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.
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Lab Compliance Will Change When Public Health Emergency Ends
Your current COVID-19 testing arrangements may no longer be compliant on May 11.
Weekly Enforcement Report: Telemedicine Scheme Trend Continues
Most of last week’s healthcare-related actions involved telemedicine in some way, with the lone lab-related case centering on genetic testing.
FDA Orders LuSys and Celltrion to Recall Unauthorized COVID-19 Rapid Tests
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...
After Steady Decline, Telehealth Use Surges during Omicron
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...
FDA Grants Approval to Breast Cancer Treatment and Companion Diagnostic
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...
US Government Launches Nationwide Test-to-Treat Initiative
Recently unveiled program aims to ensure easy access to COVID-19 treatments for all eligible Americans.
Physicians Get a Break on 2021 MIPS Payment Adjustments
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...
Potential New Test Could Diagnose Lyme Disease Sooner
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...
FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees
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...
Singleron Extends Reach outside of China with Acquisition of Proteona
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 Flu Tests as Accurate as Rapid In-Clinic Options
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...
Study Finds Screening Tool for Autism Is World’s Most Accurate
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...
