Danish medical device company FBC Device has obtained CE Mark approval for its Statur-L, a spinal fusion implant. FBC Device has also obtained International Organization for Standardization certification for maintaining highest quality ...
OrSense, a developer of solutions for non-invasive measurements of various blood parameters, announced that it has received the US Food and Drug Administration clearance for its NBM-200MP, noninvasive hemoglobin (Hb) and pulse oximetry ...
Tags: Orsense, FDA Clearance
Germany-based biomedical technology company Biotronik has obtained CE Mark approval for its PK Papyrus covered coronary stent system for use in the treatment of acute coronary artery perforation. According to Biotronik, the company's PK ...
Tags: Coronary Stent System, Medicine
US-based Seventh Sense Biosystems has obtained CE Mark approval for its Touch Activated Phlebotomy (TAP) blood collection and testing system. Seventh Sense Biosystems' TAP painless blood collection platform allows the collection of ...
Tags: Phlebotomy Platform, CE Mark
LabStyle Innovations, the developer of Dario, has announced the official European launch date for the Dario iOS mobile application. Dario is a cloud-based, mobile health (mHealth) platform for diabetes and related blood glucose ...
Transgenomic, a global biotechnology company, and US-based PerkinElmer have entered into a collaboration agreement for marketing and distributing Transgenomic’s line of molecular diagnostic oncology products in territories outside the ...
US-based Elixir Medical has announced positive one-year results from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, fully bioresorbable DESolve Novolimus eluting coronary scaffold system. At one year, the ...
Tags: Elixir Medical, NX Clinical Trial
DJO Surgical, a DJO Global company, has reported the first surgical use of its patient-specific shoulder instrumentation, Match Point System, in Reverse shoulder system cases in Australia and Florida. Developed in collaboration with ...
US-based medical device company Vycor Medical has announced the issuance of a new patent in Australia for its NovaVision vision restoration technology. The new Australian patent is for visual testing methods that fixate the user's gaze ...
Tags: Vycor Medical, medical device
UK-based GlySure has completed patient enrollment for the multicenter CE Mark trial of its in-hospital continuous blood glucose monitoring (CBGM) system. The trial, led by principal investigator Dr Krishna Prasad, comprised 30 post ...
Tags: CE Mark Trial, Glysure
AngioDynamics, a medical device company, has obtained CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for around six hours. The CE Mark also covers the ...
Tags: AngioDynamics, Angiovac
US-based Boston Scientific has obtained CE Mark approval for its Lotus valve system, a transcatheter aortic valve replacement (TAVR) device designed to treat patients with severe aortic stenosis who are at high risk with surgical valve ...
Tags: Lotus Valve System, Health, Medicine
US-based Abbott Laboratories has obtained an approval from the US Food and Drug Administration (FDA) for its MitraClip device, designed to treat patients with significant symptomatic degenerative mitral regurgitation (MR) who are at ...
Tags: FDA Approval, Abbott
Sphere Medical, a developer of monitoring and diagnostic products for the critical care setting, has successfully completed an extensive Proxima system usability study at the Queen Elizabeth Hospital, Birmingham, UK. These positive ...
Colibri Heart Valve announced that patient enrollment has concluded in the first-in-human study of the Company's transcatheter aortic valve implantation (TAVI) system in the Dominican Republic trial site. Analysis of the data from ...
Tags: Colibri Heart Valve, Tavi System