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Predictmedix Announces Completion of 1600-Person Clinical Study for Safe Entry's Medical Device Regulatory Approval in Indonesia

Predictmedix Announces Completion of 1600-Person Clinical Study for Safe Entry's Medical Device Regulatory Approval in Indonesia

Predictmedix 宣佈在印尼完成 1600 人臨床研究,以獲得安全進入的醫療器械監管批准
Accesswire ·  2023/03/08 20:06
  • The 1600-person study at a prestigious University in Jakarta, Indonesia prepares Predictmedix's Safe Entry for regulatory approval listed as a 'Medical Device'
  • Medical device classification allows Predictmedix to commercialize Safe Entry at scale in Indonesia
  • Third-party clinical validation yet another milestone for Predictmedix's AI-Powered screening technology
  • 在印度尼西亞雅加達一所著名大學進行的 1600 人研究為 Predictmedix 的安全進入準備,以獲得被列為「醫療設備」的監管批准
  • 醫療器械分類允許 Predictmedix 在印尼大規模安全進入商業化
  • 第三方臨床驗證又是 Predictmedix 人工智慧篩選技術的又一里程碑

TORONTO, ON / ACCESSWIRE / March 8, 2023 / Predictmedix Inc. ("Predictmedix" or the "Company") (CSE:PMED) (OTCQB:PMEDF) (FRA:3QP), an emerging provider of rapid health screening solutions powered by a proprietary artificial intelligence (AI), today announced the completion of a 1600-person clinical study taken place at a prominent University in Indonesia for the purpose of validating the company's AI-powered non-invasive screening technology in order to prepare for the regulatory approval application to classify Safe Entry as a medical device.

多倫多,交通線路/2023 年 3 月 8 日/ 由專有人工智慧 (AI) 提供支援的新興快速健康篩查解決方案供應商 Predictmedix Inc. (OTCQB: PMEDF) (FRA: 3QP),今天宣佈完成在印尼一所著名大學進行的 1600 人臨床研究,用於驗證該公司。為了準備監管批准申請的技術,將安全進入歸類為醫療儀器。

As the company's commercialization efforts are underway in Indonesia, having Safe Entry classified as a Medical Device is an integral step to scaling into the landscape of the Indonesian market. The third-party validation of the company's AI-powered screening technology marks yet another milestone for the efficacy of Safe Entry.

隨著該公司在印尼的商業化工作正在進行中,將安全入口歸類為醫療器械是擴展印尼市場格局的不可或缺的一步。該公司採用人工智慧篩選技術的第三方驗證,標誌著安全入境功效的又一個里程碑。

The National Agency of Drug and Food Control (NADFC) under the Indonesian Ministry of Health (MoH) regulates medical devices. The organization overseas all pre-market and post-market evaluation, standardization, legislation, and Good Manufacturing Practices (GMP) certification. All Medical Devices and IVDs (In Vitro Diagnostics) must receive a registration number and product license issued by the Ministry of Health to a local licensed distributor before import. Due to the non-invasive nature of Predictmedix's Safe Entry unit, the approval process is not expected to take a significant amount of time. The University is expected to begin the certification process within the month of March of 2023.

印度尼西亞衛生部(MoH)國家藥品和食品控制局(NADFC)對醫療設備進行了規管。該組織在海外的所有上市前和上市後評估,標準化,立法和良好生產規範(GMP)認證。所有醫療設備和 IVD(體外診斷)必須在進口前獲得衛生部頒發給當地許可分銷商的註冊號和產品許可證。由於 Predictmedix 的安全進入單元具有非侵入性特性,因此預計批准過程不會花費大量時間。預計大學將於 2023 年 3 月份開始認證程序。

"The Safe Entry Station powered by artificial intelligence is a highly effective and intelligent instrument for detecting health problems and modernizing medical examinations," commented Assoc. Prof. Ts. Dr. Zulkarnain Kedah.

Assoc 評論說:「由人工智能提供支持的安全入口站是一種高效和智能化的儀器,用於檢測健康問題並使醫療檢查現代化。」Ts 教授祖卡奈因·吉打醫生

"AI powered screening in a quick, non-invasive, no contact methodology is the way of the future. The Safe Entry Unit has been validated by our University with demonstrated high accuracy rates for multi functional application. We look forward to getting this approved as a medical device for Indonesia and assisting with commercial deployment", commented Professor Dr. Ir. Untung Rahardja, M.T.I., MM, President at the University of Raharja.

「以快速、非侵入性、無接觸的方法進行 AI 驅動的篩選是未來的方式。安全進入單元已通過我們的大學驗證,證明了多功能應用的高精度率。我們期待獲得批准為印尼的醫療設備並協助商業部署。」Ir.Untung Rahardja, M.T.I., MM, 總統在拉哈賈大學.

"With Indonesia being the fourth most populous country in the world housing over 280 million people and being a part of the ASEAN group of countries with over 680 million people and more than 10 trillion dollars in GDP - the market opportunity for Safe Entry is immense, not only in Indonensia but also throughout the Asean region. There's a strong demand for various medical devices in Indoensia, and the sheer size of the population positions Predictmedix to build a lucrative sales pipeline," commented Dr. Rahul Kushwah, Chief Operating Officer at Predictmedix. "The further validation of our technology from the University adds even more credibility to Safe Entry and the work we are accomplishing at Predictmedix."

