The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Novasight Hybrid System is cleared for sale in the following jurisdictions (regulatory approvals referenced):
• United States: FDA 510(k) clearance (K172258)
• Canada: Health Canada medical device license (102500)
• Japan: PMDA medical device license (catheter: 30200BZX00040000, console + PIM: 30200BZX00039000)
ISI: conavi.com/novasight/isi
Accessibility Policy: conavi.com/novasight/accessibility-policy