FDA allowed both qualified and unqualified entities to flood the market with COVID-19 antibody tests, and the result was “chaos,” FDA’s former chief scientist Jesse Goodman told a U.S. House subcommittee. A month after FDA tightened oversight of the tests and started withdrawing tests from the market, there is still enough concern about false results that the […]
FDA tightens oversight of serological tests for COVID-19
Manufacturers of antibody tests for the COVID-19 virus must now prove the tests’ accuracy to the FDA before they can begin marketing them. And those who do not submit their validation information to the FDA within 10 days may have those tests pulled from the market. The policy reversal follows criticism of the agency’s March […]
New AMA codes to cover e-visits and home health monitoring
The American Medical Association (AMA) has released the 2020 Current Procedural Terminology (CPT) code set, which contains identifiers and descriptors assigned to each medical, surgical and diagnostic service available to patients. Healthcare providers, insurers and researchers use CPT codes for reporting, measurement, analysis, and benchmarking of medical services and procedures nationwide. The 2020 code set […]
How one medtech company is working on solving the data dilemma
The electronic medical record was designed to better track patient care, but it has had unintended consequences. Physicians are bombarded with digital patient information all day long, reducing their patient eye-to-eye interactions and adding hours to their workday. A 2016 American Medical Association study found that physicians spent about two hours on electronic health record […]
AMA drops $15m into San Fran healthcare innovation start up
The American Medical Association is investing $15 million to be a founding partner in a new healthcare innovation company in San Francisco named Health2047. Health20147 is a newly formed for-profit company focused on developing new products, tools and resources to improve medicine and healthcare, and connect different arms of the healthcare environment together, the company […]
