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.
Medicare Patients Can Now Get Free OTC COVID-19 Tests
Medicare patients can now get over-the-counter (OTC) COVID-19 tests free of charge, CMS announced on Monday. From now through the end of the public health emergency, individuals with Medicare Part B coverage, including those in Medicare Advantage plans, can get up...
Labs in Court Weekly Roundup
Of the enforcement actions announced last week involving laboratories and the health care industry, the majority of cases involved urine drug testing. More specifically, three cases relating to urine drug testing involved an illegal kickback scheme as well as...
Explanatory AI Benefits Doctors Diagnosing Fetal Heart Disease
Researchers from the RIKEN Center for Advanced Intelligence Project (AIP) and colleagues have tested AI-enhanced diagnosis of fetal congenital heart disease in a clinical setting. Both hospital residents and fellows made more accurate diagnoses when they used a...
Radiopharmaceutical Gets FDA Approval for Treatment of Prostate Cancer
Patients with metastatic castration-resistant prostate cancer now have a new treatment option with the U.S. Food and Drug Administration’s (FDA’s) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The radiopharmaceutical medication, from Novartis...
Balwani Lawyers: Elizabeth Holmes Entirely to Blame for Theranos
"Elizabeth Holmes, not Sunny, founded Theranos and built Theranos." So spoke defense counsel Steve Cazares in his opening statement in the trial of Theranos co-founder Ramesh “Sunny” Balwani, which resumed earlier this week. Pointing the finger at the other partner...
FDA Releases Latest List of Authorized At-Home OTC COVID-19 Tests
With coverage of over-the-counter (OTC) COVID-19 tests set to expand to include those covered by Medicare, the U.S. Food and Drug Administration (FDA) recently released its most up-to-date list of authorized at-home test kits for the SARS-CoV-2 virus that causes...
FDA Getting More Muscle to Take Unproven AA Drugs Off the Market
Created in 1982 in response to the HIV/AIDS epidemic, the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) Program provides for expedited approval of novel treatments of serious health conditions that the current market isn’t adequately...
How to Protect Your Lab against Most Common Cyberattacks
According to the U.S. Department of Health & Human Services’ (HHS) Office for Civil Rights (OCR), the number of cyberattacks against the health care industry has increased in recent years. Specifically, hackers are...
Ellume Faces Class Action Lawsuit Over At-Home COVID-19 Test Kits
Back in October and November, Ellume voluntarily recalled two separate lots of its Rapid Antigen At-Home COVID-19 Test Kits due to the risk of providing false positive results. The U.S. Food & Drug Administration classed the November recall as Class I, the most...
Illumina Wins Decisive Victory in Patent Infringement Case Against BGI
After prevailing in its patent infringement lawsuit against BGI Genomics, Illumina cemented its victory by getting a permanent injunction barring the Chinese sequencing firm and its subsidiaries, including MGI Tech, from selling its sequencers and reagents in the...
