One Lambda, a part of Thermo Fisher Scientific, has obtained CE Mark approval for its C1qScreen assay in Europe. Utilizing Luminex-based single antigen beads, the C1qScreen solid-phase assay allows clinicians to further characterize ...
Tags: One Lambda, C1qscreen Assay
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 ...
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
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
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
Baxter International has announced the introduction of HEMOPATCH sealing hemostat, a collagen-based resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is ...
PLC Systems, a medical device company, has obtained an approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to initiate a single-arm clinical trial in Japan using its RenalGuard therapy. This approval is based on MHLW's ...
Tags: PLC Systems, Renalguard Therapy
US-based Pulsar Vascular has obtained CE Mark approval for its PulseRider device, designed to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy. With this CE Mark approval, the company now has full ...
Tags: Pulsar Vascular, CE Mark Approval
St. Jude Medical, a global medical device company, has completed the acquisition of Nanostim, a developer of miniaturized, leadless pacemakers. St. Jude Medical and Nanostim have entered into a series of agreements in May 2011, pursuant ...
Tags: St.Jude Medical, medical device
US-based OrthoSensor has announced its plans to launch its Verasense knee system in European markets after recently receiving CE Mark approval. US-based OrthoSensor has announced its plans to launch its Verasense knee system in European ...
Tags: Verasense Knee System
Shanghai MicroPort EP MedTech, a wholly-owned subsidiary of Shanghai MicroPort Medical Group, has obtained CE Mark approval for its Columbus 3D EP navigation system, indicated for the diagnosis and treatment of complex arrhythmia diseases. ...
Actuated Medical, a US-based medical device company, has obtained the additional US Food and Drug Administration (FDA) approval for its TubeClear system. The company has added several new clearing stem models for the TubeClear system and ...
Tags: Actuated Medical, medical device
Medtronic, a US-based manufacturer of implantable heart-rhythm devices, has obtained the US Food and Drug Administration (FDA) approval for the Complete SE (self-expanding) vascular stent for use in superficial femoral artery (SFA) and ...
Tags: Medtronic, Lower Extremities