According to the reports, the Food and Drug Administration of US has proposed a new way for breakthrough medical devices to be approved by the agency.
On Tuesday, in a briefing agency officials said that a new Innovation Pathway is part of an initiative designed to help cutting-edge products win quicker clearance than earlier.
“The new pathway isn't an ordinary proposal and not the usual from a regulatory agency", said FDA device Chief Dr. Jeffrey Shuren. According to Shuren, the new initiative is like "a sea change in the way we approach public health."
Ubl, a Minnesota native said, "We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process. The problems with the process "needlessly delay patient access to life- saving, life-enhancing medical technology."
New Brighton based Acorn raised around $110 million to develop a novel device to treat heart failure. However, it has failed to gain FDA approval after a decade of wrangling with the agency.
According to The new Innovation Pathway, the FDA will get involved early with companies developing a novel product. This program would be used for a relatively small subset of medical devices, which provide significant improvement over current treatments.












