Micro Medical Solutions said yesterday that it won a nod from the FDA to run a clinical trial of its MicroStent below-the-knee device for treating peripheral artery disease. The Wilmington, Mass.-based company’s MicroStent won CE Mark approval in the European Union in February 2017. A small feasibility study completed last fall met all primary endpoints […]
FDA formally ends secret alternative reporting of adverse events
The FDA today said it ended a program that allowed medical device makers to report adverse events to the agency without alerting the public, fulfilling a pledge made after the secret database was brought to light earlier this year. The federal safety watchdog’s Alternative Summary Reporting repository contains at least 1.1 million adverse event reports […]
Two deaths reported in recall of 6 million Teleflex endotracheal tubes
Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA. Each of the more than 6 million recalled tracheal tubes includes an appropriately sized […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. Get the full story on our […]
Cook Medical recalls peripheral catheters on burst balloon risk
Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure. In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat […]
Axonics wins FDA nod for MR-safe neurostim device in trial
Axonics Modulation Technologies (NSDQ:AXNX) said today that the FDA approved the use of full-body MRI for clinical trial participants implanted with the company’s sacral neuromodulation device. The Irvine, Calif.-based company submitted a supplement to the FDA regarding the use of full-body MRIs in its Artisan-SNM 129-patient pivotal trial. The FDA, which is evaluating Axonics’ device via […]
Artificial intelligence and medical devices: Why you need to care
Artificial intelligence presents a whole host of regulatory challenges when it comes to medical devices. Regulatory consultant Mike Drues says he has had clients forced to dumb down their AI technology, with U.S. FDA requiring they lock the algorithm. Drues sees locking the machine learning algorithm is a Band-Aid solution — not a longterm fix. […]
Apollo Endosurgery updates labeling on intragastric balloon
Apollo Endosurgery (NSDQ:APEN) said today that the FDA has approved its proposed labeling updates for the Orbera intragastric liquid-filled balloon system, which is used to treat obesity. The goal of the labeling updates is to improve patient safety and they will take effect immediately, according to the Austin, Texas-based company. The Orbera system and Reshape […]
Materialise wins FDA clearance for 3D modeling software for cardio procedures
Materialise said today that FDA has provided 510(k) clearance for its Mimics Enlight — a cardiovascular procedure planning software creating accurate 3D printed heart models. The Belgian 3D printing software and services company, which has its U.S. offices in Plymouth, Minn., plans the first release of the software to focus on planning for complex transcatheter […]
Nuvectra seeks another FDA nod for spinal cord stimulation system
Nuvectra said yesterday that it filed for expanded FDA approval of its Algovita spinal cord stimulation device. The Plano, Texas-based company asked the federal safety watchdog for full-body MR-conditional approval for the Algovita SCS. The device first received FDA premarket approval in 2015. “We believe full-body MR conditional approval in the U.S., in addition to Algovita’s […]
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