CytoSorbents Corporation (CTSO)

[raptorjockey]

CytoSorb received FDA Breakthrough Designation to remove Ticagrelor during emergent or urgent cardiothoracic surgery, in April, 2020.

From the FDA intro to Breakthrough Devices Program:

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products2 that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is a va ila ble for devices and device-led combination products which are subject to review under a premarket approval application (P MA), premarket notification (510(k)), or De Novo classification request(“De Novo request”). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission3 to protect and promote public health.

Section 515B of the FD&C Act states that Breakthrough Device designation may be requested “any time prior to the submission of an application under section 515(c) [21 U.S.C 360e(c)], a notification under section 510(k) [21 U.S.C. 360(k)], or a petition for classification under section 513(f)(2) [21 U.S.C. 360c(f)(2)]. Therefore, as part of the designation request review, FDA considers whether the expected marketing application for the device is a PMA, 510(k), or De Novo request.

It has been 6 months since achieving Breakthrough Designation. So far, unless I missed it, we have not been notified whether we have received the PMA, 510k or De Novo. I can't see this detail taking longer than 30 days to decide, this is an important detail regarding the application, Thoughts? Techxen is usually on top of Cytosorbents details, yet he has been quiet now since middle of August. Anyone have word on his status?