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Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract. The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release. “We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a di...
Source: Mass Device - May 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Cook Medical Source Type: news

4 Trends Advancing Medtech
For the past 20 years, the Medical Design Excellence Awards have celebrated medical products that improve the quality and accessibility of healthcare. Our finalists this year carry on this tradition, while also keeping in step with today’s high-tech digital and consumer trends. With the help of our esteemed jurors, we have identified four key trends in this year’s group of finalists: risk reduction; faster, more-efficient healthcare delivery; the influence of the Internet of Things; and the consumerization of healthcare. We’ve been tracking a few of these trends in past awards programs, so they’re not necessarily n...
Source: MDDI - April 27, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M East (New York) Design Source Type: news

Baxter acquires surgical products
Baxter International Inc., a global medical products company, said Monday that it will acquire two hemostat and sealant products from Mallinckrodt.It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction." Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons ' varying needs, " said Wil B...
Source: Medical Hemostat - January 9, 2018 Category: Medical Devices Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs