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FDA Face Mask Guidance Updated To Reflect End Of PHE
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.

New WHO Recommendations On Access To COVID-19 Products Highlight Spread Of New EG.5 Variant
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.

News We’re Watching: Medtronic Kickbacks Case, BARDA Contract For Cue, Imeka Neuroimaging Software Cleared
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.

Warning Letters And Close-Outs – July 2023
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.

DOJ Announces Three Medtech-Related Enforcement Actions
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.

EU Ups Funding For Pandemic R&D, Parliament Backs ‘Strategic Autonomy’ In Medical Product Development
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.

To Reuse, Or Not To Reuse: The Pros And Cons Of Reprocessed Endoscopic Devices
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.

‘Faster, Better, More Efficient’ – Why Bayer Is Investing In ‘Precision Health’
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.

Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
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.

Despite New Hires, Personnel Challenges Remain For FDA
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.

FDA Encourages Voluntary Device Shortage Reporting After PHE End
The FDA updated its policies regarding 506J notifications for device manufacturers at the end of the public health emergency.

Quidel Subsidiary Lands First De Novo Clearance For COVID-19 Serology Tests
VITROS COVID-19 tests from Ortho-Clinical Diagnostics have been cleared by the US FDA, establishing regulatory pathway for future similar tests.

Healthcare Leaders Warn Nation Not Fully Prepared For The Next Disaster
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.

CMS Announces End To Free OTC COVID-19 Tests For Medicare Patients
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.

Lab Owner, Test Kit Vendors Charged In COVID-19 Fraud Crackdown
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.

‘Get Ahead Of The Curve’ By Preparing for EUA End, Attorneys Say
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.
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