A Closer Lab-Patient Connection
Patient access to data from the clinical lab is increasing. What does this mean for those generating it?
Diagnostic Testing and Emerging Technologies
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
New and Improved: The Latest Research in Disease Screening
New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes
A Lasting Impact: COVID-19 and Cancer Screening
Several years after the onset of the COVID-19 pandemic, labs are still dealing with the effects of missed and delayed screenings
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.
Omicron Drives New Surge in National Telehealth Utilization
...
Already a member? Log in here
One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
...
Already a member? Log in here
Breast Cancer Screening Overdiagnosis Rate Is Only 15 Percent: Study
...
Already a member? Log in here
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.
Plugging Current Gaps in Cancer Screening Will Save Lives
...
Already a member? Log in here
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.
EC to Phase in New In Vitro Diagnostic Regulation, Starting May 26
...
Already a member? Log in here
