Sky Medical Technology said yesterday that it received FDA 510(k) clearance for its Geko electrostimulation device for preventing venous thrombosis. The Daresbury, England-based company’s Geko device is designed to stimulate the calf muscles to increase blood flow in the deep veins of the calf, preventing venous thrombosis in non-surgical patients at risk for venous thromboembolism. […]
FDA revokes voluntary malfunction reporting for some medical devices
By Marco Theobald, Registrar Corp. The U.S. Food and Drug Administration (FDA) recently updated the Voluntary Malfunction Summary Reporting (VMSR) program eligibility status of several medical device product codes. Some previously eligible devices are now ineligible for VMSR, meaning manufacturers must now submit standard individual Medical Device Reports (MDRs) for the newly ineligible products. FDA […]
New FDA guidance out for vascular device labels
The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices. One covers labels for intravascular catheters, wires, and delivery systems with lubricious coatings, and the other is for coronary, peripheral and neurovascular guidewires. Intravascular devices with hydrophilic or hydrophobic coatings may offer physicians greater maneuverability within blood vessels, and […]
Think Surgical wins FDA clearance for TSolution One robot-assisted total knee device
Think Surgical said yesterday that it won 510(k) clearance from the FDA for its TSolution One robot-assisted total knee replacement device. The TSolution One system uses Fremont, Calif.-based Think Surgical’s 3D pre-surgical planning workstation and computer-assisted Active robot. It won CE Mark approval in the European Union for total knees in December 2017. “We are […]
FDA grants breakthrough nod for Corvia’s interatrial shunt
Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure. The Tewksbury, Mass.-based company’s interatrial shunt is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s the world’s first transcatheter device indicated […]
iRadimed clears 5-year-old warning letter
iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps. The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
Medtronic recalls 6 French Sherpa NX active guide catheters
Medtronic (NYSE:MDT) said today that it recalled all models of its 6 French Sherpa NX active guide catheters due to a material problem that could result in exposed wires. The Fridley, Minn.-based company said the devices were recalled because of a risk of the outer material of the catheter separating from the device, resulting in detached […]
Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on […]
Medtronic wins FDA breakthrough nod for Valiant stent graft
Medtronic (NYSE:MDT) said today that it won breakthrough device designation from the FDA for its Valiant TAAA stent graft for treating thoracoabdominal aortic aneurysms. The newest Valiant graft is designed for minimally invasive repair of TAAA, a complex condition that causes a bulging of the aorta. The standard of care is open surgery, which is associated […]
FDA OKs PQ Bypass trial of Torus peripheral stent graft
PQ Bypass said today that it won full FDA approval of its investigational device exemption trial for the Torus stent graft for treating peripheral artery disease. The Torus stent graft is designed to treat PAD in the superficial femoral artery by aiding in halting the progression of the disease, rather than solely treat the symptoms, […]
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