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 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 the scope and requirements of ISO-10993 testing, the documentation involved, and how to build a strategy so they could apply these concepts to their medical device prototype projects.

With Greg T. Gdowski, PhD, Executive Director, Associate Professor, Department of Biomedical Engineering

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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.

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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. 

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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.

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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.

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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.

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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 to their community, and forge paths of leadership for other women.

The reception was hosted at Constellation Brands in Victor, New York, and the winner will be announced on January 25, 2018 at a dinner at the Joseph A. Floreano Rochester Riverside Convention Center.

Good luck, Mary!  We're all pulling for you!

Athena Reception Cropped

 

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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.

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iuvo Gives Back for the Holidays

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.

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iuvo InSights Newsletter 2017-12 - Happy Holidays!

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 we can use these insights to help you…our Customer.

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FDA Issues Guidance Document on 3D Printed Devices

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 a webinar in January.  More information on the webinar is available here.  

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FDA Issues New Guidance Documents, Notable Changes to Pre-Submission Process

The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing. 

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iuvo Co-Authors Paper on Socially Housing New Zealand White Rabbits

October 21, 2017 - Members of the iuvo toxicology team co-authored a paper in the October 2017 issue of Comparative Medicine, the international journal of the American Association for Laboratory Animal Science.

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Genetox: Mutational Hazard Identification: Present to Future

As I begin to isolate single bacterial colonies for mutagenicity testing, I couldn’t help but wonder why the bacterial reverse mutation assay has evaded alternate and new technologies for detecting xenobiotic-induced mutation. Of course there is substantial literature and historical data on the salmonella and e. coli strains in wide use today, and there are internationally recognized testing strategies that have been harmonized throughout the past several decades. However, do the highly mutated and compromised bacterial test systems provide any insight into key events along the pathway to mutation? In this day and age, is this the only option to understand the potential for direct DNA reactivity?

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FDA Updates Guidance on Exempt Class II Devices

On July 11, 2017, the US FDA published a final list of Class II devices exempt from 510(k) Premarket Notification Requirements (82 FR 31976).  As mentioned previously here, in an effort to comply with the 21st Century Cures Act of 2016, the Agency originally issued a notice on March 14, 2017 in the Federal Register proposing to exempt a list of Class II devices from the 510(k) premarket notification requirements, with certain limitation (82 FR 13609).  

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FDA Opens Comments on Proposed Laboratory Accreditation Program

The FDA took the first step on the long road of launching a proposed new laboratory accreditation program this month - the Accreditation Scheme for Conformity Assessment (ASCA).

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Beer and Blog: Interview with iuvo CEO Ben Burton

 

iuvo's CEO Ben Burton was the feature interview on Launch Team Inc's Beer & Blog Feature today, in an interview with Michele Nichols, Launch Team's President.  The Beer & Blog format includes an interview combined with a beer tasting.

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EU Parliament Votes to Enact MDR and IVDR

In early April the EU Parliament voted to enact the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The regulations are due to be published in the Official Journal of the European Union in May 2017. Following publication, there will be a three year transition period for the MDR and a five year transition period for the IVDR. These regulations will therefore not be fully enacted until approximately June 2020 and June 2022, respectively.

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FDA Releases 71 Device Product Codes Exempt from All Premarket Notification Requirements

 

On April 13, 2017, as part of the US FDA’s continued efforts to comply with the 21st Century Cures Act of 2016, the Agency published a list of 71 low-risk Class I medical device product codes that are exempt from all premarket notification requirements (i.e. 510(k) clearance). While the list includes product codes for ophthalmic and neurological devices, the majority of the devices are for clinical chemistry and clinical toxicology analyte controls.  

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New Publication by Dr. Chris Houston on Parenteral and Ophthalmic Drug Products

iuvo’s Director of Analytical Chemistry, Dr. Chris Houston, recently co-authored an article in the PDA Journal of Pharmaceutical Science and Technology entitled “Simulated Leaching (Migration) Study of a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.”

The article is available at http://journal.pda.org/content/71/2/68.full.pdf+html

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