Researchers Report First “Routine Clinical Use” of AI for Breast Biopsies
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LAB INDUSTRY REPORT
NATIONAL LAB REPORTER
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.
This week, two companies announced Class I recalls, the most serious kind, for COVID-19 antigen and antibody tests that have reached the US market without FDA Emergency Use Authorization (EUA) or 510(k) clearance. San Diego-based LuSys Laboratories is recalling...
When the pandemic and lockouts first began, telehealth utilization soared to unprecedented levels. But while telehealth use remains well above pre-pandemic levels, thanks in part to relaxed Medicare coverage rules, the initial wave steadily ebbed starting in May...
Certain cancer patients now have access to a new treatment option and companion diagnostic. On March 11, the U.S. Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for treating adults with deleterious or suspected...
Recently unveiled program aims to ensure easy access to COVID-19 treatments for all eligible Americans.
Just as it seemed like physician practice patterns were getting back to normal, the late-year Omicron surge skewed the Merit-based Incentive Payment System (MIPS) quality data for 2021. With that in mind, the Centers for Medicare & Medicaid Services (CMS) has...
For scientists and clinicians alike, one of the Holy Grails for successfully treating and curing Lyme disease is developing tests that identify the disease sooner, show when people are cured of infection, and can diagnose reinfection. Now, researchers at Tufts...
For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency...
Last week, Chinese genomics company Singleron Biotechnologies, which develops single-cell multi-omics platform technologies and helps translate them to the clinic, announced it had acquired Proteona Pte. Ltd. Based in Singapore, Proteona is also focused on the...
Home-based, self-administered tests for influenza are comparable in accuracy to rapid diagnostic tests in clinical settings, according to a recently published, peer-reviewed study. “Home tests are a valuable tool to support the management of influenza and other...
Research has found an early screening tool for autism developed by La Trobe University, Australia, researchers—and already used across eleven countries—is the world's most accurate. Published in JAMA Open, the five-year study of over 13,500 Victorian children found...