A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.

Roughly four years after Intuitive Surgical Inc. petitioned for an inter partes review for a patent owned by Ethicon Endo-Surgery Inc., the Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board (PTAB) finding that the first 14 claims in Ethicon’s 9,585,658 patent are invalid. While the fate of two other claims are still up in the air pending remand to the PTAB, the net effect of the hearing was significantly damaging to an Ethicon patent for surgical staplers that has been in place for only four years.

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.