The Sorin Group recently announced CE Mark approval of its Solo Smart stentless aortic valve, which Milan, Italy-based Sorin is touting as an improvement on its Freedom Solo valve that has been used in Europe since 2004. So how did Sorin ...
Tags: Sorin Group, Solo Smart Valve
US-based Boston Scientific has obtained CE Mark approval for its Vercise deep brain stimulation (DBS) system for the treatment of intractable primary and secondary dystonia. Dystonia is a neurological movement disorder characterized by ...
Tags: Dystonia Treatment, DBS System
Medtronic is touting a potential advance in the cardiovascular space: a recent study that shows some of the smarter algorithms it is using in its pacemakers actually slow the development of atrial fibrillation. The MINERVA study, ...
Tags: Pacemakers, Slow Heart, Rhythm Disorder
CIVCO Medical Solutions, a medical technology company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its EX3 stepper, which is used while performing real time planning for low dose rate (LDR) or high dose ...
Tags: CIVCO Medical, Medicine
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, ...
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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
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 ...
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 ...