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 […]
Ivenix wins 510(k) clearance for infusion system
Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. Get the full story at our sister site, Drug Delivery Business News.
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 […]
Motus GI lands FDA clearance for next-gen colon prep system
Motus GI (NSDQ:MOTS) today announced it has received FDA 510(k) clearance for the second-generation of its Pure-Vu colonoscopy device. Fort Lauderdale, Fla.-based Motus designed the original Pure-Vu device to attach to standard and slim colonoscopes to deliver a mixture of water and air to remove debris when patients haven’t completed their bowel prep. Pure-Vu GEN2 […]
Diabetes patients could soon replace fingersticks with Senseonics implantable CGM
Senseonics (NYSE:SENS) recently announced that the U.S. FDA has approved using the Eversense implantable continuous glucose monitoring (CGM) system as a replacement for fingersticks. Officials at the Germantown, Md.–based medical device company described the FDA approval for the non-adjunctive indication (dosing claim) as a major milestone. The company will make a new app available in coming months […]
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