As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam. Read More
PARIS – Resilience SAS raised $46 million in a series A round to ramp up European distribution of its mobile application intended for remote monitoring of breast cancer patients, in partnership with the Gustave Roussy Center in Villejuif, France. This funding round was led by two Parisian venture capital funds specializing in digital health – Cathay Innovation SAS and Singular Capital Partners SAS – along with Dutch-based Exor Seeds NV, German-based Picus Capital GmbH and Seaya Capital Gestion, SGEIC, SA, from Spain. Read More
PERTH, Australia – Impedimed Ltd.’s L-Dex bioimpedance technology could quickly become the standard of care for measuring cancer-related lymphedema following clinical trial results that showed a 59% relative reduction in progression compared to the standard of care, Impedimed CEO Rick Carreon told BioWorld. Read More
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER. Read More
A bioelectronic device developed by U.K. startup Ceryx Medical Ltd. has shown potential to restore cardiac performance in preclinical studies. The Cardiff, Wales-based company published data showing its Cysoni technology increased cardiac output by 20% compared to current pacemakers. Read More
The grantmaking process at the U.S. National Institutes of Health has been under scrutiny for several years for several reasons, and a new report by the Office of Inspector General (OIG) indicates that the NIH’s National Cancer Institute (NCI) has generally administered its grants properly. However, the report also indicates that some grantees were tardy in filing their final reports on grant performance, a problem that NCI has vowed to correct with tighter supervision of those grants. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bittium, Boston Scientific, Bonsai Lab, Cell and Gene Therapy, Element Biosciences, Endra, Eurofins, Foundation Medicine, Fujifilm Visualsonics, Genesiscare, Genetic Testing Service JSC, Genetron, Guard Medical, Hutchmed, Labcorp, Merck, Mica Biosystems, Minnetronix, Neuroone, Piur Imaging, Purigen, Quris, Seegene, Technomed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Center for Pain & Stress Research, Esaote North America. Read More
