The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation. Read More
The COVID-19 pandemic has thrown a wrench in routine medical exams, scaring many patients away from in-clinic visits and diverting resources to coronavirus-related needs. For pregnant women, who require frequent checkups but don’t want to risk infection, this can be a particularly trying time. Now, Israeli startup Pulsenmore Ltd. has launched a hand-held device that lets women perform ultrasounds in their own home and relays the results to a doctor or sonographer for evaluation and feedback. Read More
The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry. Read More
PERTH, Australia – As the state of Victoria in Australia records its deadliest day since the COVID-19 pandemic began, reporting 17 deaths and 394 new cases, Atomo Diagnostics Ltd.’s new COVID-19 antibody test could ease pressure on health care systems. Read More
Sight Diagnostics Ltd. raised $71 million in series D financing to expand its commercial operations and increase research and development efforts into disease detection from its fingerprick blood analyzer Sight OLO. Read More
Investigators have developed a new approach to classifying neurodegenerative disorders that used the overall patterns of protein aggregation, rather than specific proteins, to define six clusters of patients that crossed traditional diagnostic categories. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Borqs Technologies, Fujifilm Sonosite, Hoth Therapeutics, Mallinckrodt, Sight Sciences, Spectral Medical, Sysmex America, Siemens Healthineers, Thermo Fisher Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helix, Nanotronics Health. Read More
Keeping you up to date on recent developments in cardiology, including: Mutation could hint at heart disease therapeutic target; Nanoparticle system captures heart-disease biomarker; Helping predict chest pain in those with heart disease. Read More
