Top Story

• ConvaTec beefs up critical care business with AbViser Medical buy
  AbViser Medical, maker of an intra-abdominal pressure tracking device and other products targeted for use in critical care environments, has been acquired by ConvaTec for undisclosed terms. ConvaTec expects the acquisition, which was finalized on Tuesday, to complement its critical care and continence business. Modern Healthcare (subscription required) (5/2)     

Business & Market Trends

• Gene sequencing device maker pulls in $50.8M in financing
  A private placement of ordinary shares brought Oxford Nanopore Technologies $50.8 million in new funding. Oxford will use the money to create a commercial infrastructure, increase its production capabilities, add to is intellectual property portfolio and support research and development. The firm intends to commercialize two DNA sequencing platforms this year. GenomeWeb Daily News (free registration) (5/3)     

• Mass. surgical image management startup gets $600K boost
  A round of equity financing from three backers has brought in $600,000 for Image Stream Medical. The Littleton, Mass.-based firm was launched in May 1999 with the goal of creating products for the minimally invasive management of surgical images. Mass High Tech (Boston) (5/3)     

• Bioscience incubator slated to open next month in Ariz.
  BioInspire, an incubator that aims to invest in biomedical device startups, is scheduled to launch next month at a 6,800-square-foot facility in Peoria, Ariz. The incubator is a collaborative effort among the Peoria City Council, Plaza Companies and BioAccel, and has an annual city funding estimated at $1.6 million over a three-year period. The Arizona Republic (Phoenix) (5/4)     

Effective Post-Market Clinical Follow-Up Post-market surveillance including clinical follow-up, complaints, and vigilance are vital in ensuring compliance with the EU medical device directives, and are an essential component of a 13485 Quality Management System. Learn more about PMS and Vigilance. Visit the PMS Spotlight

International Developments

• Smith & Nephew targets sevenfold growth in Brazil
  Smith & Nephew CEO Olivier Bohuon said in a recent investors' call that his company aims to grow its orthopedic device business in Brazil sevenfold and potentially generate more than $150 million in revenue there. To that end, the company has added a general manager role to oversee its Brazil operations, with plans to boost its presence in that country even more. MassDevice.com (Boston) (5/4)     

Science & Health

• Study aims to test use of CT, blood assay in lung cancer diagnosis
  A trial being launched at National Jewish Health in Denver will combine the use of a low-dose CT scan and Oncimmune's EarlyCDT-Lung blood assay as a way to improve early-stage lung cancer detection. The four-year trial will involve 1,600 individuals ages 50 to 75 years and who have a history of smoking one pack a day for at least 20 years, among other criteria. HealthImaging.com (5/7)     

Emerging Technologies

• Sanofi announces U.S. launch of iPhone-enabled glucometer
  Sanofi said its iBGStar device used to measure and transmit a patient's blood glucose readings to health care providers wirelessly is available commercially in the U.S. The device is billed as the first blood glucose meter to be approved by the FDA that is accessible on the iPhone or iPod touch. MedGadget.com (5/4)     

• Robotic heart device from Hansen to debut at Boston event
  Hansen Medical plans to unveil its Sensei X Robotic Catheter System at a conference scheduled this week in Boston. The technology uses robot-aided tools to allow doctors to assess heart rhythm disorders without exposing patients to nuclear or X-ray radiation and without the need to use dye to perform other tests. TMCNet.com/Healthcare Robotics (5/4)     

Featured Content

Hot Topics

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

• J&J unit wins FDA nod for laparoscopic surgery device (MassDevice.com (Boston))

• J&J makes first medical device acquisition in China (MassDevice.com (Boston))

• Nephros wins FDA nod for chronic renal failure device (Reuters)

• Cameron Health wins FDA panel vote for cardiac device (Reuters)

• Dutch firm acquires Kensey Nash for $360 Million (Bloomberg)

• Results based on number of times each story was clicked by readers.

