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COVID-19 Watch

Set Alert for Medtech Insight - Coronavirus COVID-19

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. 

FDA Regulation

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.

International Europe

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.

Legal Issues Enforcement

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.

FDA Warning Letters

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.

Policy Legal Issues

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.

Europe International

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.

Business Strategies Commercial

‘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.

Business Strategies Digital Health

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.

Coronavirus COVID-19 OTC Devices

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 Policy

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.

Coronavirus COVID-19 FDA

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.

Regulation Approvals

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.

Policy Supply Chain

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. 

Coronavirus COVID-19 Policy

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.

Policy Coronavirus COVID-19

‘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.

Policy Coronavirus COVID-19
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