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December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
New Urine Test Can Detect Synthetic Cannabinoids in Marijuana
Recent study shows the new test can identify a widespread and dangerous class of synthetic cannabinoids called BZO-CHMOXIZID.
SCOTUS Won’t Weigh in on How Whistleblowers Make Valid FCA Claims
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
White House Unveils New “Bill of Rights” for Responsible Use of AI
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
Weekly Enforcement Report: Doctors in Hot Water for Billing-Related Issues
While again light on lab-related cases, this week’s healthcare-related enforcement actions featured improper billing, kickbacks, and telemedicine.
AACC Revises Reproductive POC Lab Test Guidelines
POC tests offer speed and simplicity, but are less reliable than tests performed in labs.
New Breast Density Reporting Final Rule Set to Be Released
FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.
Changing Times and Eroding Margins: RCM Solutions
Learn how to comprehend the difficulties of revenue cycle management and practical technology-based solutions in this free webinar.
FDA to Consider Health Disparities in Granting Breakthrough Device Designation
Medical device makers will have to show that their products will be accessible to disadvantaged populations.