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.
Keeping you up to date on recent developments in diagnostics, including: Border detection algorithm for melanoma; Predicting future suicide risk; Multiracial study gives new diabetes insights; Patient genetic variants linked to wound microbiomes.
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.
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.
Mainstay Medical Holdings plc has won U.S. FDA approval for its Reactiv8 implantable neurostimulation device. The company is eyeing a commercial launch of the system in early 2021. The FDA approved Reactiv8 as an aid in managing intractable chronic low back pain associated with multifidus muscle dysfunction in adults who have failed therapy and are not candidates for spine surgery.
Smart assisted surgery company Naviswiss AG, of Brugg, Switzerland, has gained U.S. FDA clearance for its miniature navigation technology for hip replacement surgery. The hand-held system, with an open platform that supports all implant vendors, is being offered on a fee per-use basis.
The potential for neurological complications, including seizures and stroke, is a growing concern with COVID-19 patients. To ensure rapid diagnosis and treatment, Ceribell Inc., a Mountain View, Calif.-based startup, is deploying its cloud-linked, portable electroencephalogram (EEG) device to enable EEG assessments in minutes in emergency rooms and intensive care units.
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of pulmonary hypertension; A web-based COVID-19 assessment tool; Discovering pharmacological enzyme activators.
The COVID-19 pandemic has fueled an unprecedented uptick in telehealth use, from medical and behavioral health services to remote patient monitoring, as federal and state regulators have relaxed certain policy restrictions to increase access to care. Sen. Lamar Alexander (R-Tenn.) recommended in a Senate hearing that certain temporary policy changes, such as elimination of the “originating site” rule and expansion of Medicare- and Medicaid-covered telehealth services, should be lasting to ensure patients retain health care access when the crisis is over.
