Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. Read More
The U.S. FDA has granted breakthrough device designation to Vapotherm Inc. for its Oxygen Assist Module (OAM), for use with its Precision Flow assistive breathing systems. The new module is designed to aid clinicians in maintaining a targeted blood oxygen range in patients requiring oxygen therapy. Read More
LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care. Read More
The FDA’s device center has resumed a more normal pace of warning letter issuance in recent months, and the latest batch posted to the warning letter website features warning letters to one device maker in Europe and three firms in Asia. One U.S. firm, Steiner Biotechnology LLC, of Henderson, Nev., also received a warning, however, which is the second the company has received since June 2017. Read More
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage. Read More
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection. Read More
Specific therapies against a new disease take time to develop. But there are methods that can speed up that development – and in the meantime, there are ways to make do with what’s already in the cupboard. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Rad, Boston Scientific, Celsee, Center for Medical Interoperability, Ciox Health, Eclipse Automation, Electrocore, Glaukos, Harmontronics Automation, Labcorp, Lantheus, Markforged, Medtronic, Micron Solutions, Neurophotometrics, Nevro, No Borders, Orthofix, Phase Scientific, Quest. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cipla, Diacarta, DNAe, Vapotherm, Silk Medical Aesthetics. Read More
Keeping you up to date on recent developments in diagnostics, including: Using smartphones to detect AF; A study of AI algorithms in mammography assessment; Stopping tau in its tracks. Read More
