Liquid biopsy startup Thrive Earlier Detection Corp. has raised $257 million in a series B round led by Casdin Capital and Section 32. The funds will be used to finalize the design of its first product, Cancerseek, conduct a trial to support U.S. FDA approval and prepare for commercialization. Read More
The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.” Read More
Startup Scipher Medicine, of Waltham, Mass., is developing a blood test to predict which rheumatoid arthritis (RA) patients will not respond to Tumor necrosis factor (TNF) inhibitor therapies. Read More
VANCOUVER – Sorrento Therapeutics Inc., which is working to build a comprehensive lineup of COVID-19 products, has in-licensed a self-contained test for SARS-CoV-2 that may produce accurate results in half an hour. Read More
HONG KONG – Los Angeles-based nonprofit accelerator Medtech Innovator has teamed up with the Asia Pacific Medical Technology Association (APACMed) and picked 20 companies to participate in the organization’s Asia Pacific Accelerator program. With the competition in its eighth year, the accelerator also has revealed that Johnson & Johnson Medical Devices has committed to be a sponsor of the program for the next three years. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hai Kang, Philips, Sinapi Biomedical, Truvian. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex, Image Processing Technologies, Smith & Nephew. Read More
Keeping you up to date on recent developments in orthopedics, including: Lego-inspired bone and soft tissue repair with tiny, 3D-printed bricks; Mutant zebrafish reveals a turning point in spine's evolution; Newly discovered cells act as a warning signal for rheumatoid arthritis flares. Read More