Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available. Read More
X-trodes Ltd. has received U.S. FDA 510(k) clearance for its Smart Skin solution, a wireless wearable technology that allows for medical-grade electrophysiological monitoring in clinics and at home. The company believes that the Smart Skin technology, which captures signals from the brain, heart, eyes and muscles, has the potential to significantly improve patient care. Read More
The U.S. FDA’s device center has been prodding industry for some time to develop a culture of quality regarding the manufacture of medical devices, an emphasis that has resulted in the development of several programs. While the recent harmonization of the FDA’s device quality system regulation with an international standard might seem oblique to this culture of quality consideration, the FDA’s Keisha Thomas advised industry that the overhaul of the Quality System Regulation (QSR) is seen inside the agency as part and parcel of that quality push, a statement that seems to suggest that the FDA’s expectations regarding device manufacturing will be more stringent going forward. Read More
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal. Read More
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies. Read More
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now. Read More
New hires and promotions in the med-tech industry, including: CMR Surgical, Cue Health, GT Medical, Hypercore, Mdxhealth, Medtronic, Ocusciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airs Medical, Avance Clinical, Bioptimus, Biosig, Elephas, Lazurite, Lifecore, Medtronic, Owkin, Paragoncare, Ryght. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diacarta, Wellvii, Werfen, X-trodes. Read More
