At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.
March 4, 2019 – Several members of the iuvo BioScience toxicology team co-authored a paper entitled Suitability of Long-Term Frozen Rat Blood Samples for the Interrogation of Pig-a Gene Mutation by Flow Cytometry. The paper was co-authored by Dr. Mary Richardson, Matt Barragato, Brett Schneider and John Prattico of iuvo, along with Avlasevich, et al, […]
The International Standards Organisation (ISO) recently published a new technical standard, ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents. The TTC is a recognized tool for evaluating the biological risks of impurities when they are present at low levels and […]
On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. In the Supplementary Information Sheet (SIS), it was noted that the FDA does not recognize Table A.1 in Annex A of the standard as it is in […]
January 28, 2019 – iuvo Chief Scientific Officer and cofounder Dr. Mary Richardson presented at the Sixth Annual Girl Scouts “Women who ROC” seminar series on Friday, January 25, 2019. The event allows local women leaders the opportunity to talk to the scouts about how to build successful careers. Dr. Richardson spoke about entrepreneurship, small […]
On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its “intended use” rule due to concerns raised by the industry. The FDA issued a Federal Register notice, attached here after the link, explaining that the delay of implementation would be “until further notice” and referenced a number […]
Dr. Mary Richardson, iuvo’s Chief Scientific Officer, was honored Wednesday evening, January 17, 2018 at a reception with the other finalists for the 2018 ATHENA Awards. The ATHENA Award is presented by the Rochester Chamber of Commerce and honors professional women leaders who strive toward the highest levels of personal and professional accomplishments, devote time […]
There’s frequently a flurry of FDA announcement near the end of the year, and this year was no exception. We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers. The summaries below link to some of the more interesting guidance documents recently released. In late December, […]
December 29, 2017 – The iuvo team came together this year to give something back for the holidays. iuvo participated in adopting a family in conjunction with Spiritus Christi church of Greater Rochester to celebrate the holidays. In the weeks leading up to Christmas, iuvo staff members purchased and gathered gifts for the family, plus […]
Hello, and Happy Holidays! Welcome to our first edition of “iuvo InSights”, our newly established monthly newsletter. There are a number of very exciting things happening at iuvo BioScience, and across the industry – and each month this newsletter will provide a sampling of the things we are doing, what we are seeing and how […]
On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices. The document “Technical Considerations for Additive Manufactured Medical Devices – Guidance for Industry and Food and Drug Administration Staff” is meant to outline the agency’s current thinking about devices made via these processes and will be supplemented by […]
