Grail Inc. reported on June 4 the first results of its Pathfinder study evaluating its assay for the early detection of 50 cancers, showing a positive predictive value of 44.6%. With a total of 6,629 study participants across more than 140 clinical study sites, the blood test is supported by what the health care company believes to be the “largest clinical study program in genomic medicine.” Read More
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery. Read More
Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) will begin accepting applications from domestic companies to become conformity assessment bodies (AU CAB) beginning July 1. The aim is to allow approved Australian corporations to issue conformity assessment certification for medical devices under Australian law to align with the country’s essential principles. Read More
The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.” Read More
Suzhou-based Intocare Medical Technology Co. Ltd. raised up to ¥100 million (US$15.66 million) in a series D funding round led by Qiming Venture Partners. Oriza Holdings, Oriza FOFs and Yuanbio Venture Capital also participated in the round. The company said the proceeds would be used for product R&D, clinical research, marketing promotion, and the launch of new offices and production sites. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angle, China Resources Pharmaceutical Commercial Group Medical Devices, Cigna, Dinova Medtech, Hologic, Marathon Medical, Peijia Medical, Pixalere Healthcare, Sanara Medtech, Sky Medical Technology, Vela Diagnostics, Veracyte. Read More
