The FDA said it will review fewer Covid-19 diagnostics for emergency use authorization. The policy update follows an Office of Inspector General report that found the urgency to increase testing availability led to problems, including the authorization of many low-quality tests.
Technology already exists in many forms that can reduce the impact of Covid-19 in marginalized communities, but it has largely been overlooked
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company expanded a recall of its at-home Covid-19 tests due to a manufacturing error. The FDA upped the recall to a Class 1 recall, its most serious level, after noting a higher-than-acceptable false positive rate for the affected tests.
The company started with genetic testing, but expanded to Covid-19 tests and vaccines during the pandemic. It's valuation has tripled since it last raised a funding round valuing it at $1.5 billion in January.
The diagnostics company currently has an authorized at-home Covid-19 test, and plans to expand into flu tests and other diagnostics. After pricing its stock at $16 per share, it climbed to $20 on Friday.
The San Diego-based company began marketing its first product, a portable Covid-19 test, after receiving an emergency use authorization last year. Now, it’s filing the initial paperwork to go public as it scales up manufacturing.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Often overshadowed by its larger, more affluent neighbors to the west, Imperial County had few testing and vaccination resources early on. Now, flush with vaccines, groups in the county are taking targeted efforts to reach vulnerable communities.
Cue Health, a startup that won a big government contract for its at-home Covid-19 test, recently raised $235 million in funding. The startup plans to use the funds to grow and offer additional types of tests.
Ellume, a startup that won a $232 million contract to manufacture more of its over-the-counter Covid-19 tests in the U.S., has started building a manufacturing facility in Maryland. In the longer term, it plans to use the site to prepare for future outbreaks and pandemics.
After the Food and Drug Administration authorized a swathe of over-the-counter tests for Covid-19, pharmacies are preparing to stock their shelves. But at $20 to $100 a pop, will enough people use them to make a difference?
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
The Food and Drug Administration gave an emergency use authorization to two more over-the-counter Covid-19 tests that can be used without a prescription. They include Abbott’s BinaxNow test and an at-home test developed by Quidel Corp.
As the Biden Administration pushes to offer more over-the-counter Covid-19 tests, the Food and Drug Administration authorized the first molecular Covid-19 test for over-the-counter use. The test was developed by San Diego-based startup Cue Health.
A new CMS rule would require insurers to cover Covid-19 tests, even for asymptomatic patients. It builds on previous legislation requiring payers to cover the cost of both testing and vaccines for their members.
After Everlywell received an emergency use authorization last year from the FDA for its at-home collection kit, the agency gave Everlywell the green light to sell its test kits without requiring a prescription.
After completely exiting the ACA exchanges in 2018, CVS plan to re-enter them in 2022. Last year, enrollment through federal exchanges increased, and Aetna CEO Karen Lynch said the markets have stabilized.