Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Capsovision, Complete Genomics Fastwave, Knight Therapeutics, Profound Medical, Sectra, Sophia Genetics, Surmodics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sterotaxis, Zap Surgical.
Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7% in Nov. 10 trading.
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.