launch of the UltraguideTFR is intended to crack a market of nearly nine million Americas suffering from a painful condition known as trigger finger, which is caused by the progressive restriction of tendon motion and the ability to bend and straighten the fingers.
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance.
Bridge to Life Ltd. has won FDA breakthrough device designation for its Lifecradle Heart Preservation Transport System enabling clinicians to affordably implement hypothermic oxygenated perfusion of heart grafts during organ transport. Lifecradle employs a “plug-and-play” design to differentiate it from historic static cold storage but also from “normothermic” preservation which provides oxygen delivery at near physiologic temperatures.
Canada’s federally-funded Digital Technology Supercluster is joining with industry to invest CA$17.8 million (US$13.9 million) in an artificial intelligence (AI)-powered technologies program to advance personalized treatment for patients with cancer.
Yes, getting FDA 510(k) clearance for your medical device is something to cheer about. But consider Arterys Inc. It just reported its eighth FDA clearance, this time for a next generation, deep learning cardiac analytics platform. The Cardio AI’s purpose, Arterys CEO John Axerio-Cilies told BioWorld, is to leverage artificial intelligence (AI) and deep learning for analysis of cardiac MRI images that is faster, more accurate and repeatable than ultrasound and other imaging modalities.
Perkinelmer Inc. said the Vega is a first-of-its-kind preclinical ultrasound system that will accelerate preclinical research and drug development studies of cancer, cardiovascular, liver, kidney and other diseases. The imaging platform combines hands-free automation with high-throughput capability, which the company said is a major advance over manual ultrasound scanning across the bodies of individual lab mice.
