A group of stakeholders including medical device makers have penned a letter to Centers for Medicare & Medicaid Services administrator Mehmet Oz to urge the agency to cover breakthrough medical devices, an attempt to resurrect administrative action on a question that legislators failed to address in 2024.
Neurovalens Ltd raised £6 million (US$8 million) in an investment round for its non-invasive neurostimulation devices, which treat insomnia and manage anxiety. The company will use the funds to expand its presence in the U.S. and accelerate sales of its U.S. FDA-cleared devices, Modius Sleep and Modius Calm. The round was led by the Investment Fund for Northern Ireland (IFNI) with support from new and existing investors.
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Neurolief.
No matter what level of tariff the Trump administration ends up imposing on biopharmaceuticals across the world, drugs and their precursors originating in the EU will face no more than a 15% tariff when imported to the U.S., according to an Aug. 21 EU-U.S. joint statement regarding the trade framework agreement between the two trade partners.
Cohesys Inc. conducted the first test of its resorbable Bonetape in humans as part of an investigational trial for craniofacial fractures. The tape could eliminate the use of drills and screws in many plastic and reconstructive facial surgeries, potentially simplifying procedures and recovery.
Stimvia s.r.o.’s Uris system, which delivers peroneal electrical transcutaneous neuromodulation, successfully treated the symptoms of Parkinson’s disease. The non-invasive device, originally developed to treat overactive bladder, safely reduced tremors and improved the quality of life of the patients suffering from Parkinson’s.
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