October 7, 2014 – Indianapolis, IN. Safis Solutions is announcing more marketing clearances for its clients – Stereotaxis, Inc. (Nasdaq: STXS), headquartered in St. Louis and Biomedix, Inc. located in Bloomington, Indiana that have received recent 510k clearances from the Food and Drug Administration (FDA).
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. It was announced earlier this month that the company received approval for its Vdrive™ Robotic Navigation System with V-Loop™ Variable Loop Catheter Manipulator. This is the second FDA clearance for the Vdrive family of products, the first of which came in July of 2013 and was for the Vdrive with V-Sono™ system. Karen Duros, Stereotaxis Senior Vice President & General Counsel said, “This is another important step for Stereotaxis in bringing our Vdrive products to market in the U.S. We have a great deal of confidence in Safis’ ability to deliver and we are pleased that our regulatory program is in good hands.”
Early in 2014, Safis was hired by Biomedix, Inc. of Bloomington, IN to help with an important regulatory submission. On Friday August 8, 2014 Biomedix received a Special 510(k) clearance from the FDA for its SELEC-3® I.V. Administration Set. Biomedix manufactures IV fluid delivery sets for hospitals and emergency first-responders. After the submission was cleared, Biomedix President Myra Bender said she “felt relieved” and that a “huge weight was lifted.” She went on to say, “We couldn’t have done it without Safis’ team. I can’t tell you how pleased I am that everything worked out. I do feel that I hired the right company. Biomedix is eager to resume distribution of all the unique designs of our SELEC-3® I.V. Administration Sets.”
John Nadelin, Vice President of Regulatory & Compliance at Safis, leads the service delivery teams and expressed, “We have a lot of gratitude for our role with companies like Biomedix and Stereotaxis. When approvals like this happen, we are reminded of how our work plays a crucial role in patients’ lives.”
Safis Solutions is a regulatory and quality compliance consulting firm for life science clients worldwide, and the regulatory submission success rate has been 100%. Services successfully executed by Safis have helped more than 150 clients over the past 12 years, meeting regulatory compliance and GxP quality standards and gaining government agency approvals for medical products, manufacturing systems, clinical and laboratory systems.
Ping Poulsen, President and CEO of Safis Solutions, was very pleased with the high quality performance by Safis’ teams. When congratulated on Safis’ success, she commented “it was not me, it was the team work. I am very fortunate to be surrounded by more successful professionals.”
Safis originated from the Indiana University Emerging Technologies Center (IUETC) and has been certified as WBE by WBENC, MBE by MSDC, both MBE and WBE by the state of Indiana and the city of Indianapolis. For more information, contact Thomas (Tom) Stergar II at 317-777-6203.