Vagus nerve stimulation (VNS) researchers notched another success with FDA approval of a drug-free rehabilitation system that uses the technology to help patients who have lost mobility in their hands and arms as a result of ischemic stroke regain function. Microtransponder Inc.’s Vivistim pairs rehabilitation exercises with VNS to enhance their impact. The clinical study evaluated by the FDA for the system's approval showed that Vivistim doubled the improvement in upper extremity motor function compared to supervised rehabilitative exercises alone at six weeks and 90 days. Read More
The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option. Read More
Helius Medical Technologies Inc. has received an FDA breakthrough device designation for its Portable Neuromodulation Stimulator (Pons) device for temporary treatment of dynamic gait and balance deficits due to stroke. Read More
The use of voice recognition systems based on artificial intelligence (AI) in health care is emerging in India, which offers a potentially enormous market, according to Scribetech Healthcare (India) Pvt. Ltd., one of the leading voice recognition companies in the country. Read More
Investigators at MIT have identified a protein capable of delivering its own mRNA to cells, and engineered that protein to deliver mRNA sequences of their choosing. In a mouse model, the team used their approach to deliver the mRNA for two different proteins. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Biomatrix, Bico Group, Cellink, (Georgia) Global Partnership for Telehealth, Humacyte, Lazurite Holdings. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Microtransponder. Read More
