Istar Medical SA, which is focused on minimally invasive ophthalmic implants for the treatment of glaucoma patients, revealed positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, Miniject.
Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.
Boston Scientific Corp. reported that it has initiated the nationwide U.S. launch of Spaceoar Vue Hydrogel, a radiopaque version of Spaceoar Hydrogel that enables the use of computerized tomography scans instead of requiring magnetic resonance imaging (MRI) for patients undergoing radiation for prostate cancer.
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Medtronic plc has reported the launch of the Inpen integrated with real-time Guardian Connect continuous glucose monitoring (CGM) data. Inpen is the first U.S. FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI). With this integrated system, users will have real-time glucose readings alongside insulin dose information, giving them what they need to manage their diabetes in one view.
Novocure Ltd. has scored another win, this time gaining the CE mark for the NovoTTF-100L system. As a result, Novocure plans to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM).
Abbott Laboratories has seen the launch of the IonicRF Generator, which delivers a nonsurgical, minimally invasive treatment for the management of pain in the nervous system. The generator is a radiofrequency (RF) ablation device that uses heat to target specific nerves and block pain signals from reaching the brain. The launch of Abbott's IonicRF Generator looks to help the estimated 50 million people in the U.S. currently living with chronic pain.
The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.
