Orchestra Biomed Holdings Inc. randomized the first patient in the BACKBEAT pivotal study investigating the use of its atrioventricular interval modulation (AVIM) therapy as a treatment for patients with uncontrolled hypertension implanted with a Medtronic plc pacemaker. AVIM therapy is an investigational patented bioelectronic therapy designed to immediately and durably reduce blood pressure. Read More
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment. Read More
Researchers from the University of Auckland have developed a smartphone app called Mindear that reduced the impact of tinnitus in two-thirds of users over eight weeks.Tinnitus, often referred to as ringing in the ears, is the perception of sound without an external source and affects 10% to 15% of the global adult population. Previous studies to treat tinnitus have focused on neuromodulation devices, but a smartphone app could make treatment more accessible to a wider population. Read More
Industry may still be less than fond of the failure of the term “recall” to distinguish between corrections and market withdrawals, but the class I recall of the Insulet Omnipod 5 app for Android smartphones is a correction of some importance. This recall, one of the first to be announced by the FDA in 2024, addresses a software problem that could lead to overdose of insulin, a potentially lethal problem for which the company has already provided a fix. Read More
Lumitex Inc. seeks patent protection for a phototherapeutic apparatus for treating inflammatory conditions, with a particular focus on treating acute respiratory distress syndrome. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M Co., 3Spine, Abbvie, Akoya, Astek Diagnostics, Bone Biologics, Boston Orthotics, Caris, Chromacode, Concertai, Danaher, Dnanexus, Embecta, Endeavor Health, Genomicmd, Mediwound, Microsoft, Nevro, Orthopediatrics, Stryker, Thermo Fisher, Ultromics, United We Care. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurolief, Pulsenmore, Providence Medical. Read More
