Medtronic plc presented 10-year results from its ongoing trial comparing transcatheter aortic valve implantation with surgical aortic valve replacement. The results support use of the Corevalve platform for lower risk of severe valve deterioration compared to surgical replacement.
UK allocates £13M for research into AI projects in health care
The U.K. government’s recent allocation of £13 million (US$16.5 million) to fund research that will deliver cutting-edge artificial intelligence (AI) projects is a sign of its ongoing commitment to use the latest innovative technologies to modernize the health care sector. However, a group of MPs have released a report which warned that although AI offers significant opportunities there remains governance challenges that must be addressed.
Neuraxis looks beyond gut to apply IB-Stim in post-concussion syndrome
Neuraxis Inc. has initiated a study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that occur after mild traumatic brain injury such as headaches, dizziness and problems with concentration and memory. Currently enrolling up to 100 patients, the randomized, double-blind, placebo-controlled trial is being conducted at Children’s Hospital of Orange County, Calif. Its primary endpoint is improvement in validated measures, including the immediate post-concussion assessment, post-concussion symptom scale and balance error scoring symptom system, compared with placebo.
Ceribell scores string of wins following clearance of bedside Claritypro
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the U.S. Centers for Medicare and Medicaid Services. The clearance of Claritypro to treat prolonged ESE seizures follows receipt of an FDA breakthrough device designation in two different categories in the past year, setting the stage, Ceribell CEO Jane Chao told BioWorld, for expanded access to critical seizure diagnosis technology.
Medalliance unveils drug-eluting balloon for dialysis complications
Medalliance SA reported completion of patient enrollment in the SAVE clinical trial with its Selution SLR 018 drug-eluting balloon. Eighty-four subjects have been recruited for this prospective multi-center, single-blinded, randomized controlled trial. These patients received either standard high-pressure balloon angioplasty followed by local application of Selution SLR, or else high-pressure balloon angioplasty with no further lesion treatment.