With the push for value-based care, health care players – from manufacturers, to providers, to payers – are looking for ways to improve patient quality while reducing the costs of care. Advanced technologies, including digital health and artificial intelligence (AI)-based tools, are a major part of the equation, but companies face several challenges and barriers to adoption. To that end, management consultancy has launched a new Health Tech website featuring a Health Tech Industry Accounting Guide and other helpful advice for health-tech companies.
Orthopedic implant startup Engage Surgical has received 510(k) clearance from the FDA for its Engage Partial Knee system, the only cementless partial knee implant available in the U.S. The company is introducing the product via a limited release to select surgical centers.
The U.S. FDA has greenlighted Ancora Heart Inc.’s IDE request to conduct the Corcinch-HF pivotal clinical trial. The study is intended to demonstrate the safety and effectiveness of the Accucinch ventricular restoration system in patients with heart failure and reduced ejection fraction (HFrEF).
Envoy Medical Corp. got some early support for its Acclaim fully implantable cochlear implant, with a breakthrough device designation from the U.S. FDA. If approved, it would be the first cochlear implant to address hearing loss without the use of any external components.
Elixir Medical Corp., reported positive 12-month results for its Dynamx Coronary Bioadaptor System, with no target vessel revascularization (TVR) or stent thrombosis and adaptive remodeling of the artery to sustain healthy blood flow. The findings, from a multisite European trial, were presented during a late-breaking trials session at the PCR e-Course virtual meeting in Paris.
Medtronic plc has won the U.S. FDA’s nod for the first deep brain stimulation (DBS) system that integrates Brainsense, the company’s technology to sense and record brain signals for more personalized treatment. The next-generation Percept PC DBS with Brainsense is approved to treat symptoms associated with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder.
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French startup Affluent Medical SA has launched a European pilot study in humans of its native-like transcatheter mitral valve technology. The Epygon valve is designed to restore the normal blood flow vortex in the left side of the heart and treat left ventricle disease, particularly in so-called “functional” patients. Coinciding with the launch of the pilot, the company announced €10.3 million (US$11.6 million) in new financing and the addition of three new members on its board of directors.
Sommetrics Inc. said Tuesday that it has requested emergency use authorization from the U.S. FDA to market its Aersleep II device for sleep apnea patients at risk of COVID-19. The aim is to reduce the transmission of SARS-CoV-2, the virus that causes COVID-19, by treating infected patients with sleep apnea with Aersleep instead of continuous positive airway pressure (CPAP) therapy.