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 […]
Presbia plunges on one-year delay for Flexivue Microlens approval
Presbia (NSDQ:LENS) last week delayed the timeline for FDA approval of its Flexivue Microlens for treating far-sightedness after the federal safety watchdog said it wanted another year’s worth of data on the device. Irvine, Calif.-based Presbia submitted its final pre-market approval module to the FDA during the second quarter, including 24-month data for the Flexivue device, saying […]
Tandem wins approval for insulin pump in Canada
Tandem Diabetes Care (NSDQ:TNDM) won a medical device license from Health Canada last week for its t:slim X2 insulin pump. The device integrates directly with Dexcom‘s (NSDQ:DXCM) G5 continuous glucose monitor and is the only system of its kind approved in Canada, according to the San Diego, Calif.-based company. Get the full story at our sister site, […]
FDA clears Transseptal Solutions’ TP Crosser transseptal access device
Medtech developer Transseptal Solutions said yesterday it won FDA 510(k) clearance for its TSP Crosser transseptal access system. The Israel-based company said that the TSP Crosser is an advanced transseptal puncture system which features a built-in steering mechanism and is designed for use in accessing the left atrium. The system is intended for use during […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
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