Catalysts
    | Clinical data
    | Regulatory events
    | M & A

2025

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Q4
​
Anteris Technologies (NASDAQ: AVR): IDE Approval (DurAVR) (n=1000)   ✓
​BlinkLab (ASX: BB1): Pivotal 510(k) Pilot-Phase Readout (n=485)   ✓
Echo IQ (ASX: EIQ): Mayo Clinic Platform Validation Study Readout and 510(k) FDA Submission (EchoSolv HF)   ✓
HeartBeam (NASDAQ: BEAT): 510(k) FDA Result (12-Lead ECG Synthesis Software)   ✓

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2026

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Q1

Artrya (ASX: AYA): 510(k) FDA Submission (Salix Coronary Flow Module)
Artrya (ASX: AYA): 510(k) FDA Result (Salix Coronary Flow Module)
BlinkLab (ASX: BB1): Preliminary European ADHD Study Readout (BlinkLab Dx2)
​Cleo Diagnostics (ASX: COV): 510(k) FDA Submission
Echo IQ (ASX: EIQ): 510(k) FDA Result (EchoSolv HF)
Inoviq (ASX: IIQ): In-House Retrospective Study Readout (EXO-OC) ​(n=500)

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Q2

Anteris Technologies (NASDAQ: AVR): CE Mark Submission (DurAVR)
BlinkLab (ASX: ​BB1): Pivotal 510(k) Main-Phase Readout (n=560) and FDA Submission

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Q3

BlinkLab (ASX: BB1): Pivotal 510(k) FDA Result (BlinkLab Dx1)
PolyNovo (ASX: ​PNV): Pivotal 510(k) FDA Submission (Syntrel)

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