Will Blowing in a Device Be Useful in Screening for COVID-19? FDA Grants Its First EUA for a Breathalyzer SARS-CoV-2 Screening Test

InspectIR COVID-19 Breathalyzer identifies a chemical signature associated with SARS-CoV-2 in about three minutes with 91.2% sensitivity and 99.3% specificity One company is hoping that it can make breathalyzers a viable, easier way to screen for SARS-CoV-2. It will soon have the opportunity to learn if consumers will accept this form of screening for COVID-19, as its device recently obtained an Emergency Use Authorization from the FDA. On April 14, 2022, InspectIR Systems, LLC, of Frisco,...

Coronavirus Fraud Takes Many Forms as Federal and Local Officials Continue to Pursue Widespread Cases of Clinical Laboratory Testing Scams

Since the pandemic began, federal investigators are specifically looking for patterns of fraud in Medicare claims data for COVID-19 clinical laboratory testing Last month, the federal Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced it had been investigating trends in Medicare claims data that could indicate patterns of fraud in the billing for COVID-19 clinical laboratory tests, Modern Healthcare reported. Stretching back to at least March, fraudulent...

Canadian Scientists and Medical Researchers Urge Health Canada to Regulate Laboratory-developed Tests

Lack of regulations and quality management jeopardizes the quality and safety of LDTs, claim experts in clinical laboratory medicine in a commentary to Canadian policymakers Health Canada is the latest government healthcare organization under pressure to enact legislation that regulates laboratory-developed tests (LDTs). In a public commentary, several members of the Institute of Health Policy, Management and Evaluation (IHPME) at the University of Toronto in Ontario, urged Canadian lawmakers...

Pathologists and Researchers Predict Development Trajectory for Biomarker-based Molecular Diagnostics in Support of Translational Medicine

Emerging field of translational medicine expected to contribute to more informative studies that provide superior data for making medical decisions These are boom times for translational medicine. That’s the term used to describe how the health of individuals and the community can be improved through applying new knowledge into diagnostic tools (including medical laboratory tests), medicines, procedures, policies, and education. Rapid developments in the field of translational medicine include...

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers. You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally...
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