510(k) or PMA?
Thursday, March 3, 2011 at 5:06PM Nanosonics innovative Trophon EPR achieves US market entry with a 510(k)
Nanosonics Trophon EPRAdvances in technology fall into two camps; Evolutionary development or Disruptive game changers. Safe, non-toxic and fast disinfection of ultrasound probes was gaining gradual improvement until the development of Nanosonics Trophon EPR. Here was the disruptive solution the market needed; the superb performance is like nothing else!
Everyone knows you can’t have your cake and eat it, too. Wouldn’t a disruptive solution need a costly PMA to be sold in the US? This was the challenge faced by our client Nanosonics. With thoughtful approaches to meet US regulatory demands and extensive communication with the FDA, Brandwood Biomedical is delighted that a carefully created submission has resulted in a 510(k) issued on the basis that the stated use has substantial equivalence to predicates.
Brandwood Biomedical congratulates all the team at Nanosonics on achievement of access to the US market, and looks forward to news of American customer delight and commercial success for the company.
By the way, if you want to read an interesting book on how the best companies achieve great outcomes in seemingly contradictory or counterintuitive circumstances, have a look at “Doing Both: How Cisco Captures Today's Profit and Drives Tomorrow's Growth” by Inder Sidhu.
