The 2023 American Society for Clinical Oncology Annual Meeting featured several notable developments on the diagnostics side, including significant advances in multi-cancer early detection (MCED). Grail Inc. presented its results from SYMPLIFY, the first major study of its MCED test in symptomatic patients. The test showed a negative predictive value of more than 97% and a positive predictive value that exceeded 75% in individuals who presented to primary care with non-specific symptoms that prompted a referral for cancer evaluation. Read More
The Fiscal Responsibility Act (FRA) has been signed into law by U.S. President Joseph Biden, heralding a five-year span in which increases in discretionary budget spending will be limited to 1% after a flat funding picture in the coming fiscal year. While the news might seem to portend a flat budget picture for agencies such as the FDA and the National Institutes of Health, a new analysis by the Alliance for a Stronger FDA indicates that congressional intent might at least slightly overcome the limits imposed by the FRA. Read More
Creo Medical Group plc says it is poised to address the mismatch between the advances in screening technology, which are making it possible to detect early-stage lung cancer, and the current invasive and inappropriate methods of treating it, following the first-in-human use of its Microblate Flex microwave ablation device. Read More
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023. Read More
A study of more than a thousand tumor samples, led by the Weizmann Institute of Science in Israel, gives valuable insight into the different gene expression patterns seen in different cancers. The new findings could help address challenges associated with targeting many types of tumors, which are hard to treat in large part due to the variable nature of their cells and gene expression patterns, by helping to create better targeted therapeutics. Read More
New hires and promotions in the med-tech industry, including: Advanced Sterilization, Angle, Electromed, Komodo Health, Medtronic, Miromatrix, Perimeter Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ceres, Biocorp, Clario, Eresearchtechnology, Medtronic, Novo Nordisk, Rockley, Sensydia, Titan. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Masimo, Sparrow Bioacoustics. Read More
