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March 14, 2013News for medical technology professionals

  Top Story 
  • RTI wins FDA nod for device used in soft tissue repair
    The FDA has given RTI Biologics 510(k) clearance to market its porcine dermis implantable device, which is intended for use in hernia repair and other soft tissue fixation procedures. The device, slated for U.S. distribution later this year, serves as a scaffold that can be used for neovascularization or that can be reincorporated with the patient's own tissue. RTT News (3/13) LinkedInFacebookTwitterEmail this Story
Stentys Pulls Back Curtain on APPOSITION III One-Year Results
Stentys (Princeton, N.J.), a company commercializing in Europe a Self-Apposing Stent to treat acute myocardial infarction (AMI), unveiled one-year results of the APPOSITION III clinical trial in 1,000 patients post treatment of a severe heart attack at the American College of Cardiology's Scientific Session & Expo. Find out the details.

  Business & Market Trends 
  International Developments 
  • EU approves Nanosphere's gram-negative blood assay
    Nanosphere has earned CE mark approval to market its Gram-Negative Blood Culture, or BC-GN, test in Europe. The device, which runs on the company's automated Verigene System, allows for the rapid diagnosis of bacteria that can trigger bloodstream infections. RTT News (3/13) LinkedInFacebookTwitterEmail this Story
  Industry Insight 

  Science & Health 
  • Firm gains about $13M for glaucoma ultrasound device trial
    Investors pumped almost $13 million into EyeTechCare, which the company intends to use to support a clinical study of its EyeOP1 system and help it pursue FDA approval for the product. The device already has CE Mark approval in Europe and is designed to treat patients with glaucoma using high-intensity focused ultrasound. (Boston) (3/13) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 

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  Government & Regulatory 
  • FDA regulation of mHealth apps to be subject of hearings
    The House Energy and Commerce Committee will hold hearings next week to discuss how mobile health applications should be regulated by the FDA. Earlier this month, panel members sent a letter to the FDA citing concerns that developers could be subject to a tax under the Affordable Care Act if the agency classifies such apps as medical devices. The Washington Post/Post Tech blog (3/12) LinkedInFacebookTwitterEmail this Story
  • Optos gets FDA OK to add microperimetry to OCT SLO device
    The FDA has cleared Optos to incorporate microperimetry testing into its OCT SLO system. The 510(k) clearance makes the technology the only commercially available device that provides functional microperimetry evaluation and structural optical coherence tomography, the company said in a release. Healio (3/13) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Design and Analysis Challenges for Pediatrics and Rare Diseases
    Monday, April 22
    Sheraton Crystal City, Arlington, Va.
    This meeting gives viewpoints from various stakeholders -- physicians, regulators, ethicists, payers, patients, statisticians and  clinical researchers -- and shows you how to provide medical devices and diagnostics to pediatric and rare disease populations that are supported by data from appropriately designed and analyzed clinical trials. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • 6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop
    Tuesday, April 23 – Wednesday, April 24
    Sheraton Crystal City, Arlington, Va.
    This annual conference, co-sponsored by the FDA and AdvaMed, brings together leading authorities from the FDA, industry and academia to address statistical topics such as CDISC, data standard, FDA guidances, sample size estimation and re-estimation, and more. On Day 2, the conference will be split into focus areas: therapeutic devices and IVD products addressing guidance documents; a report from the equivocal results sub-group; combination products; and technology-related issues. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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