Brace supplier settles Medicare case; AI triage for FDA device reviews; phones and pregnancy — Morning Medical Update

Brace supplier settles Medicare billing allegations for $825,000

Whistleblower to receive about $123,750 of the civil settlement.

Crown Medical Solutions LLC and its owners, Michelle and Philanzo King, agreed to pay $825,000 to resolve allegations that the durable medical equipment supplier violated the False Claims Act, the U.S. Department of Justice announced Sept. 21. The government alleged that from Nov. 1, 2017, through April 30, 2019, Crown billed Medicare for knee braces, heel stabilizers, back braces and other equipment that was not medically necessary or not properly prescribed by a physician.

The settlement amount was based on the defendants' ability to pay. It resolves a whistleblower lawsuit filed by Karen Martinelli in the U.S. District Court for the Northern District of Georgia, and she will receive about $123,750. The claims are allegations only, and there has been no determination of liability.

Study models AI triage for FDA device clearances

Model sorts 510(k) submissions by predicate recall history.

Most medical devices reach the market through the 510(k) pathway of the U.S. Food and Drug Administration (FDA), which clears them as "substantially equivalent" to a device already sold. Researchers from Indiana University, Harvard Kennedy School and Emerging Health Consulting built a machine-learning model that uses a predicate device's age and recall history to sort submissions into three groups: clear, reject or send to human reviewers. In a study in Management Science, they estimated the approach could cut FDA review workload by 40.5%, improve the recall rate by 32.9% against a current rate of 10.3% and save up to $1.7 billion a year.

The figures are modeled estimates, not results from use at the FDA. "The goal isn't to replace FDA reviewers — it's to give them better information about where their time and expertise can have the greatest impact," lead author Mohammad Zhalechian said in a news release.

Review ties heavy phone use in pregnancy to adverse outcomes

Authors say firm conclusions are premature.

A systematic review of studies published through February 2026 found that most associated prolonged or intensive cellphone use during pregnancy with adverse outcomes, particularly cardiovascular abnormalities and shorter gestation, though some found no significant association. Researchers from Columbia University, Cornell University and Johns Hopkins University published the review in the Journal of Exposure Science & Environmental Epidemiology. Many included studies could not separate radiofrequency exposure from sedentary behavior, which has its own links to reduced gestational age and restricted fetal growth.

"Drawing firm conclusions remains premature given the inconsistent findings and methodological limitations across existing studies," said co-author Ka Kahe, M.D., Sc.D., of Columbia's Mailman School of Public Health. The authors suggested speakerphone, wired headsets and keeping phones away from the abdomen to limit exposure.