The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Stimulus passes, no Medicare sequestration relief; OIG cites improper claims for polysomnography; Four senators seek feedback on Section 101 hangup.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akesis, Breath Direct, Clew, Datar Cancer Genetics.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rep. Payne resurrects colorectal cancer screening bill; Former Practice Fusion employee enters guilty plea; NICE says Alpha-Stim not ready for anxiety disorder.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Able Medical, Eitan Medical, Empatica, Inivata, Mahana Therapeutics, Roche.
Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.
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.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.