Many of the developers of in vitro diagnostic tests will seek to convert their emergency use authorizations (EUAs) to conventional premarket filings, and Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said a draft guidance for this conversion is in process. However, Stenzel said he could not predict when that draft might emerge, given that the agency is still scrambling to keep up with both EUA and conventional applications.

Lucira Health Inc. has secured U.S. FDA emergency use authorization for the first prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. The single-use, COVID-19 All-in-One Test Kit employs a simple ‘swab, stir and detect’ design that yields results within 30 minutes – enabling individuals who expect they have the virus to get results while isolating at home.

The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue.

The U.S. FDA granted 510(k) clearance to Lantheus Holdings Inc.'s artificial intelligence (AI)-enhanced automated bone scan index (aBSI) product for prostate cancer on GE Healthcare's Xeleris platform. ABSI improves quantification and management of disease progression in advanced prostate cancer patients.

TORONTO – A Canadian plant-based, cellulose scaffold implant for regenerating healthy spinal cord tissue has received U.S. FDA breakthrough device designation. The designation will enhance the process by which Ottawa-based Spiderwort Inc. interacts with the FDA during regulatory review of the Cellubridge implant, said Spiderwort CSO and cofounder Andrew Pelling, speeding its way to clinical trials.

Regulation of the digital health space is in some respects fundamentally different from traditional hardware medical devices, a fact that was highlighted during a Nov. 12 webinar hosted by the U.S. FDA. Nonetheless, several participants in the webinar made the point that the twin problems of coverage and reimbursement are critical issues for digital health as well, a problem that some see as requiring more collaboration between the FDA and the Centers for Medicare & Medicaid Services (CMS).

Some PMA filings manage to scrape by at U.S. FDA advisory hearings, but the application for the Visability device by Refocus Group Inc. was not one of those. The panel voted 15-1 that the benefits of the device for presbyopia did not outweigh the risks, leaving the sponsor with a fundamental question about the viability of a technology that has been under development for more than 20 years.