Tissue Regeneration Technologies LLC (TRT) has nabbed U.S. FDA 510(k) clearance of its Orthogold 100 device for the treatment of superficial burns. The patented Softwave technology uses an unfocused extracorporeal shock wave to spur a physical and biological response that aids in wound healing. The FDA cleared the device for the treatment of superficial, partial-thickness, second-degree burns in adults. Read More

The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic. Read More

As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. Read More

Vessi Medical Ltd. has scooped up $1.7 million in series A funding to move forward with a first-in-human study of its minimally invasive bladder cancer device. The trial is set to launch in the first quarter of 2021. Leading the funding round are the Trendlines Group Ltd. and Agriline Ltd. The Trendlines Group already counts Misgav, Israel-based Vessi Medical as part of its portfolio of medical startups. Read More

Natera Inc.’s personalized, tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, accurately and quickly predicted response to immunotherapy across 25 types of cancer, in a study published in Nature Cancer. Read More

New hires and promotions in the med-tech industry, including: Activ Surgical, Akoya Biosciences, Biom’up France, Castle Biosciences, Guerbet, Immunovia. Read More

Med-tech firms raising money in public or private financings, including: Kitotech Medical, Miracor Medical. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Base10, DNA Link, Opgen, Sintx Technologies. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abingdon Health, Archimed, Avacta, Baylis Medical, Biomx, Bionano Genomics, Bioreference Laboratories, Bioventrix, Boca Radiology Group, Boehringer Ingelheim, Clarify Medical, Concept Medical, Diagnostic Centers of America, Endologix, Evotec, Fujitsu, Immunecyte, Mazzetti, Medtronic, Namsa, Oncimmune Holdings, Opko Health, Pangea, Promega, Radioisotope Life Sciences, Screenpoint Medical, Smartpharm Therapeutics, Sorrento Therapeutics, Thermogenesis Holdings, Todos Medical, Vibrent Health, Vivalnk. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biohit, Cardiac Dimensions, Detectachem, Exsomed, Pq Bypass, Tissue Regeneration Technologies. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BloodPAC, Refocus Group. Read More

Keeping you up to date on recent developments in orthopedics, including: Implant choice more important than surgeon skill for hip replacement success; Vertebral body tethering shows clinical success as treatment for scoliosis; Hip fracture risk linked to nanoscale bone inflexibility; Bioventus reports first use of its Signfuse bioactive bone graft in strip format. Read More