iCad (NSDQ:ICAD) has won the CE Mark for its advanced artificial intelligence technology and workflow solution, ProFound AI for 2D mammography. The Nashua, N.H.-based cancer detection and radiation therapy devices maker developed the technology to boost breast cancer detection by identifying soft-tissue densities and calcifications. ProFound AI for 2D mammography is the latest addition to […]
Advent Access wins CE Mark for dialysis device
Singapore-based vascular access device company Advent Access said it has received the CE Mark for its av-Guardian technology designed to create vascular access for dialysis patients. The device-guided needling platform features the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins. The technology […]
Meril Life Sciences’ MyVal TAVR wins CE Mark
Indian medtech maker Meril Life Sciences said it has won the CE Mark for its MyVal-THV system, a transcatheter aortic valve replacement (TAVR) developed exclusively in India. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
Acandis stent retriever wins CE Mark
Device maker Acandis said it has received the CE Mark for its Aperio hybrid stent retriever. Aperio is designed for efficient clot retention and fast arterial flow restoration in ischemic stroke patients with a large intracranial blood clot, according to the Pforzheim, Germany-based company. “Our engineers combined the proven, reliable and effective hybrid cell design […]
Vertos Medical’s spinal stenosis treatment wins CE mark
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 […]
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