Exact Sciences (Madison, Wisconsin) said it has submitted to the FDA the final module of its PMA application for Cologuard, the company's stool DNA (sDNA) colorectal cancer screening test. The final module, which is comprised of data from the company's DeeP-C clinical trial, completes the company's PMA application for the product.
It's no secret that Latin America's regulatory climate can be challenging for many healthcare product companies. But just what are in the ins and outs for the medical device market in Latin America and how are med-tech companies impacted? Regulatory Affairs Professionals Society (RAPS; Rockville, Maryland) held a webcast last week to explore the latest regulations and updates along with their potential impact on companies doing business in Argentina, Brazil and Mexico.
In a recent conversation with one of my good friends who has been in the music industry off and on for 20+ years, I realized that there are some glaring similarities between that form of entertainment and med-tech. Consider this quote from my friend if you will: "Nowadays Omar, you have to create a buzz around yourself. You have to get people's attention and do most of the leg work yourself before a major label (distributor) will even look at you, or invest in you." When he said this, I began thinking about how difficult it was to get funding...
EBS Technologies (Berlin), an emerging firm developing the Next Wave brain stimulation platform for treatment of vision deficits caused by neurological disorders, reported the results of a multi-center, 82-patient clinical trial of the device.
