Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Medtronic wins PMA for abdominal aortic aneurysm stent
The Food & Drug Administration (FDA) approved the Endurant AAA Stent Graft System from Medtronic, Inc. (NYSE:MDT) for the minimally invasive treatment of this largely unknown, and often fatal, condition. An estimated 1.2 million people in the United States have an abdominal aortic aneurysm (AAA) – a dangerous bulge or ballooning in their bodies’ main artery that typically causes no symptoms until it ruptures, which can be deadly – and most of them don’t know it. But for those with a known AAA of a certain size, there’s a new medical device for a safe and effective treatment option that doesn’t require major surgery, an extended hospital stay and a long recovery period.
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- MiMedx Receives Additional CE Certification for Its HydroFix Technology
MiMedx Group, Inc. (OTC:MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has received notification of the Class III certification for a European product using the Company’s proprietary HydroFix™ technology.
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- Modified FlexStent Biliary Self Expanding Stent System Receives FDA 510(k) SE Clearance
Flexible Stenting Solutions Inc., a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced today that it has received 510(k) clearance for an improved FlexStent® Biliary Self Expanding Stent Delivery System and an expansion of Biliary stent sizes.
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- Vitrolife: the Food & Drug Administration, FDA, Approves Vitrolife’s Products for Cold Storage of Embryos
Vitrolife (STO:VITR) has received approval from the Food & Drug Administration, FDA, the equivalent of the Swedish Medical Products Agency, for the products RapitVit™ Blast and RapidWarm™ Blast. So-called 510(k) clearance has been obtained for these products, which are used for so-called vitrification, the rapid freezing and thawing of blastocysts (embryos days 5-7 after fertilization). Vitrolife has since before approved products for vitrification of embryos in an earlier stage of the fertilization (embryos day 2-3 after fertilization).
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- Charter Medical Receives FDA 510(k) Clearance for Next Generation CELL FREEZE Cryogenic Stem Cell Storage Containers
Charter Medical, a subsidiary of Lydall, Inc. (NYSE:LDL) announced today that it has received 510(k) clearance on its next generation Cell Freeze® Cryogenic Storage Containers for Hematopoietic Progenitor Cells (HPC’s). The issuance of the clearance by the Food & Drug Administration (FDA) allows Charter Medical to begin marketing the newly designed and expanded product offering for cryogenic storage, preservation, and transfer of HPC’s. This next generation of containers offers a broader size range from 50 mL to 750 mL, redesigned configuration for easier use, and the same unique film as its predecessor product.
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- Spartan Bioscience Announces CE Marking for First Point-of-Care DNA Personalized Medicine Testing System
Spartan Bioscience Inc., a privately held molecular diagnostics company that develops, manufactures, and markets DNA testing systems for on-demand applications, today announced its Spartan RX CYP2C19 received a CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices. The CE Mark certification allows commercial distribution in Europe as well as in all countries recognizing the CE Mark in the Middle East, Africa, Latin America, and Asia-Pacific regions.
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