A small start up developing promising diagnostics for NASH and other deadly diseases receives 510(k) approval within 50 days
Sonic Incytes engaged Novateur’s experienced FDA device regulatory experts to prepare their pre-submission to the FDA as well as accompanying the team to the FDA meetings.
As a result of this engagement Sonic Incytes received 510(k) approval by the FDA within an impressive timeline of 50 days, which was far ahead of schedule.
Under a separate mandate, Sonic Incytes engaged Novateur’s reimbursement experts to assess commercial viability of their products as well as identifying the required reimbursement codes for the company.
"I found working with Novateur an absolute pleasure. They were flexible and responsive to the unique needs of a startup, and ensured we met our timeline. I feel more confident in achieving our upcoming FDA clearance and launching in the US market."
CEO, Sonic Incytes