Catalysts
| Clinical data
| Regulatory events
| M & A
2025
Q4
Anteris Technologies (AVR): IDE Approval (DurAVR) (n=1000) ✓
Artrya (AYA): 510(k) FDA Submission (Salix Coronary Flow Module)
BlinkLab (BB1): Pivotal 510(k) Pilot-Phase Readout (n=485) ✓
Cleo Diagnostics (COV): Pivotal 510(k) Readout (n=500)
Echo IQ (EIQ): Mayo Clinic Platform Validation Study Readout and 510(k) FDA Submission (EchoSolv HF) ✓
Inoviq (IIQ): In-House Retrospective Study Readout (EXO-OC) (n=500)
Polynovo (PNV): Pivotal PMA BARDA Study Readout (n=120) and FDA Submission
Anteris Technologies (AVR): IDE Approval (DurAVR) (n=1000) ✓
Artrya (AYA): 510(k) FDA Submission (Salix Coronary Flow Module)
BlinkLab (BB1): Pivotal 510(k) Pilot-Phase Readout (n=485) ✓
Cleo Diagnostics (COV): Pivotal 510(k) Readout (n=500)
Echo IQ (EIQ): Mayo Clinic Platform Validation Study Readout and 510(k) FDA Submission (EchoSolv HF) ✓
Inoviq (IIQ): In-House Retrospective Study Readout (EXO-OC) (n=500)
Polynovo (PNV): Pivotal PMA BARDA Study Readout (n=120) and FDA Submission
2026
Q1
Cleo Diagnostics (COV): 510(k) FDA Submission
Echo IQ (EIQ): 510(k) FDA Submission Result (EchoSolv HF)
Cleo Diagnostics (COV): 510(k) FDA Submission
Echo IQ (EIQ): 510(k) FDA Submission Result (EchoSolv HF)
Q2
Anteris Technologies (AVR): CE Mark Submission (DurAVR)
BlinkLab (BB1): Pivotal 510(k) Main-Phase Readout (n=560) and FDA Submission
Anteris Technologies (AVR): CE Mark Submission (DurAVR)
BlinkLab (BB1): Pivotal 510(k) Main-Phase Readout (n=560) and FDA Submission