The U.S. FDA has cleared the way for Abbott Laboratories sixth COVID-19 test, a near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment. The company has priced the Binaxnow COVID-19 Ag Card rapid test at $5 and is offering a complementary mobile app that allows people to display their test results when asked by organizations for verification. Read More
Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test. Read More
LONDON – Ion Beam Applications SA (IBA) has taken a giant step into China, sealing a €100 million-plus (US$118.2 million) licensing deal with a local company to manufacture, install and maintain its proton beam cancer therapy systems. Read More
The U.S. Department of Justice (DOJ) unveiled two interim final rules intended to deal with enforcement activities in connection with policies enunciated over the past four years, including the so-called Brand memo, which banned federal prosecutors from using federal agency guidance as leverage in prosecutions of private-sector entities. Read More
Researchers at Ben-Gurion University of the Negev (BGU) presented a new artificial intelligence technique that could protect medical imaging systems from hacking and human errors at the 2020 International Conference on Artificial Intelligence in Medicine (AIME) on Aug. 26. Their innovative solution uses a dual-layer architecture that screens for two different types of anomalous instructions to capture those that are always unusual or outside of safe ranges and those that are inappropriate in the specific context. Read More
New hires and promotions in the med-tech industry, including: Axol Bioscience, BBS-Bioactive Bone Substitute, Nous Imaging, Novasignal, Valuehealth. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Carl Zeiss Meditech, Eurofins, Tandem Diabetes Care. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amazon, Applied DNA Sciences, Cergentis, Cerner, Emergent Connect, Iron Bow Technologies, Lunit, Natera, Novacyt Group, Owlytics Healthcare, Rewalk Robotics, Statera Spine, Utm:Healthcare, Viewray, Viimed, Vivos, Wenzel Spine. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, B. Braun Medical, Cureapp, Foundation Medicine, Healeon, Med-El, Sanuwave Health. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, FDA, HHS, NICE, Stericycle Expert Solutions. Read More
Keeping you up to date on recent developments in diagnostics, including: A.I. tool promises faster, more accurate Alzheimer's diagnosis; Bioluminescent tool tracks DNA break repair; Mechanisms of retinopathy come into focus. Read More
