Vertos Medical said it has received CE mark approval for its lumbar spinal stenosis (LSS) treatment device kit. Aliso Viejo, Calif.-based Vertos said its Mild device kit enables a minimally invasive procedure to remove the cause of stenosis through a portal the size of a baby aspirin. The procedure requires no stitches, general anesthesia, implants or overnight hospital stays, […]
‘Invisible scalpel’ wins CE Mark for Guided Therapy Systems
Guided Therapy Systems has launched its intense therapeutic ultrasound (ITU) Actisound device in the U.K. and Europe following CE Mark approval. Actisound acts like an invisible scalpel, working beneath the surface of the skin to precisely deliver small thermal ablations to tendons, ligaments, and other soft tissue to stimulate collagen growth and the regeneration of connective […]
ARTMS’ system may ease cost, shortage of valuable radioisotopes
ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons. Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear […]
Integer adds radial introducer for patients with smaller arteries
Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark. RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division. The […]
Why U.S. first may be the new medical device development strategy
Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice […]
Ability Dynamics wins CE Marks for Rush foot prostheses
Ability Dynamics said yesterday that it won CE Mark approval in the European Union for its Rush line of foot prostheses. Tempe, Ariz.-based Ability Dynamics said its Rush Kid ultra-low-profile pediatric foot and the Rush Rover ultra-low-profile adult foot both won marketing approval in Europe. Its Rush HiPro and Rush LoPro devices have already been approved across the […]
LifeBond wins CE Mark, FDA fast track for LifeSeal surgical sealant
LifeBond said today that it won CE Mark approval in the European Union for its LifeSeal surgical sealant for gastrointestinal resection procedures, and got on the fast track with the FDA for the surgical sealant. LifeSeal is designed to minimize staple-line leakage during anastomosis or linear surgical repair of the GI tract, Caesarea, Israel-based LifeBond said. […]
Retina Implant wins CE Mark for next-gen blindness implant
Retina Implant said today that it won CE Mark approval in the European Union for the latest iteration of its subretinal implant for patients blinded by retinitis pigmentosa. The Alpha AMS is the next-generation version of the Alpha IMS, which won CE Mark approval back in July 2013. The Reutlingen, Germany-based company said the new device increases the number […]
St. Jude Medical’s Nanostim leadless pacemaker wins MR-conditional CE Mark
St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union for its Nanostim leadless pacemaker. Little Canada, Minn.-based St. Jude said the approval covers MR-conditional labeling for full-body, 1.5-Tesla scans. “The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology,” chief medical officer […]
Mitralign wins CE Mark for namesake heart repair device
Mitralign said today that it won CE Mark approval in the European Union for its namesake device for treating functional mitral regurgitation. Tewksbury, Mass.-based Mitralign said the approval covers patients with symptomatic FMR. Its device, delivered via catheter, is designed to use anchors to help restore the heart’s mitral valve to its natural shape. The company said […]
Xenios wins CE Mark for I-Cor cardiac assist device
Xenios said yesterday that it won CE Mark approval in the European Union for its I-Cor synchronized cardiac assist device, touting it as the world’s 1st “heartbeat-synchronized” cardiac assist for cardiogenic shock and high-risk interventions. Heilbronn, Germany-based Xenios, which claimed in September to have drummed up an 8-figure funding round, said the I-Cor system is designed to provide […]
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