The Medical Device Coordination Group (MDCG) posted a guidance document tackling the interaction between the Artificial Intelligence Act and the twin EU regulations for devices and diagnostics, but the lack of standards for AI development promises to impede efforts to bring these AI algorithms to the European market.
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
The U.S. Office of Inspector General issued a report stating the Medicare program often pays for physician services that are not performed post-surgery, but the Centers for Medicare & Medicaid Services responded it is in no position to immediately begin tracking all excess payments under these global codes.
It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.
In subpoenaing a former Pfizer Inc. official to appear before the U.S. House Judiciary Committee July 22, Judiciary Chair Jim Jordan, R-Ohio, signaled legislative steps Congress may take in response to allegations that Pfizer slow-walked its COVID-19 vaccine development in 2020 so the trial results wouldn’t have to be disclosed until after the presidential election.
The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous glucose monitors and insulin pumps to competitive bidding, but the agency is also considering a more rapid pace of replacement of these technologies.
Anaconda Biomed SL recently received CE mark for the Ana5 funnel catheter, designed to improve mechanical thrombectomy in the treatment of acute ischemic stroke. The company hopes that the device, which has a vessel-matching diameter funnel to maximize the capture of blood clots, could be the holy grail in mechanical thrombectomy.
The U.S. Department of Justice reported June 30 that several hundred defendants were charged with health care fraud of more than $14 billion, but the more important news may be that federal agencies are standing up a data sharing system that will make this kind of enforcement more effective.
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
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