Greenleaf Health worked with a multinational medical device company throughout the review and submission of a breakthrough device designation request for a device indicated for the minimally invasive treatment of lung tumors. The Greenleaf team provided strategic advice on how to frame the device description and indication for the breakthrough request in light of the company’s prior clearances for related technologies. Greenleaf also reviewed the complete breakthrough request, providing feedback on how to strengthen the justifications for each breakthrough criterion and advice on what types of data to include.
After submitting the request, the company received questions from the FDA regarding the device’s indication. Greenleaf reviewed the FDA’s questions and provided recommendations on how to revise the indication, discussing potential options with the company in order to determine the most appropriate strategy. The Greenleaf team then worked with the company to revise their breakthrough request and prepare for discussions with the FDA review team. The revisions and subsequent interactions with the Agency succeeded in resolving the review issue, and the company achieved a breakthrough designation for their device.