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.
Positive results from Limflow SA’s PROMISE II U.S. pivotal trial show its Limflow system for transcatheter arterialization of deep veins (TADV) led to sustained amputation-free survival and wound healing in patients with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. According to the Paris-based company, 76% of CLTI patients who received Limflow therapy were able to avoid an otherwise life-saving major amputation.
Histosonics Inc., the developer of a non-invasive platform that uses sonic beams to destroy tissue, treated the first patient in its phase I study of the procedure as a treatment for kidney tumors at the Leeds Teaching Hospitals National Health Services Trust in the U.K.
Ancora Heart Inc. reported 12-month data showing its Accucinch system significantly improves outcomes in heart failure (HF) patients, including positive changes in cardiac structure and function. The results, presented at the Technology and Heart Failure Therapeutics conference (THT 2023) in Boston, were simultaneously published in the Journal of Cardiac Failure.
New data presented at the Cardiovascular Research Technologies (CRT) 2023 meeting reinforced the safety and effectiveness of Boston Scientific Corp.’s Watchman FLX left atrial appendage occlusion (LAAO) device in routine, real-world clinical care. Building on positive 45-day outcomes presented at CRT 2022, the analysis shows sustained low stroke rate at one year, including ischemic stroke.
Esophageal cancer is often referred to as the “silent killer” because few people show any symptoms until after the cancer has spread. If localized, five-year survival rate is 46%, but that drops to just 5% when malignancy has reached distant parts of the body.
The U.S. FDA has cleared the way for Seastar Medical Holding Corp.. to conduct a pivotal IDE study of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). The Denver-based company plans to begin enrolling patients as early as next month.
Truleaf Medical Ltd., a subsidiary of Israel-based Allmed Solutions, is ready to begin human trials of its Rosedoc platform to replace the heart’s leaky mitral valve using cardiac catheterization.
Volta Medical SAS reported raising $39 million in a series B round to roll out its VX1 software mapping system in Europe and the U.S. This artificial intelligence (AI) algorithm is compatible with most readily available multi-polar catheters and technology used in operating rooms and cath labs in the treatment of complex cardiac arrhythmia.
Women’s health startup May Health SAS has completed treatment of the first five participants in a U.S. feasibility study of its investigational Ovarian Rebalancing technique, a one-time, ultrasound-guided, transvaginal ablation procedure for women with polycystic ovary syndrome (PCOS). The novel treatment is designed to jumpstart the ovaries into releasing mature eggs in normal monthly cycles in women with PCOS-associated infertility.