Tag Archives: Medical Imaging Software

March 12, 2012 by Dane Stout

Building the Cathedral of Personalized Medicine One Sample at a Time

Anson’s culture is one that puts high value and importance on giving back to the community and society as part of measuring its value return on business.   Anson employees are encouraged to give back to the community, and even have an allocation of work time available to serve in this capacity.

On Saturday a number of Anson employees participated in an event sponsored by the Komen Tissue Bank affiliated with the Simon Cancer Center at the Indiana University Medical School.   Not only did they donate of their time, but literally of themselves; the Komen Tissue Bank is the only known tissue bank focused exclusively on the collection of healthy breast tissue samples to share with research scientists around the world as they conduct meta-analysis research on the complex triggers of the varied forms of breast cancer.    Healthy donor tissue samples are of vital importance to this research, and yet one might think it’s difficult to find healthy people in today’s hectic society who are willing to take the time and suffer some discomfort related to tissue sample collection procedures.   One would be wrong. 

For these Anson employees, and indeed, for thousands of others like them, this is a expression of caring about the community and the cause.  For example, The Army of Women is a program launched by the Dr. Susan Love Research Foundation, with the explicit goal of recruiting one million women to participate in breast cancer research.  According to the web site, the Army of Women has two primary goals:

  • To recruit one million healthy women of every age and ethnicity, including breast cancer survivors and women at high-risk for the disease, to partner with breast cancer researchers and directly participate in the research that will eradicate breast cancer once and for all.
  • To challenge the scientific community to expand its current focus to include breast cancer prevention research conducted on healthy women.

Bioinformatics research is a complex process and requires access to enormous amounts of data, computing power, and biological samples in order to provide statistically relevant insights into the study of disease and the genomic clues to its mechanisms.   The overall enormous and complex, but the sources of samples aren’t; its simply individual people that have a passion and care about others. 

This reminds me of the classic story about a vistor to a city where many stone cutters were working. Approaching several of the cutters, he asked them the same question: “What are you doing?” The first stonecutter he met replied, “I’m cutting stone. It’s dull work, but it pays the bills.”  A second stonecutter responded, “I’m the best stone cutter in the land. Look at the smoothness of this stone, how perfect the edges are.”  A third pointed to a foundation several yards away, and said, “I’m building a cathedral.”

Hat’s off to my colleagues and friends here at Anson who on Saturday made their own contributions to the Personalized Medicine Cathedral.   Great job.

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March 9, 2012 by Dane Stout

Anson Group is a Proud Sponsor of Kids Against Hunger

Did you know that every 6 seconds a child dies from hunger related disease?  Anson is proud to be a corporate sponsor for the first ever Zionsville area Kids Against Hunger packing event on March 10, 2012.   If you’re not …

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January 26, 2012 by Dane Stout

Health In Place offically launched and running

I’m very pleased and honored to be selected to serve on the Board of Advisors for Health in Place, an initiative to develop a new approach to considering innovations which impact health: ➪across the generations, recognizing the unique needs at …

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September 9, 2011 by Allison Scott

Case Study: Anson Revises Regulatory Strategy to Obtain Fast 510(k) Clearance

As I’ve previously reported in past blogs, the average review time for 510(k)s is about 140 days with about 2 review cycles.  This week, with the help of Anson, a small device manufacturer obtained FDA Clearance on a Traditional 510(k) …

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August 11, 2011 by Allison Scott

LOWER User Fee Payments!

Last August, I reported that FDA had begun negotiations with Congress to set the amounts to be charged as medical device user fees for FY 2013. Although decisions have not yet been reached for that fiscal year, FDA announced last …

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July 29, 2011 by Allison Scott

IOM Press Conference Highlights

The Institute of Medicien (IOM) press conference on their report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years was held this morning. In the opening remarks it was noted that the conclusions presented within …

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July 29, 2011 by Allison Scott

Could this be the end of the 510(k) process?!

The long awaited IOM report to FDA has been released as of 9AM EDT today. The Institute of Medicine (IOM) had been tasked with evaluating the 510(k) clearance process for medical devices and to answer two questions: Does the current …

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July 28, 2011 by Allison Scott

FDA 510(k) Reviews Result in More Questions Than Ever

Last month, I reported on FDA review times and how they’ve increased 34% since 2006. The main cause attributed to the increase in review times is the data necessary for FDA to evaluate the safety and efficacy of the device …

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July 27, 2011 by Allison Scott

New FDA Guidance on 510(k) Device Modifications

Last year FDA reviewed the 510(k) process and released two reports, which included recommendations for improving predictability, consistency, and transparency in the process. As a result of its review, FDA has issued a number of new draft guidance documents, including …

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July 26, 2011 by Patrick Mooney

Corrections and Removals

PDF: Corrections and Removals (21CFR 806) A discussion of when medical device corrections and removals must be submitted to FDA

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