Viewray Inc., the manufacturer of the Mridian MR-guided radiation therapy system, released disappointing preliminary first quarter 2023 results and shareholders braced for more bad news as the company reported it engaged Goldman Sachs to evaluate strategic alternatives including corporate sale, merger or business combination.
Tessara Therapeutics Pty Ltd. is developing a technology platform that builds three-dimensional models of the human brain to treat neurological diseases such as Parkinson’s disease. Read More
Developers of clinical decision support (CDS) software have their hands full with a recent U.S. FDA final guidance on these products, but the picture promises to become more byzantine with the publication of a draft rule by the Office of the National Coordinator (ONC). The new ONC proposal would require a demonstration of transparency for decision support intervention (DSI) predictive functions in order for that software to qualify for ONC certification, a requirement that might not overlap neatly with the FDA’s own transparency requirements. Read More
Diabeloop SA reported a partnership with Novo Nordisk A/S. The med-tech is planning to integrate DBL-4pen, its self-learning algorithm for multiple daily injection therapy, into Novo Nordisk's connected, reusable insulin pens: Novopen and Novopen Echo Plus. “Our partnership is designed to deliver more automated solutions to people with diabetes, optimizing outcomes and improving quality of life,” Cecile Ferracci, CCO of from Grenoble, France-based Diabeloop, told BioWorld. Read More
Phenomix Sciences Inc. has launched a first-of-its-kind test that could provide precision medicine treatment options for patients suffering from a particular form of obesity. Key to the saliva-based Hungry Gut test for patients still hungry after eating is the science of phenotyping enabling specialists to determine genetic sources for this and other distinct obesity conditions. Read More
Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master files for sterilization of medical devices. This program is for single-use PMA devices only made by nine companies and allows the manufacturer or sterilizer to document the switch to radiation sterilization with an expedited review process. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clinical Laserthermia Systems, Neuronetics, Tivic Health Systems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetesis. Read More
