Exhaustive Extractions

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.


iuvo Chili Cook-off to Support United Way a Gastronomical Success

Wednesday, April 17, 2019 – The air was tense as the inaugural iuvo Chili Cook-off to Support the United Way got under way in the iuvo Canteen at high noon-ish on Wednesday. The contestants had been preparing for, well, at least 24 hours, for this challenge. The discerning judges had inscrutable facades as they tasted each […]

Join us for our Webinar on Biocompatibility and the EU MDR

iuvo will be teaming up with R&Q for a webinar on Biocompatibility: EU MDR and the Changing Regulatory Landscape.  The webinar is March 26, 2019, from 1-2pm ET. The slides, webinar recording, and Q&A will be made available to registrants after the webinar. The session will dive into the increased specificity of the EU MDR from […]

iuvo Workshop at the University of Rochester to Introduce ISO-10993 to Engineering Students

On Friday, March 8, 2019, Dr. Mary Richardson and Dr. Kathleen Krenzer from iuvo’s toxicology department lectured and conducted a workshop on ISO-10993 Biocompatibility testing at the University of Rochester. The workshop was conducted for Biomedical engineering students taking a graduate level course on medical devices.  The primary goal was to help the students understand […]

iuvo Staff Co-authors Paper on Pig-a Gene Mutation by Flow Cytometry

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, […]

ISO Publishes New Technical Standard: ISO/TS 21726:2019 Biological Evaluation of Medical Devices

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 […]

FDA Lists ISO 10993-1:2018 as a Recognized Consensus Standard

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 […]

iuvo CSO Mary Richardson Teaches Scouts About Entrepreneurship

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 […]

FDA Delays Implementation of Changes to “Intended Use”

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 Honored at ATHENA Awards Reception

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 […]

Recent FDA Announcements – Accessories and Least Burdensome Provisions

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, […]