Senators recently introduced a bill that would require coverage for individuals with a family history of hereditary cancer.
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Guidelines on use of genetic testing for inherited cardiovascular diseases have been revised in accordance with 2022 testing technology.
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
A recent study suggests that the US should standardize breast density reporting and require that all women receive notification.
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
A recent study shows these tests may make it easier and more cost-effective to identify patients for studies of new PET treatments.
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.