Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function. Read More
Dead cancer cells in the body are thought to help trigger an active immune response in oncology patients, particularly in combination with immunotherapy drugs. Some technologies, such as radiation and laser therapy, that kill cancer cells are being investigated for use in combination with immunotherapies. Well-regarded oncology specialist The University of Texas MD Anderson Cancer Center has partnered with Rakuten Medical Inc. to further advance one such technology, the latter’s photoimmunotherapy platform Illuminox. Read More
PARIS – Robocath SAS, of Rouen, France, has secured a new $43 million funding round to boost roll-out of its R-One robotic system for treating vascular disease. This series C funding was led by Hong Kong-based Microport Scientific Corp. Read More
The U.S. FDA’s effort to marry its quality systems regulations with ISO 13485 has hardly gone off without a hitch, but Melissa Torres, director of international programs at the FDA’s device center, said the agency is “very hopeful” it can publish a draft rule for that task by the end of this year. Read More
Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arbor Vita, Cambridge University Hospitals, Cancer Research UK, Crh Medical, Flir, Geisinger, Gerpang Healthcare Group, Hypertension Diagnostics, Mainstay Medical, Makemedical, Nano-X Imaging, Promedica Bioelectronics, Rti Surgical, Siemens Healthineers, Spo Global, Xoran. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chembio Diagnostics, Edwards, Genetron Health, Laminate Medical Technologies, Nuvaira, Surmodics. Read More
Keeping you up to date on recent developments in cardiology, including: Stroke protection effects like night and day; Blood pressure meds help range of patients when taken as prescribed; Test IDs undetected blood clots in COVID-19 patients. Read More