Industry Service Providers

• Mindray to launch ultrasound device with advanced features
  The DC-8 ultrasound device from Mindray Medical International is being showcased at a conference this week in San Diego. The system comes with advanced features designed to make it easier to use, enhance patient management and boost user confidence. AuntMinnie.com (free registration) (5/4)     

Government & Regulatory

• Senate panel OKs bill to address pediatric drugs and devices
  A bill aimed at improving the safety of medical devices and drugs for children cleared the Senate Health, Education, Labor and Pensions Committee. The measure, introduced by Sen. Jack Reed, D-R.I., as part of legislation to reauthorize FDA user fees, will go through a full vote in the Senate. BeckersHospitalReview.com (5/4)     

AdvaMed News

• Getting to Market in the EU: Making Sense of the Many EU Requirements for Clinical Data
  Tuesday, May 8
  Webinar, 12:00 p.m. - 1:00 p.m. EST
  With the recent medical device scandals in the EU, the commissioner has publicly requested tighter controls. Clinical evaluations are an area that have come under scrutiny in recent years, resulting in multiple changes in the regulations and standards, and creating additional potential consequences for manufacturers who are selling legacy devices or planning to introduce new models in the EU. Device manufacturers need to know what the new requirements are and how they may affect existing and new product certifications. In this live webinar, participants will have the opportunity to hear from the expert presenter, Dr. Dannhorn, on strategies for meeting the new requirements and have the opportunity to ask questions. Visit MTLI online for more information.     

• Supplier Controls: Regulations and Best Practices Virtual Meeting
  Wednesday, June 6
  Virtual Conference, 10:00 a.m. - 4:00 p.m. EST
  Recent enforcement actions and several product-related tragedies highlight the risks of inadequate vendor selection and oversight, poor communication, misunderstanding of regulations and responsibilities, and a failure to apply the same risk-based approach to supplied components and services that one applies to one's own products and processes. This virtual conference brings together leading authorities from the FDA, industry and critical component suppliers to discuss strategies and best practices for instituting and maintaining a robust and responsible supplier control program. Visit MTLI online for more information.     

Position Title Company Name Location Corporate Compliance Manager Endologix, Inc. Irvine, CA Sr. Clinical Research Associate Endologix, Inc. Irvine, CA Director of Regulatory Systems; Corporate Smith & Nephew, Inc. Andover, MA Director of Regulatory Systems - Corporate Smith & Nephew, Inc. Memphis, TN Director of Internal Audit QA/RA - Corporate Smith & Nephew Inc. Memphis, TN Principal Regulatory Affairs Specialist-Endo-Santa Rosa CA Medtronic Santa Rosa, CA Senior Business Systems Analyst - 001324 Edwards Lifesciences Irvine, CA Staff Engineer - Cardiac Surgery Systems - 001281 Edwards Lifesciences Irvine, CA Regional Sales Director Regenesis Biomedical, Inc. Home based office, CA Manager, Regulatory Affairs - 1 of 2 Johnson & Johnson Fremont, CA R&D Technical Project Manager Endologix, Inc. Irvine, CA Post Market Surveillance Regulatory Specialist W.L. Gore Phoenix, AZ Regulatory Affairs Professional W.L. Gore Flagstaff, AZ Director Global Marketing -- Core Brand Management Covidien New Haven, CT Regulatory Affairs Professional W.L. Gore Flagstaff, AZ Regulatory Affairs Professional W.L. Gore Flagstaff, AZ Sr. Quality Engineer - New Product Development Endologix, Inc. Irvine, CA Regulatory Affairs Professional — Venous/Access W.L. Gore Flagstaff, AZ Vice President – Research, Payment and Health Care Delivery Policy AdvaMed Washington, DC Public Affairs Coordinator AdvaMed Washington, DC Director, Marketing Endologix, Inc. Irvine, CA Senior Program Manager - Critical Care - 001311 Edwards Lifesciences Irvine, CA Project Manager, Supplier Development - Transcatheter Heart Valve - 001303 Edwards Lifesciences Irvine, CA Regulatory Affairs Manager Johnson & Johnson Irwindale, CA

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The word 'listen' contains the same letters as the word 'silent.' " --Alfred Brendel, Austrian pianist