US-based LabStyle Innovations has obtained CE Mark approval for its Dario smartphone-based glucose monitor and comprehensive diabetes management system. Particularly useful for insulin-dependent patients, the system provides patients, ...
US-based Sapheon has submitted the first module of pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its VenaSeal sapheon closure system, designed to treat venous reflux (varicose veins) disease. This ...
Tags: PMA Application, Medicine
Abbott, a global healthcare company, has obtained CE Mark approval for its FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System, designed to support daily diabetes management. The FreeStyle Optium Neo system has a high contrast ...
German-based JenaValve Technology has obtained CE Mark approval for its transapical transcatheter aortic valve implantation (TAVI) system, designed to treat aortic insufficiency (AI). AI, also known as aortic regurgitation, is a condition ...
The Israeli Ministry of Health has granted an approval to Medigus for registering its SRS system, which is designed to treat gastroesophageal reflux disease, in the Israeli Register of Medical Equipment and Accessories (MEA). The SRS ...
Tags: SRS system, Medicine
Dfine, a manufacturer of spinal disease treatment devices, has obtained CE Mark approval for its STAR tumor ablation system, designed to treat painful metastatic spinal tumors. The STAR tumor ablation system uses radiofrequency (RF) ...
Tags: Dfine, Tumor Ablation System
Sweden-based medical technology company Aerocrine has launched the NIOX VERO device, designed to measure the airway inflammation, such as asthma. Aerocrine and Panasonic Healthcare have jointly developed the new fully portable hand-held ...
Tyber Medical, a developer of spine and orthopaedic devices, has received CE Mark approval for its TyPEEK, a titanium plasma sprayed PEEK interbody system. The highly differentiated proprietary titanium plasma sprayed TyPEEK offers ...
US-based Moirai Orthopaedics has obtained CE Mark approval for its new Pyrocarbon Implant Replacement (PIR) system, designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. The ...
Keystone Heart, a developer and manufacturer of cerebral protection devices, has received CE Mark approval for its TriGuard cerebral protection device, designed to cover all three aortic cerebral branches to minimize the risk of cerebral ...
Tags: Keystone, Protection Device
Tenaxis Medical, a developer of high-performance sealants, has received approval to expand its CE Mark indications for ArterX surgical sealant, from its EU notified body, BSI. ArterX Surgical Sealant is specifically designed to be applied ...
US-based Fujifilm SonoSite received CE mark approval for its X-Porte ultrasound kiosk, a new generation of point-of-care ultrasound. This integrates advanced signal processing for high-resolution imaging, 3D animated clinical guides, and ...
Tags: SonoSite, Ultrasound Kiosk
Preventice, a developer of mobile health applications and remote monitoring systems, has received ISO 13485: 2003 certification for its quality management system. As per the ISO requirements of the quality management system, an ...
Tags: Preventice, health applications
Coherex Medical, a developer of medical devices, has obtained CE Mark approval for its Coherex WaveCrest left atrial appendage (LAA) occlusion system. WaveCrest LAA Occluder seals off the LAA opening so that blood clots cannot escape into ...
Tags: Coherex Medical, CE Mark
Avinger, a manufacturer of multifunctional catheters, has received CE Mark approval for Pantheris, a lumectomy catheter designed to remove the blockage while avoiding the disruption of normal arterial wall structures. This lumivascular ...