The FDA is warning about the Raindrop corneal inlay developed by now-fefunct ReVision Optics after 75% of patients in a post-approval surveillance study developed corneal hazing. Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the […]
Medtronic wins FDA nod for SynchroMedII myPTM drug therapy manager
Medtronic (NYSE:MDT) said today that the FDA approved its new SynchroMedII myPTM personal therapy manager intended for use in treating patients with chronic pain. The newly cleared device works with the company’s SynchroMedII intrathecal drug delivery system and is designed to handle delivering on-demand boluses within therapeutic limits set by physicians, the Fridley, Minn.-based company said. […]
Monteris wins FDA nod for NeuroBlate Optic laser probe
Monteris Medical said today it won FDA clearance for the NeuroBlate Optic laser probe designed for its minimally invasive magnetic resonance imaging-guided NeuroBlate robotic laser thermotherapy system, which is intended for use in treating brain tumors and epileptic foci. The Plymouth, Minn.-based company said that the newly cleared laser probe replaces previous generation’s metal thermocouple inside […]
FDA approves Medtronic’s Valiant Navion thoracic stent graft
Medtronic (NYSE:MDT) said today that it won FDA approval for its Valiant Navion thoracic stent graft system intended for use in the minimally invasive repair of lesions in the descending thoracic aorta. The Fridley, Minn.-based company said that the stent system is now cleared for use in procedures to repair thoracic aortic aneurysms, blunt thoracic […]
FDA approves Abbott’s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with […]
FDA deals warning letter to Ocular over eye sealant
Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval […]
FDA clears Viseon’s Voyant MIS spinal surgery tech
Early stage, spinal-focused medical device maker Viseon said today it won FDA 510(k) clearance for its minimally-invasive Voyant system intended for accessing, visualizing and illuminating spinal procedures. The Voyant system is composed of a sterile single-use, disposable retractor device featuring integrated visualization technology and a reusable controller for manipulation of the surgical site image. The […]
Novocure wins CMS review of Optune glioblastoma Tx
NovoCure (NSDQ:NVCR) said today that the durable medical equipment Medicare Administrative Contractors accepted a new local coverage determination reconsideration request for the treatment of newly diagnosed glioblastoma with its Optune system. The St. Helier, Jersey-based company said it plans to “take steps to publish a final LCD for newly diagnosed GBM,” and per the Centers for […]
FDA approves five-year hormonal contraceptive
Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]
3 ways HHS can help medtech innovators
The U.S. Department of Health and Human Services (HHS) is doing everything from sharing more data to cultivating entrepreneurial talent and engaging in partnerships in order to support medical device innovators, the department’s CTO Ed Simcox told than 100 industry insiders in the Twin Cities today. A major goal at HHS is to build an innovation-focused […]
Kala seeks FDA nod for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease. The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala […]
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