A new urine test from Convergent Genomics Inc. correctly predicts bladder cancer as early as 12 years before clinical symptoms occur, new data presented at the 2023 American Urological Association annual meeting shows. The Uroamp test, which can be administered at home and in point-of-care settings, could increase survival rates and help to reduce health care costs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sibel Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akura, Bayer, Bicycle, Emboline, Opsens, Picard, Seastar Medical, Sibel.
Presentations at the Digestive Disease Week 2023 conference highlighted the strong performance of non-invasive tests for early-stage colorectal cancer. Both Guardant Health Inc. and Exact Sciences Corp. aim to increase acceptance of their tests for CRC to drive higher screening rates, as the preparation and invasive nature of colonoscopy continue to depress participation, even as rates of CRC are rising sharply among younger adults.
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
Grand Pharmaceutical Group Ltd. plans to acquire an 87.5% stake in Blackswan Vascular Inc., a company that develops liquid embolism for peripheral vascular applications, as it continues to expand its footprint in tumor intervention.
The U.S. Preventive Services Task Force (USPSTF) is proposing to lower the age of onset of regular breast cancer screening to 40 years, a massive jump of 10 years over the current recommended age of 50 years. While this is just a draft proposal, analysts who track the medical device industry say that medical imaging manufacturers, such as Marlborough, Mass.-based Hologic Inc., could see a significant uptick in demand for their systems, a much-needed boost as the drop in demand incurred by the COVID-19 pandemic comes to an end.
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