The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation. The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
Ex-NuVasive CEO Lukianov gets in on Fusion Robotics
Former NuVasive (NSDQ:NUVA) CEO Alex Lukianov got in on an unspecified funding round for Fusion Robotics, which is developing a robot-assisted device for spine procedures. Boulder, Colo.-based Fusion Robotics’ device is an integration of the localization technologies of Austrian firm Interventional Systems and the navigation technology developed by Practical Navigation, also based in Boulder. Lukianov, who […]
Brazil ANVISA modifies custom-made medical device regulations
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Boston Scientific opens Irish facility
Boston Scientific (NYSE:BSX) yesterday announced that it officially opened its new Galway, Ireland facility. The Marlborough, Mass.-based company’s €60 million expansion will house 250 employees in the three-story building, according to the Galway Daily newspaper. Get the full story on our sister site, Medical Design & Outsourcing.
Transplant Biomedicals touts kidney transport device study results
Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results. The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed […]
LRQA to withdraw European Notified Body medical device and IVD manufacturers services
By Ronald Boumans, Emergo Group UK-based Notified Body Lloyd’s Register (LRQA) plans to withdraw European Notified Body (NB) services for medical device and IVD manufacturers later in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Heraeus can pursue trade secret suit against Zimmer Biomet supplier
A federal appeals court has resuscitated part of a 2014 Heraeus Medical GmbH lawsuit that accuses Esschem, a chemical supplier to Zimmer Biomet (NYSE:ZBH), of stealing Heraeus’ bone cement recipe. The three-judge panel in Philadelphia said on Friday that Heraeus can pursue claims stemming from Esschem’s alleged use of Heraeus’ information within three years before […]
8 medical device industry supplier innovations you need to know
Medical device innovation doesn’t just come from startups or big corporate R&D departments. Contract manufacturers and suppliers are increasingly playing a role, too. [Image by Kristopher Roller on Unsplash] Long gone are the days when medical device industry suppliers simply produced or manufactured according to specifications. Companies are increasingly coming up with their own answers […]
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 […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up to 30 days […]
First patients implanted with Exactech’s non-cemented Truliant knee
Exactech (NSDQ:EXAC) today announced the successful first surgeries involving its Truliant Porous knee implant. Truliant Porous is a non-cemented implant system that Exactech said is designed for reproducibility and efficiency in total knee arthroplasty. Truliant Porous is designed to reduce micromotion and aid potential bony in-growth, according to the company. The system features a unique […]
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