Kestra Medical Inc. seems to have put itself in a position to take a bite out of the market for wearable defibrillators with the results of the ASSURE WCD study, which enrolled more than 21,600 patients. The study, whose results were reported on at the American Heart Association annual meeting in New Orleans, demonstrated that Kestra’s unit delivered an inappropriate shock rate of only 0.0065 per patient per month, an outcome that analysts at Wells Fargo said will allow Kestra to close the gap on competitors such as Zoll Medical.
Synchron Inc.'s recent $200 million raise for its Stentrode brain-computer interface platform comes at a pivotal time for the technology. Advances in BCI development, ongoing clinical trials and growing market demand are drawing increased investor interest in the technology which has the potential to transform the lives of millions of people. At the same time, government agencies are closely monitoring the field, recognizing the potential while urging caution about the risks involved.
Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Exact Sciences, Guardant Health, Inbrain, Personalis, Senseonics, Staar Surgical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Tandem, Venus Concept.
UNESCO has adopted the first set of global standards on the ethics of neurotechnology amid the rapid advancement in the development of the technologies and increasing investor interest. These standards, which take effect on Nov. 12, 2025, establish safeguards to ensure that neurotechnology improves the lives of those who need it the most without compromising human rights.
The U.K. Medicines and Healthcare Products Regulatory Agency has laid out an approach to medical products for rare diseases, which the agency said afflict 3.5 million U.K. citizens. One of the objectives of this program is to simplify evidence requirements for these therapies with the hope of providing patients with more rapid access to much-needed therapeutic options.