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PAINCHEK LTD

0.330

0.000

Volume:222.78K

Turnover:73.40K

Market Cap:68.91M

PE:-7.47

High:0.340

Open:0.335

Low:0.325

Close:0.330

52wk High:1.050

52wk Low:0.240

Shares:208.81M

Float Shares:151.37M

Volume Ratio:1.67

T/O Rate:0.15%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.044

EPS(LYR):-0.044

ROE:-8647.59%

ROA:-151.46%

PB:-61.91

PE(LYR):-7.47

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Overview Company News Filings

BRIEF-PainChek Secures First US Customer After FDA Clearance

Should FDA De Novo Clearance for Adult App Prompt a Rethink by PainChek (ASX:PCK) Investors?

Simply Wall St.

ASX Midday Sector Update: Healthcare Sector Up, Consumer Discretionary Falls

MT Newswires Live

BRIEF-Painchek Says FDA De Novo Grant Received For Pain Assessment App

BUZZ-Australia's PainChek Ltd hits over 5-year high after US FDA approves pain app

PainChek Ltd - FDA De Novo Grant Received for Pain Assessment App

THOMSON REUTERS

BRIEF-Painchek Seeks Trading Halt Pending FDA Clearance

PainChek Ltd - Seeks Trading Halt Pending FDA Clearance

THOMSON REUTERS

PainChek Says Scotland Care System Trial Confirmed Clinical Benefits from App Use, Shares Up 4%

MT Newswires Live

PainChek Ltd-Quarterly Update & Appendix 4C Webinar

THOMSON REUTERS

BRIEF-Painchek Says A$7.5M Placement To Drive International Growth With US FDA Clearance Expected Near Term

PainChek - a$7.5M Placement to Drive International Growth With US FDA Clearance Expected Near Term

THOMSON REUTERS

BRIEF-Painchek Seeks Trading Halt Until Capital Raising Announcement

PainChek Ltd - Trading Halt Until PainChek Announces Capital Raising

THOMSON REUTERS

PainChek Completes Submission for US FDA De Novo Regulatory Clearance for App; Shares Up 3%

MT Newswires Live

Notification of cessation of securities - PCK-PCK.AX

Change in Directors' Interest Notice x 5-PCK.AX

Notification regarding unquoted securities - PCK-PCK.AX

PainChek Says Contracted Annual Recurring Revenue Rises 10% in June Quarter

MT Newswires Live

BRIEF-Painchek Posts Contracted Annual Recurring Revenue Of A$5.4 Million For Quarter

