|Sep 19, 2017|
WSI Device Clearances After the Philips De Novo Classification | An Outlook on the Regulatory Road Ahead
With the recent shift in the industry as the result of this decision, a common question is “What lies in store for digital pathology system manufacturers in the wake of the FDA granting Philips’ de novo classification request for its IntelliSite device?”
First, What is De Novo?
Manufacturers will continue to push the envelope now that WSI devices are cleared for primary diagnosis in the USA. What innovations could trigger another de novo, or even a PMA? Some possibilities are:
Speaking of Medical Device Development Tools…