Two analyses, published on Monday in the Annals of Internal Medicine, suggest that Medtronic's Infuse product was associated with a small, increased risk of cancer, and that early published data on the trials underreported side effects and emphasized favorable results.
Thanks for the info.. I think that is why they had BMTI/WMGI do the Assay test and requested more data in the CRL regarding such potential issues. Luckily, there did not seem to be any issue with cancer and Augment. More noteworthy is the fact that I believe only one oral cancer was detected out of hundreds of thousands with Augments sister device Gem21s.
It appears we will not hear anything from the FDA until around August 5th being that seemingly it takes them 6 months to respond to the company. Wright submitted the 6 questions the FDA had on February 5th of this year and that was 6 months after they filed the new PMA.