Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management. Read More
It has become apparent that introducing two stents into the body to treat a patient with a bifurcation disease is not necessary and can be harmful, David Hildick-Smith, the lead investigator in a study, told delegates at the EuroPCR conference in Paris. Presenting late-breaking clinical data of three-year follow up results of different stenting strategies in patients with true left main stem bifurcation lesions, Hildick-Smith said that the results showed that only one in five patients needed a second stent. Read More
A surgical navigation platform developed by Proprio Inc., that is intended to replace traditional surgical technologies which produce harmful radiation and can impede surgical workflow, won U.S. FDA 510 (k) clearance. Read More
Olympus Europa SE & Co. KG is launching three Endoclot products, two hemostatic agents and a submucosal injection agent, in the Europe, Middle East and Africa (EMEA) region. This new portfolio was developed by Santa Clara, Calif.-based Endoclot Plus Inc., which expanded its distribution with Olympus from the U.S. to EMEA in December 2022. “The addition of their solutions to our portfolio allows Olympus to contribute to safe treatment in gastrointestinal procedures. We aim to improve patient outcomes and hereby elevate the standard of care,” said Stefanie Kaufung, EMEA business unit manager gastrointestinal endotherapy at Olympus. Read More
Implanting brain organoids into the brains of mice may allow the more realistic study of microglial cells during both healthy and disease states. This is what researchers from the Salk Institute and their collaborators found in a study published on May 11, 2023, in Cell. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: C2Sense, Cook Medical, Electromedical, GI Medical Innovations, Janssen Pharmaceuticals, Onward, Pulvinar Neuro, Princeton Biomedtech, Sonothera. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, BD, Linear Health Sciences. Read More
