The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helix, Nanotronics Health.
Neura Inc., which focuses on AI-powered behavioral intelligence that provides real-world insights for health organizations, governments and consumer brands, has revealed the adoption of its Viruscore COVID-19 predictive testing solution.
The COVID-19 pandemic has sparked some innovation in testing, but not all that innovation has made it to market. Michael Mina, an assistant professor of epidemiology at the Chan School of Public Health at Harvard University, said on an Aug. 7 conference call that the U.S. FDA’s “archaic view” of testing is impeding the use of paper strip tests he said would turn the tide in the effort to contain the pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Guardant Health, Scientia Vascular.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arc Medical Design, Anpac Bio-Medical Science, BBS-Bioactive Bone Substitutes, Bruker, Establishment Labs Holdings, Highmark, Mdxhealth, Norgine Orion Trading, Olympus, Sbl Technologies, Senseonics, Sparta, Todos Medical.
Improving metabolic disorders without major changes in diet and exercise is typically seen as impossible, unless bariatric surgery is involved. But that’s precisely what Fractyl Laboratories Inc. aims to do. It plans to start a pivotal trial of its duodenal mucosal resurfacing system, Revita DMR, before year end.