The U.S. FDA granted de novo marketing authorization to Interscope Inc.’s Endorotor system for direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis, giving the specialty device a cutting edge over more generic tools often used for the challenging procedure. Endorotor received a CE mark for this indication in 2018 and also has FDA 510(k) clearance for post-endoscopic mucosal resection tissue persistence with a scarred base and for removal of endobronchial tumors and granulation tissue. Read More
LONDON – The life sciences industry exhaled sharply and prepared to labor over the fine print in 1,246 pages of text after the EU and U.K. reported they had agreed a post-Brexit trade deal on Christmas Eve. The U.K. has said it will take a light touch, at least initially, with implementation of new border controls taking place in three stages up to July 30, 2021. The EU has not said what its approach will be. Read More
Telehealth has been topical in the U.S. for several years now, but the COVID-19 pandemic lent new urgency to the question of Medicare coverage. However, there are a number of related enforcement issues that could dampen adoption and increase the legal risk for both health care professionals and developers of telehealth-related products. Read More
While several companies are looking to help recurrent glioblastoma patients, Carthera SAS has taken a step forward by bringing its Sonocloud-9 device into a phase I/II clinical trial. Northwestern University in Chicago will collaborate with the company in the trial, which is expected to enroll up to 39 patients. The first patient already has been treated. Read More
Two-Photon Research Inc. (TPR) has launched a diagnostics platform it said improves coronavirus detection via aptamers, small molecules that change shape when binding to a protein at the surface of the SARS-CoV-2 molecule that causes COVID-19. Light shone onto a vial containing a patient’s saliva and the Aptamer Molecular Photonic Beacon (AMPB) generates negative or positive results that are instantly displayed on a smartphone and stored for planning purposes by public health officials. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Visionquest, Zetroz Systems. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDCG posts guidance agenda for 2021; CPC comments on FDA’s skin biocompatibility draft. Read More
Keeping you up to date on recent developments in orthopedics, including: What’s the ‘true’ rate of dislocation after total hip replacement?; A human gene placed in fruit flies reveals details about a human developmental disorder; Life expectancy and health care costs for patients with rheumatoid arthritis. Read More
