The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
FDA approves Philips’ low-dose Stellarex balloons
Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg arteries. The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to […]
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee Act […]
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 […]
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 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 […]
ICU Medical recalls infusion sets
ICU Medical (NSDQ:ICUI) said today that it is recalling certain lots of its Plum and Sapphire microbore infusion sets with inline filters due to the potential for small amounts of fluid to leak from the filters’ air vents. San Clemente, Calif.-based ICU Medical said it is not aware of adverse events related to the problem, […]
Teleflex says infant breathing device it distributes is recalled
Teleflex (NYSE:TFX) today announced a recall of a device used to help newborns with infant respiratory distress syndrome to breathe. Teleflex is one of the U.S. distributors of the device, the Babi.Plus 12.5 cm H2O pressure relief manifold, manufactured by GaleMed. The FDA has designated the recall as Class I. The recall began June 14 […]
Medtronic bids for FDA approval of OAB/FI neuromodulation device
Medtronic (NYSE:MDT) said today that it filed a pre-market approval supplement with the FDA for its InterStim Micro neurostimulator and its InterStim SureScan MRI leads. The InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to send electrical impulses to sacral nerves and normalize connections between the brain, bladder and bowel for treating patients with […]
A ‘rolling effect’ on medtech sterilization plants?
The types of regulatory hurdles that contributed to the permanent closure this week of the Sterigenics medtech sterilization plant in Willowbrook, Ill., have created a “rolling effect” on ethylene oxide (EO) plants around the country, according to an industry official. The state of Illinois temporarily shut down the Willowbrook plant in February over emissions of EO, a […]
URGENT/11 cybersecurity vulnerabilities could affect medtech
This article has been updated with information from BD. Cybersecurity researchers have identified 11 vulnerabilities that could allow anyone to remotely take control of an imaging system, an infusion pump or an anesthesia machine, according to the FDA. More types of devices may be affected as well. The vulnerabilities, called URGENT/11, allow attacks to occur […]
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