Most Clicked AATB SmartBrief Stories

1. FDA proposes adverse-event reporting guidance for cellular, tissue products

AATB SmartBrief | Feb 25, 2015

The FDA has released new draft guidelines describing the kinds of adverse events related to the use of human cells, tissues and cellular and tissue-based products that should be reported to the FDA, and how establishments should report the events. The report should be filed by the establishment that makes HCT/Ps available for distribution, and it should be done within 15 days of discovering the event, the agency said. Regulatory Focus (02/19)

2. Researchers report new technique for extended joint tissue preservation

AATB SmartBrief | Feb 04, 2015

University of Missouri researchers said they have developed a technique that more than doubles the storage life of donated tissues used in joint replacement compared with existing methods. The Missouri Osteochondral Allograft Preservation System involves a novel preservation solution for use at room temperature, according to the study team's report in the journal Clinical Orthopaedics and Related Research. Genetic Engineering & Biotechnology News (01/29)

3. FDA unveils final guidance on medical device data systems

AATB SmartBrief | Feb 11, 2015

Medical device data systems that are used to display, store, receive or transfer medical information will not be regulated by the FDA, as they pose a low risk to users, the agency announced Friday when it released the final version of its guidance for the systems. "This is a very natural extension from the recent FDA guidance on accessories where FDA acknowledges that the risk associated with an accessory is not necessarily the same as the risk of the parent medical device," said attorney Brad Thompson, a specialist in FDA regulation. VentureBeat (02/06)

4. Researchers develop new method for producing donor-derived artificial skin

AATB SmartBrief | Feb 18, 2015

Researchers said they have developed a new way of making artificial skin using human skin from a donor who is a close match for the patient. The study team transferred the patent for the technology to the Euro Tissue Bank and the University Hospital Ghent in Belgium. (Netherlands) (02/16)

5. Cornea transplants and restored vision inspire artist

AATB SmartBrief | Feb 11, 2015

Cornea transplants helped restore the vision of Adam Kolp, an art teacher at New Albany Middle School in Ohio, and his experience provided the inspiration for his first solo art showing. Kolp was diagnosed with keratoconus at a young age and lost his vision during college. Kolp's show is titled "A Gift of Clarity," and it includes works that depict his experiences after he lost his eyesight. (Lewis Center, Ohio) (02/03)

6. Aggressive HIV strain found in Cuba

AATB SmartBrief | Feb 18, 2015

An aggressive strain of HIV has been found in Cuba, with the virus progressing to AIDS within three years, according to a study in the journal EBioMedicine. The CRF19 strain has elements of HIV subtypes A, D and G, according to the researchers. (02/15) Miami Herald (tiered subscription model), The (02/14)

7. Come to the Quality and Donor Suitability Workshop -- and submit a case study

AATB SmartBrief | Feb 04, 2015

The 2015 Quality and Donor Suitability Workshop will be held April 20-22 at the Sheraton Atlanta Hotel in Atlanta. This educational and interactive workshop will include roundtable discussions, challenging case studies and more -- register now! To submit a case study, download and complete one of the following forms and e-mail it to Scott Brubaker: 2015 Case Study for Donor Suitability Form; 2015 Case Study for Quality Management Form. Blank (12/10)

8. Minn. play aims to raise awareness on tissue, organ donation

AATB SmartBrief | Feb 11, 2015

Star Tribune (Minneapolis-St. Paul, Minn.) (02/10)

9. Study: Ebola virus survives up to 7 days after patient's death

AATB SmartBrief | Feb 18, 2015

The Ebola virus remains alive on body surfaces for up to seven days and in tissue samples for up to three days after death, according to a study of macaques in the journal Emerging Infectious Diseases. Researchers tested the bodies in conditions that simulated the environment of West Africa. Medical News Today (02/13)

10. More than 350 people reach out about donating liver for young twins

AATB SmartBrief | Feb 04, 2015 (02/03)

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