Researchers affiliated with the U.K.’s University Hospitals Birmingham NHS Foundation Trust filed for protection of a device for treating simple or complex anal or rectovaginal fistulas which is less invasive and more effective than existing treatments. The device combines a bioresorbable scaffold to heal the fistula and a thin comfortable seton to achieve drainage.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ceretrieve, Inspiremd, Predictive Oncology, Sidekick Health, Sight Sciences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Camdiab, Galvanize Therapeutics, Inspira Technologies, Spineart, Toosonix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hitachi, Hyperfine, Opgen, OCT Clinical, Palleos, Radiosurgery Global, Realheart, Roche, Xlife.
Volta Medical SAS reported positive results from the Tailored-AF study which compared its artificial intelligence software-guided ablation procedure in combination with pulmonary vein isolation to a conventional anatomical ablation targeting PVI alone, to treat persistent atrial fibrillation.
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
RSS
