If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.

Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA).

Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder.