The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective Oct. 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA:


September 24, 2012 — Surgically inserted cardiac devices play an important role in treating certain heart problems. In fact, an estimated 400,000 devices, including pacemakers and cardioverter defibrillators, are implanted each year in the United States. Still, selecting patients in whom these devices will provide the most benefit can be challenging.

September 24, 2012 — Bio DG announced that its patent for a novel metal system, to use as biodegradable material in developing implantable medical devices, was granted by the U.S. Patent Office on Aug. 21, 2012. Bio DG's biodegradable alloys are primarily metallic and provide high strength when first implanted, then gradually erode in a predictable and biocompatible manner.

September 21, 2012 — Endologix Inc. announced this month it received CE mark for the current version of the Nellix EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms (AAA).

September 21, 2012 — Following the success of Biotronik’s Pulsar-18 0.018-inch, 4 French platform self-expanding stent system, the company has introduced its Pulsar stent technology in a 0.035-inch, 6 French platform.

September 21, 2012 — Cardionovum GmbH announced that the results of a preclinical study and a first-in-man clinical study of its Primus drug-coated balloon (DCB) will be published in the October issue of Minerva Cardioangiologica, the journal of the Italian Society of Angiology and Vascular Pathology and of the Italian Society of Vascular Diagnostics.

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