| March 14, 2013 | News for medical technology professionals |
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- 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
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| 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. |
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| Business & Market Trends | | |
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| International Developments | | |
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- 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)
| Industry Insight | | |
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| Science & Health | | |
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- 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. MassDevice.com (Boston)
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| Government & Regulatory | | |
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- 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)
- 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.
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| Position Title | Company Name | Location |
| Sales Area Manager/Sales Rep of Neurovascular Intervention Products | Asahi Intecc USA, Inc. | Any location in US, CA |
| Project Manager, Regulatory Affairs - Transfusion Medicine | Johnson & Johnson | Raritan, NJ |
| Associate Counsel | ACell, Inc. | Columbia, MD |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Director, Health Care Compliance | RTI Biologics | Alachua, FL |
| Accreditation Manager | American Association of Tissue Banks | McLean, VA |
| REGULATORY AFFAIRS SPECIALIST | Masimo Corporation | Irvine, CA |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
| DIR OPERATIONS, Milpitas Site - 130000007R | Abbott | San Jose, CA |
| Biostatistician - Post Market Surveillance | Johnson & Johnson | Raynham, MA |
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| Click here to view more job listings. |
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