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Friday, April 15, 2011. Back after a month away. The follwing item appeared todaty that is directly related to the last item we posted here. FDA's Medical Device Review Scrutinized at Senate Hearing. Recent study suggests that high-risk medical devices were recalled at a rate of 1.4 devices for every one U.S. resident in the first six months of 2010. Kohl opened the hearing by emphasizing that "the FDA must constantly strive to maintain a delicate balance between safety and innovation.". Internal reviews...

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Friday, April 15, 2011. Back after a month away. The follwing item appeared todaty that is directly related to the last item we posted here. FDA's Medical Device Review Scrutinized at Senate Hearing. Recent study suggests that high-risk medical devices were recalled at a rate of 1.4 devices for every one U.S. resident in the first six months of 2010. Kohl opened the hearing by emphasizing that the FDA must constantly strive to maintain a delicate balance between safety and innovation.. Internal reviews...

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back to blogging,posted by,rainfo blog,no comments,email this,blogthis,share to twitter,share to facebook,share to pinterest,reactions,maybe demoninators,imho,aboutlawsuits com,6 comments,fda law blog,digital pathology blog,an earlier post,development

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RAinfo | rainfoblog.blogspot.com Reviews

https://rainfoblog.blogspot.com

Friday, April 15, 2011. Back after a month away. The follwing item appeared todaty that is directly related to the last item we posted here. FDA's Medical Device Review Scrutinized at Senate Hearing. Recent study suggests that high-risk medical devices were recalled at a rate of 1.4 devices for every one U.S. resident in the first six months of 2010. Kohl opened the hearing by emphasizing that "the FDA must constantly strive to maintain a delicate balance between safety and innovation.". Internal reviews...

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rainfoblog.blogspot.com

1

RAinfo: FDA approves first 3-D mammography imaging system

http://rainfoblog.blogspot.com/2011/02/fda-approves-first-3-d-mammography.html

Friday, February 11, 2011. FDA approves first 3-D mammography imaging system. Feb 11, 2011. Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov. FDA approves first 3-D mammography imaging system. Selenia Dimensions System may boost accuracy in breast cancer detection,. The US. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. The National...

2

RAinfo: Digital Pathology Blog

http://rainfoblog.blogspot.com/2011/02/digital-pathology-blog.html

Friday, February 11, 2011. Http:/ tissuepathology.typepad.com/weblog/. January 25, 2011. Standardization and Validation of Digital Pathology in Clinical Laboratories. The following post was submitted by Dr. Holger Lange, CTO of Flagship Biosciences, who is working with a number of pharmaceutical partners on regulatory companion diagnostics. These are the subjects that are covered in the presentation:. Medical Device Manufacturer Regulations. With an example of a successful study design. A discussion ...

3

RAinfo: Comments on the FDA Innovation Pathway

http://rainfoblog.blogspot.com/2011/02/comments-on-fda-innovation-pathway.html

Friday, February 18, 2011. Comments on the FDA Innovation Pathway. Hyman, Phelps and McNamara, P.C. Nothing New: FDA Announces its Innovation Pathway Program for Breakthrough Technologies. Posted: 14 Feb 2011 10:39 PM PST. By Jeffrey K. Shapiro. FDA’s Center for Devices and Radiological Health (“CDRH”) has proposed the “ Innovation Pathway Program. Color us skeptical. Not about the DARPA product. We’re talking about the Innovation Pathway Program. It has not very worked well. On the Innovation Pathway pr...

4

RAinfo: February 2011

http://rainfoblog.blogspot.com/2011_02_01_archive.html

Friday, February 18, 2011. A recent post about recalls and 510(k) - What's missing? A recent published article takes the FDA's 510(k) process to task showing that "Most Recalled Medical Devices Went through FDA Fast-Track Process". A finding of the referenced study is stated that " findings reveal critical flaws in the current FDA device review system. Perhaps someone should educate the article authors about the concept of demoninators and a smewhat critical flaw in their analysis. Denominator = 17,733 5...

5

RAinfo: April 2011

http://rainfoblog.blogspot.com/2011_04_01_archive.html

Friday, April 15, 2011. Back after a month away. The follwing item appeared todaty that is directly related to the last item we posted here. FDA's Medical Device Review Scrutinized at Senate Hearing. Recent study suggests that high-risk medical devices were recalled at a rate of 1.4 devices for every one U.S. resident in the first six months of 2010. Kohl opened the hearing by emphasizing that "the FDA must constantly strive to maintain a delicate balance between safety and innovation.". Internal reviews...

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Friday, April 15, 2011. Back after a month away. The follwing item appeared todaty that is directly related to the last item we posted here. FDA's Medical Device Review Scrutinized at Senate Hearing. Recent study suggests that high-risk medical devices were recalled at a rate of 1.4 devices for every one U.S. resident in the first six months of 2010. Kohl opened the hearing by emphasizing that "the FDA must constantly strive to maintain a delicate balance between safety and innovation.". Internal reviews...

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