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PainChek Ltd PCK.AX:SECURES FIRST US CUSTOMER AFTER FDA CLEARANCEFurther company coverage: PCK.AX ((Reuters.Briefs@thomsonreuters.com;))","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251013:nFWN3VR2VD:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2574439349","title":"Should FDA De Novo Clearance for Adult App Prompt a Rethink by PainChek (ASX:PCK) Investors?","url":"https://stock-news.laohu8.com/highlight/detail?id=2574439349","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2574439349?lang=en_us&edition=fundamental","pubTime":"2025-10-11 10:19","pubTimestamp":1760149152,"startTime":"0","endTime":"0","summary":"PainChek has received De Novo clearance from the US FDA for its Adult App, authorizing it as the first regulated medical device for pain assessment in individuals who cannot reliably self-report, including those with dementia, thus unlocking access to the US aged care market.\nThe clearance not only enables immediate US commercial rollout but also paves the way for expanded opportunities in international markets that recognize FDA data standards, such as Japan and Germany.\nWe'll now explore...","market":"sg","thumbnail":"https://images.simplywall.st/asset/industry/9551730-choice1-main-header/1585186828574","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/9551730-choice1-main-header/1585186828574"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/au/healthcare/asx-pck/painchek-shares/news/should-fda-de-novo-clearance-for-adult-app-prompt-a-rethink","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/au/healthcare/asx-pck/painchek-shares/news/should-fda-de-novo-clearance-for-adult-app-prompt-a-rethink","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"simplywall_highlight","symbols":["PCK","ISBC","BK7094","PCK.AU","BK4211"],"gpt_icon":0},{"id":"2573915442","title":"ASX Midday Sector Update: Healthcare Sector Up, Consumer Discretionary Falls","url":"https://stock-news.laohu8.com/highlight/detail?id=2573915442","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573915442?lang=en_us&edition=fundamental","pubTime":"2025-10-08 10:52","pubTimestamp":1759891923,"startTime":"0","endTime":"0","summary":"Healthcare stocks advanced 0.5% at midday Wednesday.On Wall Street, the S&P 500 fell 0.4%, the Dow Jones index slipped 0.2%, and the Nasdaq index shed 0.7%.PainChek  was granted a De Novo classification by the US Food and Drug Administration for its PainChek pain assessment adult app. The US FDA created product code \"SGB,\" recognizing the app as a unique medical device for pain assessment.The FDA De Novo classification increases the potential for expedited regulatory approval in Japan as well as other global markets, such as Brazil and the United Arab Emirates, that accept FDA approval to facilitate abbreviated market entry.On the flip side, the consumer discretionary sector fell 1.7%, as Australian stocks continued to decline.Peter Warren Automotive Holdings  said that Chief Financial Officer Victor Cuthell plans to retire in June 2026. The company has initiated a process to identify a successor and ensure a smooth transition.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK7094","BK4137","PCK.AU","LABU","XLV","HCSG","BK4585","BK4588","BK4581","BK7143","XBI","PWR.AU"],"gpt_icon":0},{"id":"2573918694","title":"BRIEF-Painchek Says FDA De Novo Grant Received For Pain Assessment App","url":"https://stock-news.laohu8.com/highlight/detail?id=2573918694","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573918694?lang=en_us&edition=fundamental","pubTime":"2025-10-08 09:27","pubTimestamp":1759886871,"startTime":"0","endTime":"0","summary":"BRIEF-Painchek Says FDA De Novo Grant Received For Pain Assessment AppOct 8 (Reuters) - PainChek Ltd PCK.AX:FDA DE NOVO GRANT RECEIVED FOR PAIN ASSESSMENT APPFurther company coverage: PCK.AX ((Reuters.Briefs@thomsonreuters.com;))","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251008:nFWN3VO2NB:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2573990363","title":"BUZZ-Australia's PainChek Ltd hits over 5-year high after US FDA approves pain app","url":"https://stock-news.laohu8.com/highlight/detail?id=2573990363","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573990363?lang=en_us&edition=fundamental","pubTime":"2025-10-08 08:45","pubTimestamp":1759884305,"startTime":"0","endTime":"0","summary":"BUZZ-Australia's PainChek Ltd hits over 5-year high after US FDA approves pain app** Shares of Australia's PainChek Ltd PCK.AX rise as much as 31.3% to A$0.105, their highest level since mid-August 2020** Stock posts its biggest intraday pct gain since early-October 2023** Medical technology firm says U.S. FDA granted De Novo classification for its PainChek Adult App** PainChek Adult App is a smartphone-based pain assessment tool designed for individuals who cannot self-report pain, such as those with moderate to severe dementia** De Novo classification refers to regulatory pathway used by the FDA to evaluate and approve novel medical devices that do not have an existing legally marketed equivalent** Nearly 18.5 million shares change hands, 4.9x the 30-day average volume ** Stock has risen 186.2% this year, including session gains ","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251008:nL3N3VP00T:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7094","PCK.AU"],"gpt_icon":0},{"id":"2573723992","title":"PainChek Ltd -  FDA De Novo Grant Received for Pain Assessment App","url":"https://stock-news.laohu8.com/highlight/detail?id=2573723992","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573723992?lang=en_us&edition=fundamental","pubTime":"2025-10-08 08:00","pubTimestamp":1759881604,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251008:nFWN3VO2NB:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK7094","PCK.AU"],"gpt_icon":0},{"id":"2573498900","title":"BRIEF-Painchek Seeks Trading Halt Pending FDA Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2573498900","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2573498900?lang=en_us&edition=fundamental","pubTime":"2025-10-07 06:24","pubTimestamp":1759789472,"startTime":"0","endTime":"0","summary":"BRIEF-Painchek Seeks Trading Halt Pending FDA ClearanceOct 7 (Reuters) - 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PainChek Ltd PCK.AX:A$7.5M PLACEMENT TO DRIVE INTERNATIONAL GROWTH WITH US FDA CLEARANCE EXPECTED NEAR TERMFurther company coverage: PCK.AX ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250728:nFWN3TM21M:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"shareholding","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["PCK.AU","BK7094"],"gpt_icon":0},{"id":"2554498677","title":"PainChek -  a$7.5M Placement to Drive International Growth With US FDA Clearance Expected Near Term","url":"https://stock-news.laohu8.com/highlight/detail?id=2554498677","media":"THOMSON REUTERS","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2554498677?lang=en_us&edition=fundamental","pubTime":"2025-07-28 07:59","pubTimestamp":1753660755,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250727:nFWN3TM21M:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"shareholding","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK7094","PCK.AU"],"gpt_icon":0},{"id":"2553226326","title":"BRIEF-Painchek Seeks Trading Halt Until Capital Raising Announcement","url":"https://stock-news.laohu8.com/highlight/detail?id=2553226326","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2553226326?lang=en_us&edition=fundamental","pubTime":"2025-07-24 07:24","pubTimestamp":1753313048,"startTime":"0","endTime":"0","summary":"BRIEF-Painchek Seeks Trading Halt Until Capital Raising AnnouncementJuly 24 (Reuters) - 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