c has submitted 510(k) application to the U.S. Food and Drug Administration (FDA) for marketing clearance of its MicroCutter XCHANGE 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical ...
Tags: Microcutter Device
Hansen Medical has enrolled first patients for ARTISAN-AF clinical trial to evaluate the use of Artisan family of control catheters with its Sensei X robotic catheter system for treatment of atrial fibrillation. The robotic catheter ...
Tags: Hansen Medical, Clinical Trial
IMRIS has obtained CE mark for its specialized multifunctional surgical theater called VISIUS iCT, designed for spinal and neurosurgical needs. Claimed to be the first ceiling-mounted intraoperative CT solution available in the market, ...
Tags: CE Mark, CT Solution
Stryker Interventional Spine has received 510(k) clearances from the US Food and Drug Administration (FDA) for Venom RF cannula and electrode combination and11g iVAS balloon system. The Venom RF cannula and electrode combination contains ...
Integra LifeSciences has received US regulatory clearance to market its Integra Titan Reverse Shoulder System, which offers greater flexibility for shoulder replacement surgery. The company plans to begin a limited market release in the ...
Tags: Integra Lifesciences
US medical device company TriVascular has commenced the US Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation System and the Ovation Prime System ...
Tags: TriVascular, medical device
Hydromer and the Russian Cardiovascular Catheter company have entered into an agreement, under which the Russian firm is licensed to use the Hydromer hydrophilic coating on its percutaneous transluminal coronary angioplasty (PTCA) ...
Tags: Russian Firm, PTCA Microcatheters
Israel-based Given Imaging has secured regulatory clearance in Japan for its PillCam COLON, a video capsule that can help in the diagnosis of colonic disease in patients who are unable or unwilling to undergo colonoscopy. Given Imaging ...
Tags: Given Imaging, Capsule
CryoLife has received premarket approval from the US Food and Drug Administration (FDA) for its new Sologrip, a minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset ...
Luna Innovations, a developer of new-generation products for the healthcare market, has entered into a multi-year distribution and supply agreement with Intuitive Surgical. The supply agreement, which has been amended, provides for ...
Tags: Intuitive Surgical, Medicine
Royal Philips has secured 510(k) approval from the US Food and Drug Administration (FDA) to market its AlluraClarity live image guidance system. The company's AlluraClarity system, equipped with ClarityIQ technology, offers quality ...
Tags: Philips, FDA Approval, X-ray System
Oxford Optronix has launched its third generation OxyLite Pro and OxyFlo Pro systems for tissue oxygenation and blood flow monitoring. Using the fibre-optic micro-sensors, OxyLite and OxyFlo systems provide real-time measurements of ...
MicroPort Medical, a subsidiary of MicroPort Scientific, has signed a definitive agreement with Wright Medical Group, a US-based orthopaedic company, to acquire Wright's OrthoRecon business for $290m in cash. The transaction is subject to ...
Tags: Microport Medical, Medicine
Surgical and therapeutic medical device company Vycor Medical has been issued US patent for its ViewSite Brain Access System. VBAS is a suite of cylindrical disposable devices which provide neurosurgeons a stable, minimally invasive ...
Tags: Vycor Medical, US Patent
US-based spine technology company Spinal Elements have licensed a portfolio of patents necessary for accessing the lumbar spine from a lateral approach and placing implants from that approach. The lateral approach to the spine offer ...