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 Medtronic Corevalve platform for lower risk of severe valve deterioration compared to surgical replacement.
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. Read More
Neuraxis Inc. has initiated a clinical 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.
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 Centers for Medicare and Medicaid Services. The clearance of Claritypro to diagnose ESE 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. Read More
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boditech, Clearday, FJ Orthopedie, Heart Test Laboratories, Heartsciences, Viveon. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Livanova. Read More
