Specialty Pharma Journal Specialty, Precision & Technology
MARLBOROUGH, Mass., Nov. 20, 2018 /PRNewswire/ — Boston Scientific (NYSE: BSX) today announced it has reached an agreement on the terms of a recommended offer to acquire BTG plc. (LSE: BTG), a company headquartered in the United Kingdom, which develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well …
Tag Archives: Medical Devices
November, 2018
August, 2016
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5 August
FDA Issues Draft Updated Recommendations on Submitting a New 510(k) for Device Modifications
The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices. “These draft recommendations are intended to help manufacturers …
March, 2015
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9 March
FDA Clears First-of-Kind Device to Treat Patients with Dialysis-Related Amyloidosis
US health regulators cleared use of a first-of-its-kind device to treat dialysis-related amyloidosis (DRA). The US Food and Drug Administration (FDA) authorized use of Lixelle Beta 2-microglobulin Apheresis Column under its pathway for medical devices that treat rare conditions. The device is used to treat DRA, a chronic, progressive condition …
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4 March
Mayo and Gentag Partner to Develop Wearable Biosensors for Treating Diabetes
Mayo Clinic and Gentag, Inc. have teamed up to develop next-generation, wearable biosensors designed to fight diabetes and obesity. The companies have reached a joint intellectual property (IP) agreement to develop the first-of-its-kind, wearable patch sensors, which are wireless and the size of a small bandage. The sensors are designed …