Hayward, Calif.-based Reflexion Medical Inc. has received the green light from the U.S. FDA to market its Reflexion X1 system for standard radiation therapy treatments. The company, which also is breaking new ground with the development of biology-guided radiotherapy (BgRT), aims to eventually bring multi-tumor precision radiotherapy to all stages of cancer treatment. The FDA cleared the Reflexion X1 for stereotactic body radiotherapy, stereotactic radiosurgery and intensity modulated radiotherapy. The clearance allows physicians to treat a single tumor with precise beam shaping and radiation dose delivery. Read More
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Read More
Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, Stephen Ferguson, of Bloomington, Ind.-based Cook Group Inc., cited several problems he saw with the draft, including that one of the specifications for balloon fatigue testing exceeds the level spelled out in an international standard adopted by the FDA. Read More
TORONTO – If Toronto’s Sunnybrook Hospital and the W. Garfield Weston Foundation get their way, a CA$33 million (US$24 million) initiative unveiled March 2 dramatically will increase patient access to made-to-measure ultrasound technology for penetrating the blood-brain barrier to treat Alzheimer's disease and brain cancer. Read More
Another volatile day of trading in health care stocks unfolded March 13, after a trebling of broader market carnage the day before and the declaration of a national emergency by U.S. President Donald Trump Friday afternoon. Substantial declines hit shares of Moderna Inc., Vaxart Inc. and Inovio Pharmaceuticals Inc., all of which had recently rallied on optimism over coronavirus-fighting efforts. Biopharma shares saw some recovery, with both the S&P 500 Health Care Sector and Nasdaq biotechnology indices each rising a bit more than 2% each before Friday's close. Read More
PERTH, Australia – On the heels of scoring a CE mark for its Novosorb biodegradable temporizing matrix (BTM) in the EU, Melbourne-based Polynovo Ltd. crossed its first AU$2 million (US$1.3 million) month in December sales for its initial commercial product. Read More
New hires and promotions in the med-tech industry, including: Chembio Diagnostics, Quest Diagnostics, Ra Medical Systems, Second Sight Medical Products. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch Health, Bioreference Laboratories, Cherrycircle Software, Co-Diagnostics, Evisit, Luminex, Medable, MIP Diagnostics, National Kidney Foundation, Opko, Precheck Health Services, Qiagen, Science37, Veravas, Vitalhub. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Reflexion, Roche, Transenterix. Read More
Keeping you up to date on recent developments in neurology, including: Neuexcell Therapeutics sees promise for gene therapy for HD; VR shows promise for early detection of MS balance problems; New findings increase understanding of anorexia nervosa; Study: Surgery with anesthesia not linked to indicator of Alzheimer's. Read More
