Alpha Tau Ltd. has secured a second breakthrough device designation for its Alpha Dart radiation treatment for solid cancer tumors. The FDA has granted the Jerusalem-based company’s technology a designation for the treatment of patients with recurrent glioblastoma multiforme (GBM), an aggressive malignant brain tumor. GBM has an average five-year survival rate of less than 10% and is the most common malignant tumor of the brain or central nervous system. According to the designation, the Alpha Dart system can be used to treat recurrent GBM as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted. Read More
A pan-cancer liquid biopsy solution that was developed by Twist Bioscience Corp. and Anchordx Medical Co. Ltd. has been launched globally. The companies will market the Twist Alliance Pan-Cancer Methylation Panel (Pan-Cancer Panel) jointly. The Pan-Cancer Panel is a solution for pan-cancer study including DNA methylation library preparation and targeted enrichment for next-generation sequencing (NGS). Read More
Device makers have argued for years that not all medical device recalls are the same, and thus the FDA should be more forthcoming with the public about the difference between a recall that is accompanied by a market withdrawal and a recall that driven by something as innocuous as a minor adjustment to the product label. Read More
The Ernst & Young Pulse of the Industry 2021 report outlined several ways med-tech companies can benefit from fundamental changes in business wrought by the pandemic to build a stronger foundation for the future. While the need for more agile supply chains and the drive to measure social and environmental impact as well as financial metrics have affected all economic sectors, COVID-19 transformed the med-tech industry in specific ways that could have long-lasting impact. Read More
The FDA’s device center has posted a draft guidance that addresses unique device identifier (UDI) code requirements applied to low-risk products. The select update offers enforcement discretion in some instances for class I consumer health products, a switch partly justified by the exceedingly low risk presented by such products. Read More
New hires and promotions in the med-tech industry, including: Foundation Medicine, Iterative Scopes, Personalis, Posieda Therapeutics, Potrero, Sweetch, Tesis Labs. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amra Medical, Certus Critical Care, Charles River Laboratories, Cognitive Medical Systems, Eurofins Genomics, Genedx, Jackson Laboratory, Mynd Life Sciences, Opko Health, Pear Therapeutics, Taysha Gene Therapies, Thornhill Medical, Twist Bioscience. Read More
