Boston Scientific, a medical device company, has obtained the US Food and Drug Administration clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to facilitate selective access and delivery of diagnostic, ...
Tags: Boston Scientific, Microcatheter
Avedro (Waltham, MA) landed a CE Mark in the European Union for its non-surgical myopia treatment device. The device, dubbed KXL II, can perform a photorefractive intrastromal cross-linking procedure, allowing for the correction of myopia. ...
Tags: Myopia Treatment Device, CE Mark
Boston Scientific has reported the first two commercial implants of Lotus valve system in a German hospital. Dr Gerhard Schuler and Dr Axel Linke led the procedures at the Heart Center - University Hospital Leipzig, Germany. CE Mark ...
Tags: Boston Scientific, Lotus Valve
W. L. Gore & Associates (Gore) has announced that Dr Brian Peterson from Saint Louis University, enrolled the first patient in the Gore EXCLUDER iliac branch clinical study. The clinical study is a prospective, multi-center, ...
Tags: Medicine, Gore Excluder
Hologic, a manufacturer of diagnostic and medical imaging systems, has obtained Health Canada approval for its Aptima HPV assay for use on the company's fully automated Panther system. Aptima HPV assay has been designed to detect ...
Tags: Health Canada, Aptima HPV Assay
France-based Synapse Biomedical has obtained the Health Canada approval for its NeuRx diaphragm pacing system (DPS) for ventilator-dependent spinal cord injury (SCI) patients who lack voluntary control of their diaphragms. Synapse ...
Tags: Synapse Biomedical, Neurx DPS
US-based Bruin Biometrics has obtained CE Mark approval in the EU to market its SEM scanner, a class IIA medical device intended to detect pressure ulcers before they show up on skin's surface. The hand-held device is intended to detect ...
Tags: SEM Scanner, hand-held device
Canada-based Titan Medical has recently commenced tissue testing that was successful in assessing and measuring the functionality of the SPORT (single port orifice robotic technology) surgical system. The company will perform a sequence ...
NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has announced the availability of the nCounter Dx analysis system for high-complexity, CLIA-certified laboratories. ...
Tags: NanoString, DX Analysis System
The Netherlands-based Royal DSM has announced a partnership with US-based BiO2 Medical to supply DSM’s proprietary ComfortCoat lubricious coating and its coating application expertise for use in BiO2 Medical’s Angel catheter. ...
W. L. Gore & Associates (Gore) has obtained CE Mark approval for its GORE EXCLUDER iliac branch endoprosthesis, designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. Gore has designed the iliac ...
Tags: CE, Gore, GORE EXCLUDER, product line
US-based medical device company Veniti has obtained CE Mark approval for its Veniti Vici venous stent, designed for venous obstruction treatment. The company has also obtained CE Mark approval for its Veniti Veni RF plus ablation system, ...
Tags: venous obstruction treatment, varicose vein ablation product, heal
Seventh Sense Biosystems (Cambridge, MA) landed CE Mark approval in the European Union for its Touch Activated Phlebotomy platform. The platform is designed for blood collection procedures and is slated for release in one year or more. For ...
Medtronic has obtained an investigational device exemption from the US Food and Drug Administration (FDA) to initiate SYMPLICITY HTN-4 clinical trial using its Symplicity renal denervation system. SYMPLICITY HTN-4 study has been designed ...
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