Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections. Read More
Perspectum Diagnostics Ltd. reported the first close at $36 million of its series C round, with the majority of the new money due to be invested in expanding U.S. uptake of its Livermultiscan diagnostic for assessing and monitoring chronic liver disease. Read More
The COVID-19 pandemic provided opportunities for companies that provide telehealth solutions, and Taiwan-based Faceheart Inc has developed video-based measurement software that allows patients to be screened remotely using artificial intelligence (AI). Read More
Bringing notified bodies (NBs) into a med-tech regulatory system has proven to be no mean feat in the European Union, but the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) seems not to suffer from such impediments. The agency just added several in vitro diagnostic (IVD) technological areas to the roster of tests that can be reviewed by UL International UK, an addition that will help ensure patients can obtain the tests they need. Read More
The U.S. FDA has posted yet another two regulations for devices granted market access via the de novo petition program, one of which addresses dry eye by means of pulsatile light emissions. This device may serve as a predicate for many 510(k) devices if estimates of prevalence in the tens of millions in the U.S. are any indication. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Novorad, Siemens Healthineers, Sientra, Surmodics, Tanaka, Varian Medical Systems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Conventus Flower. Read More
