Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam.
The Belgian academic Stefan De Wachter is seeking patent protection for methods of ensuring pelvic health and treating a disease or disorder characterized by a dysfunctional autonomic nervous system using neuromodulation and applying a burst stimulation pattern of electric pulses of high frequencies from electrodes located in the proximity of the sacral plexus and/or pelvic plexus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerin, Appliedvr, Kernel, Cleerly, Medrhythms, MIVI Neuroscience.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuryn, Biotronik, Evaluate Diagnostics, Exactech, GE Healthcare, Hitachi, IMDS, Inspira Technologies, Lucid Diagnostics, Medquest, Obviohealth, Oracle, Potrero, Qiagen, Spectrum Science, Statera, Sysmex, Volta Labs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fresenius Medical Care, Sibel Health.
COVID-19 severity remains open to several questions. Researchers at the University of California Los Angeles (UCLA) have revealed how SARS-CoV-2 causes acute inflammation instead of the symptoms of a common cold. This effect could be initiated by the peptide fragments of the coronavirus released when the host eliminates the virus, which can form pro-inflammatory complexes that trigger an amplified immune response.
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
There is no doubt that the fundraising environment in Europe remains challenging for med-tech companies. Currently it seems like “the winner takes it all,” with companies that have de-risked their portfolio able to find investors to provide funds, while for those at the earlier stages, finding capital continues to be ‘tricky,’ Raphaël Wisniewski, partner at European private equity firm Andera Partners, told BioWorld in an interview.