Painchek (ASX:PCK) — Material Events
ASX:PCK · 20 articles in the last 12 months · 100% assessed
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Major ≥90
Significant 75–89
Notable 50–74
Routine <50
Not assessed
PainChek Breaks Ground with FDA Clearance and US Market LaunchHigh
PainChek secures FDA clearance, launches US market entry with strong ARR growth and Infant App expansion
26 Nov 2025
·AGM Presentation
·90
PainChek Breaks Into US Market with First Customer After FDA NodHigh
PainChek Secures First US Customer Following FDA De Novo Clearance, Targeting $100M Aged Care Market
13 Oct 2025
·ASX Announcement
·Unexpected
·90
PainChek’s FDA Clearance Unlocks $175M US Market and Infant App GrowthHigh
PainChek secures FDA clearance, expands US market access, and advances Infant App commercialization
31 Oct 2025
·Quarterly Activities and Cashflow Report
·90
PainChek Unlocks US$3bn RTM Market with FDA-Backed Reimbursement WinHigh
PainChek gains FDA-regulated status enabling US RTM reimbursement, unlocking multi-billion-dollar market opportunity
29 Jan 2026
·ASX Announcement
·90
PainChek FDA Clearance Unlocks $3B US Market with $5.6M ARR SaaS ModelHigh
PainChek FDA Cleared, $5.6M ARR SaaS with $3B US RTM Market Opportunity
30 Jan 2026
·Business Update
·90
PainChek Secures FDA De Novo Clearance, Unlocking $100M US Aged Care MarketHigh
PainChek Secures FDA De Novo Clearance, Unlocking $100M US Aged Care Market
8 Oct 2025
·Regulatory Approval Announcement
·Unexpected
·90
PainChek Raises A$7.5m, Eyes US FDA Clearance to Unlock $582M MarketHigh
PainChek raises A$7.5m, eyes US FDA clearance and international growth with strong license and revenue gains
31 July 2025
·Quarterly Activities and Cashflow Report
·90
PainChek Secures FDA De Novo Clearance, Unlocking US Market PotentialMedium
PainChek confirms FDA De Novo clearance for PainChek Adult App, promptly disclosed to ASX
16 Oct 2025
·ASX Aware Query Response
·90
PainChek Advances US FDA Clearance, Raises $7.5M to Fuel Global ExpansionHigh
PainChek reports revenue growth, narrows loss, advances US FDA clearance, raises $7.5M for expansion
29 Aug 2025
·Preliminary Final Report
·85
PainChek’s Scottish Trial Cuts Falls 40%, Projects £66M NHS SavingsMedium
PainChek's UK pilot shows strong clinical benefits and £66M healthcare savings, advancing global growth
17 Sept 2025
·Business Update
·85
PainChek Nears FDA Nod, Eyes $100M US Market for Dementia Pain AppHigh
PainChek completes final FDA submission for US market clearance, eyes $100M+ opportunity
21 July 2025
·Regulatory Update
·85
PainChek Secures FDA Clearance, Unlocking US $3bn RTM Market OpportunityMedium
PainChek gains FDA clearance for US RTM reimbursement, expands US market presence with strong global licence growth
30 Jan 2026
·Quarterly Activities and Cashflow Report
·85
PainChek Secures A$7.5m to Fuel US FDA Clearance and Global ExpansionHigh
PainChek raises A$7.5m placement to fund US FDA clearance and international expansion
28 July 2025
·Capital Raising
·85
PainChek Lands Major $5B Sabra REIT Deal for 20,000 North American BedsMedium
PainChek Secures Landmark Agreement with Sabra REIT for 20,000 Bed Deployment in North America
14 Apr 2026
·Commercial Agreement
·85
PainChek Secures FDA Clearance, Eyes US Market with $5.6M ARR GrowthHigh
PainChek achieves FDA clearance, expands US market entry, and grows ARR to $5.6M with Infant app launch
31 Oct 2025
·Quarterly Activities Report
·85
PainChek Secures FDA Clearance, Eyes US Market Despite Rising LossesMedium
PainChek reports half-year loss of AUD 4.7M; FDA clearance opens US market
27 Feb 2026
·Appendix 4D Half Year Report
·80
PainChek Raises A$5.5 Million Convertible Note to Fuel US GrowthMedium
PainChek raises A$5.5 million via convertible notes to fund US expansion and working capital
22 May 2026
·Capital Raising
·80
PainChek Taps Sasha Grant to Accelerate $15B Infant Pain App GrowthMedium
PainChek appoints Sasha Grant to lead growth of Infant App targeting $15B market
17 Oct 2025
·Key Appointment
·75
PainChek Powers 9% UK Growth with 4,000 New Licenses in Aged CareMedium
PainChek achieves 9% quarterly growth in UK aged care with 4,000 new licenses
26 Mar 2026
·Operational Update
·75
No articles in this tier for the last 12 months.
Market Mentions
7
- appeared in market wrap coverage
These are market wrap articles where Painchek (ASX:PCK) was mentioned. They reflect broader market coverage, not company-specific announcements.
Healthcare Wrap - Week 28 (6 July -> 10 July) 2026
11 July 2026
Healthcare Wrap - Week 21 (18 May -> 22 May) 2026
23 May 2026
Healthcare Wrap - Week 16 (13 Apr -> 17 Apr) 2026
18 Apr 2026
Healthcare Wrap - Week 13 (23 Mar -> 27 Mar) 2026
28 Mar 2026
Healthcare Wrap - Week 9 (23 Feb -> 27 Feb) 2026
28 Feb 2026