M.A. Medalliance SA has been awarded a de novo investigational device exemption (IDE) by the U.S. FDA for its sirolimus-eluting balloon. This approval is subject to initiation of a pivotal clinical trial in the U.S.
Bottneuro AG closed the first tranche of a bridge round, bringing its total capital raise in 2022 to $4.3 million. This is being used to develop its noninvasive, domestic therapy for treating early moderate-stage Alzheimer’s patients.
Earlysight SA is developing a novel ophthalmology device that can be used to diagnose certain degenerative eye disorders long before onset of first symptoms. Earlysight and researchers at the Swiss Federal Institute of Technology Lausanne (EPFL) have reported positive results for their first clinical trial of Cellularis in the journal Ophthalmology Science.
Onward Medical NV reported clinical outcomes for the first 10 patients given therapy to regulate blood pressure using its implantable ARC technology. This pulse generator produced an immediate improvement in blood pressure regulation in all study participants.
Switzerland is making moves to allow the import of U.S. FDA-approved medical devices after losing barrier-free access to the EU market and over rising concerns about the dismal pace of implementation of the EU’s upgraded devices regulations.
Vaudois University Hospital (CHUV), in conjunction with the European laboratory for particle physics (CERN) and Theryq SAS, has signed an agreement to develop equipment for a novel radiotherapy technique known as “electron Flash therapy.” The new device will use very high energy electron (VHEE) radiation to treat cancers resistant to conventional therapy.
A team from the University of Geneva (UNIGE) in Switzerland and the Ludwig Maximilian University of Munich in Germany has succeeded in developing a fully biodegradable nanoparticle able to deliver a new anti-inflammatory drug directly into macrophages where an uncontrolled inflammatory response has been triggered.
Samantree Medical SA has published clinical data demonstrating a significant reduction in re-operations in breast-conserving surgery using its novel ultra-fast confocal microscopy technology. The study on its medical imaging platform, the Histolog scanner, has just been published in The Breast.
The new EU Medical Devices Regulation (MDR) is not going down well with Swiss medical technology manufacturers. At a conference held on Oct. 19 in Bern, Switzerland on introducing the new EU MDR, the Swiss medical technology association, Swiss Medtech, which represents more than 700 firms, put out a harsh and definitive statement.
Cascination AG reported the first thermal ablation of liver tumors to be performed in France using its CT-guided stereotactic planning and navigation system, CAS-One IR. The technology was used at Dijon Bourgogne University Hospital, where a dozen procedures have been carried out in the Department of Diagnostic and Therapeutic Radiology.
