COVID-19 Watch

A revised guidance for face masks and barrier face coverings changes the language of the title and text to reflect the end of the PHE. 

The UK is extending flexibilities that were introduced to ensure the supply and availability of COVID-19 and flu vaccines and has published its autumn vaccination schedule. Novavax expects to have its vaccine against the XBB strain of the virus ready by the end of September, while UK firm Infex is planning to begin clinical trials with a rival to Pfizer’s Paxlovid.

This week, a court ordered a Medtronic whistleblower to hand over records of his media contacts; Cue Health was awarded $28m to develop a multi-disease respiratory panel; and the FDA granted a zero fluoroscopy Indication to some Biosense Webster cardiac ablation devices.

The US FDA issued warning letters to three companies last month and closed out seven letters sent to companies that sold unapproved thermometers during the COVID-19 pandemic.

The cases include brothers who operated a fraudulent telemedicine firm, a lab owner who reportedly billed for unnecessary COVID-19 tests, and a former device company employee who forged FDA clearance letters.

With the latest round of discussions on a proposed global pandemic treaty starting this week, one law firm explains how the treaty’s plans for pathogen access and benefit sharing will directly affect many companies developing pandemic products.

During MD&M East in New York, Robert Austring, vice president of sales and marketing at Precision Optics, described the opportunities and challenges of marketing either reusable or single-use endoscopic devices.

Bayer's head of R&D and chief scientific officer David Evendon-Challis talked to Medtech Insight about the company's prescision health business, including a holistic and personalized approach to digital self-care.

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

The good news for the FDA is the agency has already hired 2,000 new employees this year; the bad news is they still have 2,000 more to go. FDA chief of staff Julie Tierney discussed some of the agency’s hiring successes and challenges during a recent Alliance for a Stronger FDA webinar.

The FDA updated its policies regarding 506J notifications for device manufacturers at the end of the public health emergency.

VITROS COVID-19 tests from Ortho-Clinical Diagnostics have been cleared by the US FDA, establishing regulatory pathway for future similar tests.

A coalition of health care companies wants the federal government to further strengthen the nation’s readiness to ensure the public health when the next disaster hits. Communication through a central point of command is essential, they say.

A demonstration program that provides up to eight tests per beneficiary per month is set to lift on 11 May, leaving some concerned about test access for beneficiaries. 

The US Department of Justice has filed criminal charges against 18 individuals said to be responsible for a total of $490m in COVID-19 fraud, including several device- and diagnostic-related cases.

Two regulatory attorneys spoke to Medtech Insight about the most important steps to take before the public health emergency ends, as well as what enforcement tactics they expect to see from the FDA.