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 — 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 — 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 20, 2012 — Hospitals, medical facilities, doctors and long-term care facilities this fall are stocking shelves and purchasing items from their wish list and budgets before a new tax on most medical products goes into effect in 2013.

September 19, 2012 — Heart catheter procedures guided by magnetic resonance imaging (MRI) are as safe as X-ray angiography-guided procedures and take no more time, according to a pilot study conducted at the National Institutes of Health (NIH). The results of the study indicate that real-time MRI-guided catheterization could be a radiation-free alternative to certain X-ray-guided procedures.

September 19, 2012 — This past week, surgeons and cardiologists at Sentara Heart Hospital were the first in the world to begin performing surgeries in the Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study (Staged DEEP) feasibility trial.

First-year medical students at Mount Sinai School of Medicine will be the first in New York to be introduced to a digital-age ultrasound device that can visualize inside the body, and fit directly into the pockets of their brand new white coats.

September 18, 2012 — Neovasc Inc. announced that acute results from preclinical studies of its Tiara valve for the transcatheter treatment of mitral regurgitation were published in the Journal of the American College of Cardiology (JACC). The study reports that the initial experience with the Tiara transcatheter mitral valve was encouraging, and that implantation of Tiara valves was feasible, relatively straightforward and resulted in a securely-implanted, well-functioning device that maintained good hemodynamics in the test animals. The study, which will be published in the Oct. 9, 2012, edition of JACC, is currently available online.