Congress Moves to Expand Medicare Coverage of Genetic Cancer Screening
Senators recently introduced a bill that would require coverage for individuals with a family history of hereditary cancer.
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Global DTC Genetic Testing Market to Top $1.9B by 2026
Even when accounting for the impact of COVID-19, recent report suggests the future of direct-to-consumer genetic testing remains bright.
Cardiovascular Genetic Testing Guidelines Get a Technology Makeover
Guidelines on use of genetic testing for inherited cardiovascular diseases have been revised in accordance with 2022 testing technology.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
Breast Tissue Density Reporting Should Cover All Women
A recent study suggests that the US should standardize breast density reporting and require that all women receive notification.
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
How CSF Tests May Help Recruitment for Alzheimer’s Drug Clinical Trials
A recent study shows these tests may make it easier and more cost-effective to identify patients for studies of new PET treatments.
2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
