Intuitive Surgical (NSDQ:ISRG) today reported better-than-expected earnings and revenue for its second quarter amid 24% year-over-year growth in shipments of da Vinci surgical systems. The dominant robot-assisted surgery company reported profits of $318.3 million, or $2.67 per share, on sales of $1.10 billion for the three months ended June 30, 2019, for a bottom-line gain of […]
Abbott wins FDA approval for its fourth-generation MitraClip
Abbott (NYSE:ABT) announced today that U.S. FDA has approved the MitraClip G4, the most advanced version yet of the company’s transcatheter heart valve repair device to treat mitral regurgitation. Abbott expanded the number of clip sizes to four for the MitraClip G4, including clips with a wider grasping area, in order to expand the treatment options […]
GE Healthcare recall involves tens of thousands of infant warmers
GE Healthcare (NYSE:GE) has alerted health providers to inspect the bedside panels and latch areas of all Giraffe and Panda i-Res infant warmers, after 338 complaints of panels malfunctioning. In two cases, infants fell from warmers and cracked their skulls, but there have been no reports of deaths, according to the U.S. FDA. The FDA […]
Keystone Heart inks distribution agreement with Vasorum
Keystone Heart has started distributing Ireland-based Vasorum’s Celt ACD vascular closure device in the U.S. and Europe, effective this month. Approved by FDA in 2016, the Celt ACT is a biocompatible implant meant to close femoral artery punctures taking place after catheterization. Health providers have implanted the CeltACT in more than 40,000 patients to date. […]
Sonendo raises another $17m for acoustic-based root canal treatment tech
Sonendo has brought in $17 million — its latest multimillion-dollar money raise as it expands marketing of its GentleWave system that uses acoustic energies to better clear out a tooth’s root canal system. The roughly $17 million matches the full amount that Laguna Hills, Calif.–based Sonendo was seeking to raise, according to a Form D […]
Activ Surgical raises $13m
Activ Surgical has raised nearly $13 million as the company continues development of its Smart Tissue Autonomous Robot (STAR). The Boston-based company has been seeking nearly $19 million in the money-raise, according to a Form D filed with the U.S. Securities and Exchange Commission on July 1. Founded in 2017, Activ’s initial technology is STAR. […]
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 […]
Tekni-Plex buys three healthcare packaging plants
Tekni-Plex recently announced that it has completed its purchase of three manufacturing facilities from Amcor’s Flexible Packaging business unit. The facilities are in Madison and Milwaukee, Wis., and Ashland, Mass., and provide sterilizable medical device packaging substrates including coated and uncoated Tyvek, heat-seal and cold-seal coated paper and films, medical grade laminates and die-cut lids and labels. Get the full […]
50 medtech startups you need to know
Medical device industry accelerator MedTech Innovator today announced about 50 medtech startups participating in its annual four-month program. Half are early-stage companies participating in MedTech Innovator’s Accelerator and Showcase program, and the other half are mid-stage companies in the organization’s Showcase program. The list of companies is a who’s who of people around the world […]
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. […]
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 […]
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