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. […]
Ireland faces device shortage in wake of no-deal Brexit
A “significant” number of essential medical devices made by small- and medium-sized medtech companies will go in short supply in Ireland in the event of a no-deal Brexit, according to a report in the Irish Times. An Irish health service analysis of the possible effects of a hard Brexit revealed the number of devices that […]
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 […]
Ga. wants more emissions testing at Sterigenics’ Atlanta sterilization plant
Georgia state officials want more test results from Sterigenics before they will allow the company to reopen its medtech sterilization plant in Atlanta. In a letter dated Wednesday, the state Environmental Protection Division (EPD) told Sterigenics to test new emissions-control equipment that the company installed after voluntarily closing the plant Aug. 26, and to report […]
Navigating the constantly choppy waters of medical device regulation
Regulations at the FDA and in the European Union are in constant flux, and that’s not even mentioning Brexit. Here’s how one regulatory expert keeps ahead of the changes. The regulatory space for medical devices is always evolving. Manufacturers have to keep up not only with FDA regulations, but other countries’ rules not to […]
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 […]
LivaNova recalls VNS generators
LivaNova (NSDQ:LIVN) is recalling some of its Model 1000 SenTiva vagus nerve stimulation therapy (VNS) generators, which may reset themselves during therapy. A component supplied by an outside company produces an error that causes the generator to reset and fail to deliver the intended VNS therapy, according to London-based LivaNova. Resets may occur during routine […]
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 […]
HHS proposes regulatory changes to promote value-based payment arrangements
UPDATED Oct. 9, 2019, with comments from press briefing in Minneapolis. The U.S. Department of Health and Human Services today proposed what it’s describing as a modernization of the physician self-referral law in order to promote value-based healthcare. The proposed regulatory changes, which are heading into a 75-day public comment period, say the physician self-referral […]
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 […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
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