1. Home
  2. News
  3. PainChek Ltd
  4. PainChek has productive final FDA De Novo clearance meeting
More PainChek Ltd news
PainChek LtdASX: PCK

PainChek has productive final FDA De Novo clearance meeting

Jun 4, 2025 at 10:53 PM EDT · Issued by PainChek Ltd

Filed with ASX · Jun 4, 2025 at 10:53 PM EDT · 3 pages · English

On 6ix: 6ix.com/news/painchek-has-productive-final-fda-de-novo-clearance-meeting

PainChek Ltd on 6ix

Story so far

  • PCK submits application for Adult App FDA De Novo clearanceNov 20, 2024
  • PainChek Adult app FDA De Novo submission updateOct 2, 2024
  • US nursing home study to pave way for FDA De Novo clearanceAug 24, 2023

Earlier from PainChek

  • PainChek partners with Eldermark to expand US market reachMay 26, 2025
  • R&D Tax Refund, FDA Review of Adult App & Infant App LaunchApr 15, 2025
  • PainChek completes Entitlement Offer raising AUD $5.1 mDec 16, 2024
  • PainChek Implementations, Market and International ExpansionDec 10, 2024
  • ProspectusNov 24, 2024

Later from PainChek

  • PainChek Reports Strong Quarterly Sales GrowthJul 2, 2025
  • Final US FDA De Novo Clearance Submission CompletedJul 20, 2025
  • Strongly Supported A$7.5m Placement to Drive Int. GrowthJul 28, 2025
  • Preliminary Final ReportAug 28, 2025
  • Compelling Clinical and Economic Results in Scottish PilotSep 16, 2025
All PainChek news releases↗

Follow PainChek into a list and get an email when it puts out news.

Follow PainChek
  • About 6ix
  • Editorial & Sourcing
  • Corrections
  • Contact
  • Privacy
  • Terms
  • Disclaimer