Sotera Health Holdings LLC has finalized a $408 million settlement for litigation over the company’s use of ethylene oxide (EtO) at a Sterigenics facility in Willowbrook, Ill., although litigation is still pending in connection with sites in other U.S. states. The news comes as med-tech trade associations register their disappointment with an EPA proposed rule for EtO that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (Advamed) argue would crimp availability of sterilization capacity, which would in turn create shortages of medical devices and supplies that are desperately needed by patients.
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path.
At the American Diabetes Association (ADA) Annual Meeting this weekend, Medtronic plc provided an update for investors and showcased results from its devices that all demonstrated better time in range for users. The Dublin-based company provided strong results with the U.S. FDA warning letter now behind it and the 780G Minimed pump and Guardian 4 sensor launches well underway.
Carthera SA raised €37.5 million (US$40 million) in a series B funding round that will allow the company to embark on the first pivotal trial of its Sonocloud technology. The Sonocloud-9 is the only implantable ultrasound device that can repeatedly open the blood-brain barrier and deliver effective treatment in patients with recurrent glioblastoma, Frédéric Sottilini, CEO of Carthera, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical IP.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Accuray, Accyourate, Baird Medical, Betters, Cerevasc, Collplant, Escala Medical, Engineering, Femasys, Lianmedical, Prenetics, Techsomed.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Blue Earth Diagnostics, Dariohealth, Medtronic, Reflexion Medical.
The U.S. Office of Inspector General (OIG) has concluded an analysis that found fault with Medicare payments for genetic testing under CPT code 81408, a code that covers tests for a variety of mutations of medical interest. According to OIG, these claims were often paid $2,000 each despite poor oversight from Medicare administrative contractors (MACs), raising the risk that a substantial percentage of roughly $888 million in claims paid between 2018 and 2021 were either fraudulent or at best inappropriate.
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