Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Bonesupport, Cosm Medical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exact Sciences, Guardant Health, Naveris, Neurometrix, Prelude.
In what represents their first patenting, a researcher from the University of California is seeking protection for non-invasive methods of brain monitoring that use electroencephalography (EEG) to detect new or worsening brain injury in pediatric patients.
Medicare coverage of medical software in the U.S. is generally not the subject of flattering remarks from industry, but the novelty of the subcategory of artificial intelligence (AI) would seem to suggest that the Medicare problem for AI is even more severe. That suspicion was borne out by consultant Bruce Quinn who said at a public meeting here in Washington that some areas of software coverage and reimbursement, including AI software, “are just a train wreck,” a problem he said is especially acute in fee-for-service care.
Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took us four years and we spent more than €700,000 to get approval under the MDR for the same product that we already had CE mark for under the Medical Device Directive for the last 10 years or so,” Oren Malchin, CEO of Pulsecath, told BioWorld.
Shanghai Fosun Pharmaceutical Co. Ltd has formed a partnership with seven other investors to form an investment fund partnership that plans to invest ¥5 billion (US$695M) in local biotech and med-tech companies in Shenzhen, China. The target fund will concentrate on local biotechs, including cell and gene therapy companies, as well as other industries, with 70% to be invested in the biomedical industry.
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