RUSH, NY – September 5, 2019 – Ocuphire Pharma, Inc., a clinical-stage pharmaceutical company and partner of iuvo BioScience’s ophthalmic-focused Oculos Division, announced that it has successfully enrolled 39 glaucoma patients in ORION-1 at 5 U.S. sites from late May to August 2019. Ocuphire has been collaborating closely with Oculos Development Services to achieve these clinical […]
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.
September 3, 2019 – iuvo CEO Ben Burton was interviewed on the Legal Drugs Podcast in the most recent episode (episode 5) which became available September 2. The interview took place at the 2019 Society of Toxicology meeting, and provided an opportunity for Ben to speak with Legal Drugs Podcast host Angela Stoyanovitch on testing […]
You are invited to attend the upcoming Society of Toxicology (SOT)-sponsored webinar hosted by Ocular Toxicity and Medical Device/Combination Product Specialty Sections (OTSS and MDCPSS) of the SOT. The details are provided below. Iuvo’s own Dr. Kathleen Krenzer is the President of the Ocular Toxicology Specialty Section of the Society of Toxicology.
May 10, 2019 – Ten iuvo employees volunteered at an Epilepsy Pralid Individualized Residential Alternative (IRA) home yesterday as part of the Rochester Day of Caring event. This was our first year participating in the event and we were able to spruce up the outdoors for spring by mulching, planting, weeding, and doing some general […]
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 […]
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 […]
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 […]
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 […]