Medtronic wins FDA expanded approval for Valiant thoracic stent graft system

From Medical Design & Outsourcing

• Cognition to tout compliance and commercialization at DeviceTalks Boston
  Cognition Corporation, headquartered in Lexington, Mass., has been offering solutions for medical device, pharmaceutical, and combination products compliance and commercialization for more than 10 years. The Cockpit Platform provides the framework for an extensive set of compliance templates. These templates, which include Risk Management and Design Controls, along with professional services, give companies a jump-start […]
• How Abbott is making good on investor promises
  Abbott (NYSE: ABT) has won FDA approval of MR-compatible ICDs – an indication that it could be making good executing on key priorities it inherited when it acquired St. Jude Medical for $25 billion early this year. The news today “lends incremental credibility to our thesis that ABT can and will have a positive impact on STJ […]
• Medtech stories we missed this week: Sept. 22, 2017
  From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, […]
• This Dräger newborn incubator focuses on ‘intact survival’
  The latest in incubator technology from Dräger focuses on long-term health and quality of life, as well as survival. One device paying particular attention to these trends is the Babyleo TN500 IncuWarmer beds from Dräger. Florida Hospital announced it’s the first in the United States to implement the Babyleo beds. The beds are being used in […]
• DeviceTalks Boston: Here’s what you need to know
  DeviceTalks Boston on Oct 2. will give attendees the chance to see some of the best minds in medtech live. There will be learning and networking opportunities galore. Read on and meet some of the top medical device leaders and experts who will be speaking – and discover other highlights from the upcoming show.   Next>> (See […]
• 5 DeviceTalks Boston exhibitors you should know
  DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. The event is hosted by Medical Design & Outsourcing’s sister site MassDevice. Those who attend the event can expect to network with other medtech enthusiasts, attend in-depth interviews with leaders in the industry and […]
• This pen can diagnose cancer in tissue in seconds
  Scientists and engineers in Texas have created a pen-like device that can accurately recognize cancer in tissues during surgery. A team at the University of Texas at Austin has invented a tool used during surgeries that can give results in about 10 seconds, which is 150 times faster than current technology, according to the researchers. […]
• Cyient showcasing contract manufacturing and engineering at DeviceTalks Boston
  Cyient provides value for medtech companies with comprehensive contract engineering and manufacturing solutions that improve productivity, resource capacity, and supply chain efficiency. The company focuses on affordability across the product lifecycle supports cost management and quality. Cyient is experienced in multiple industries with a focus on diagnostic imaging, in-vitro diagnostics and cardiology. Featured services: Value engineering, […]
• FDA clarifies if microneedling should be classified as a medical device
  By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
• The startup pivot: How to rethink your medical device company
  In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical. Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of […]
• South Korean regulators change new medical device regulations
  By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]