COVID-19 Watch

At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

Members of the US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee met on 6 February to discuss what medical devices are critical to public health during a national emergency and help the FDA create a list of those devices.

During a recent webinar hosted by the Alliance for a Stronger FDA, commissioner Robert Califf discussed the agency’s 2024 budget, its ongoing reorganization, AI, LDTs, and the continuing problem of misinformation.

A new annual report argues that last year was both transformative and historic for the US FDA’s Center for Devices and Radiological Health. The center authorized the highest number of novel medical devices in history while turning the corner on the pandemic.

Manufacturers including BioFire, Cepheid and Roche have already secured multiple 510(k) or de novo clearances from the US FDA. However, more than 400 COVID-19 diagnostics remain on the market under EUAs.

Keith Berman claimed to investors that his company, Decision Diagnostics, was on the verge of releasing a groundbreaking COVID-19 test. The problem? It wasn’t true. 

The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.

This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.

The test is among the first of a wave of products initially authorized for emergency use by the US FDA that are now pursuing traditional approval pathways to stay on the market. 

Amazon announced it will offer Prime members a One Medical subscription for $9 a month, or $99 a year in a move to “make it easier for people to get the health care they need.”

Legislation introduced in the US Senate by Wisconsin’s Tammy Baldwin would beef up the nation’s flu preparedness by investing in new technology for vaccine and diagnostic development as well as treatments.

This week, 25 state attorneys general pressed FDA Commissioner Robert Califf to improve pulse oximeter safety warnings; MDIC extended the deadline on an industry cybersecurity benchmark study; and more guilty pleas and settlements were entered in Medicare fraud cases.

Lack of laboratory quality management procedures and resource shortages were behind the CDC’s troubles in developing a COVID-19 diagnostic in 2020, an HHS OIG audit found.

New York business partners continued false advertising for “The 1 Virus Buster Card,” to be worn around the neck or clipped onto clothing, on their website and social media platforms after receiving a warning from the US FTC in July 2020.

A new report from the US International Trade Commission found that patents had a mixed effect on access to diagnostics and therapeutics during the COVID-19 pandemic. Trade group AdvaMed says the findings demonstrate that patent waiver programs aren’t needed for COVID-19 diagnostics.