The U.S. Centers for Medicare & Medicaid Services proposed to use AI to cut down on abuse of the Medicare program, but several members of Congress have concerns about the notion, given that private payers have used AI to illegitimately deny services to their beneficiaries.
The reach of the med-tech patent wars now includes devices for electroencephalography thanks to a complaint recently filed by Sunnyvale, Calif.-based Ceribell Inc. with the U.S. International Trade Commission. The company alleged infringement of six of its patents by two units under the Natus umbrella of companies, but this conflict is also under review in Delaware district court, promising a drawn-out conflict that may not resolve for years.
The issues facing the EU’s Medical Device Regulation and the In Vitro Diagnostic Regulation are the stuff of legend, but the EU’s notified body group, TEAM NB, has proposed a mechanism to deal with some of the administrative problems.
The FDA’s warning letter to Whoop Inc. resurrects questions about the agency’s observance of the 21st Century Cures Act in that the warning letter stakes out the position that any reading of blood pressure is “inherently associated” with hypertension.
Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).
Kingsley Chin, the CEO of Spinefrontier Inc., has been sentenced to a year of supervised release for his role in the payment of less than $5,000 in consulting fees to a surgeon who provided no consulting services.
The U.S. FDA posted an Aug. 6 early alert regarding the use of the Watchman left atrial appendage device by Boston Scientific Corp., citing instances in which the device’s delivery system is associated with events of embolism.
The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.
The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs.
The U.S. FDA has staked out a position on the use of per- and polyfluoroalkyl substances in medical devices, declaring that the evidence offers no reason to restrict their continued use in med-tech products.
