AI in Health Care: Balancing Benefits and Barriers
AI can help alleviate the burden on clinical labs—but only with sufficient investment, enthusiasm, and understanding
Diagnostic Testing and Emerging Technologies
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Computing the Future of the Lab
Computational biology expert Keaun Amani shares his advice and insights on AI and machine learning tools for the clinical lab
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With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.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.
Omicron Drives New Surge in National Telehealth Utilization
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One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
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Breast Cancer Screening Overdiagnosis Rate Is Only 15 Percent: Study
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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
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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.
