The U.S. Centers for Medicare & Medicaid Services (CMS) has imposed a 60-day delay in the implementation of the Medicare Coverage of Innovative Technologies (MCIT) program, stating that the MCIT draft rule was developed under a flawed assumption about the volume of eligible breakthrough devices. CMS said the situation suggests that the public did not have an appropriate opportunity to comment on the proposed rule, a predicament that suggests the possibility that the MCIT program might not survive the Biden administration’s regulatory review.

Neuroclear Technologies Inc., a subsidiary of Biosig Technologies Inc. formed to focus on the emerging field of bioelectronics, was allowed a utility patent by the U.S. Patent Office that the company exclusively licensed from Mayo Foundation for Medical Education and Research. Neuroclear aims to use neurostimulation technology to develop novel solutions to challenging physiological and neurological disorders. The company's first target and the focus of the patent is treatment of hypertension via electroporation of renal nerves.

Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.

The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks. The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic.

The Advanced Medical Technology Association’s (Advamed) new board chairman, Michael Minogue, president and CEO of Abiomed Inc., noted that the association’s agenda for 2021 includes considerations of several headwinds. However, Advamed President and CEO Scott Whitaker said the Medicare Coverage of Innovative Technologies (MCIT) program should commence March 15 as planned, despite the overhang of the Biden administration’s regulatory review of all orders posted in the last days of the Trump administration.

The first day of the annual meeting of the American Clinical Laboratory Association (ACLA) included a brief address by two members of Congress, including Rep. Brett Guthrie (R-Ky.), who chairs the health subcommittee of the House Energy and Commerce Committee. Guthrie acknowledged that the reset of the Medicare clinical lab fee schedule was not going as intended, but declined to identify any possible fixes pending a report by the Medicare Payment Advisory Commission.

In a span of a mere two years, the state of California passed two ballot initiatives dealing with privacy that promise to have an impact on digital health, the second of which created an office specifically for privacy enforcement matters. Eric Goldman, a professor of law at the Santa Clara (California) University School of Law, said on a recent webinar that the state attorney general’s office and the new California Privacy Protection Agency (CPPA) have overlapping jurisdiction, and as a consequence, companies doing business in California may find themselves at the mercy of not one, but two enforcement entities.

Stimulating the liver with focused ultrasound decreased obesity, chronic inflammation and metabolic dysfunction in preclinical studies, reported GE Research and the Feinstein Institutes for Medical Research, the research arm of Northwell Health. In a study published in Scientific Reports, researchers demonstrated that nerve modulation with ultrasound in mice helped regulate neurons involved in food intake, glucose regulation and metabolism without negative side effects.

The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.