「隨著印尼是全球第四大人口最多的國家,人口超過 2.8 億人,並且是東盟集團擁有超過 680 億人口和超過 10 萬億美元的國家的一部分-安全進入的市場機會是巨大的,不僅在印度尼西亞,而且在整個東盟地區。印度支那州對各種醫療器械的需求很強,以及預測媒體的人口數量龐大,以建立一個有利可圖的銷售管道。」「大學對我們技術的進一步驗證為安全進入以及我們在 Predictmedix 所完成的工作增加了更多的可信度。」

About Predictmedix Inc.
Predictmedix (CSE:PMED) (OTCQB:PMEDF) (FRA:3QP) is an emerging provider of rapid health screening and remote patient care solutions globally. The Company's Safe Entry Stations - powered by a proprietary artificial intelligence (AI) - use multispectral cameras to analyze physiological data patterns and predict a variety of health issues including infectious diseases such as COVID-19, impairment by drugs or alcohol, fatique or various mental illnesses. Predictmedix's proprietary remote patient care platform empowers medical professionals with a suite of AI-powered tools to improve patient health outcomes. To learn more, please visit our website at or follow us on Twitter, Instagram or LinkedIn.

關於預科技股份有限公司
康科技 (CSE: PMED) (OTCQB: PMEDF) 是全球快速健康檢查和遠端病人照護解決方案的新興供應商。該公司的安全進入站由專有的人工智能(AI)提供支持-使用多光譜攝像機來分析生理數據模式並預測各種健康問題,包括傳染病,例如 COVID-19,藥物或酒精損害,疲勞或各種精神疾病。Predictmedix 專有的遠端病患照護平台為醫療專業人員提供一套由 AI 驅動的工具,以改善患者健康狀況。要了解更多信息,請訪問我們的網站,或者在推特,Instagram 或領英上關注我們。

Public Relations Contact
For further media information or to set up an interview, please contact:
Nelson Hudes
Hudes Communications International
(905) 660 9155
Nelson@hudescommunications.com

公共關係聯絡
有關更多媒體信息或安排訪問,請聯繫:
纳尔逊·胡德斯
胡德斯通信國際
(905) 660 9155
Nelson@hudescommunications.com

Dr. Rahul Kushwah
(647) 889 6916

拉胡爾·庫什沃博士
(647) 889 6916

Caution Regarding Forward-Looking Information:
This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management's reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances. The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful. Additionally, there are known and unknown risk factors which could cause the Company's actual results, performance or achievements to be materially different from any Page 4 of 4 future results, performance or achievements expressed or implied by the forward-looking information contained herein, such as, but not limited to dependence on obtaining regulatory approvals; the ability to obtain intellectual property rights related to its technology; limited operating history; general business, economic, competitive, political, regulatory and social uncertainties, and in particular, uncertainties related to COVID-19; risks related to factors beyond the control of the Company, including risks related to COVID-19; risks related to the Company's shares, including price volatility due to events that may or may not be within such party's control; reliance on management; and the emergency of additional competitors in the industry.

關於前瞻性信息的注意事項:
此新聞稿可能包含前瞻性聲明和基於當前預期的信息。這些聲明不應被視為對本公司未來業績或業績的保證。該等陳述涉及已知及未知的風險、不明朗因素及其他可能導致實際結果、表現或成就與該等聲明所暗示的重大不同因素。雖然這些陳述是基於管理層的合理假設,但不能保證這些假設將被證明是正確的。我們不承擔任何責任更新或修改它們以反映新的事件或情況。公司的證券尚未根據美國《1933 年證券法》(經修訂後的「美國證券法」)或適用的國家證券法(「美國證券法」)或適用的國家證券法規提供或出售,或出售給美國人士或「美國人」的帳戶或利益,但不得向美國證券法規定的人士或「美國人」的帳戶或利益提供或出售,但不可註冊或不適用的註冊規定。本新聞稿不構成要約出售或徵求購買要約,也不得在美國或任何該要約、招攬或銷售屬於非法的司法管轄區銷售有關證券。此外,存在已知及未知的風險因素,可能導致本公司的實際業績、表現或成就與本文所載前瞻性資料所表示或暗示的第 4 頁實際業績、表現或成就與未來第 4 頁有重大差異,例如,但不限於取得監管批准;獲得與其技術相關的知識產權的能力;經營歷史有限,經營歷史,不限於依賴監管機構批准;具有獲得與其技術相關的知識產權的能力;有限的經營歷史,經營歷史,經濟明確性,不限於監管機構批准,以及特別是與 COVID-19 有關的不明朗因素;與本公司無法控制的因素有關的風險,包括與 COVID-19 相關的風險;與本公司股份有關的風險,包括由於該方可能或可能不可能受到控制的事件引起的價格波動;依賴管理;以及業內其他競爭對手的緊急情況。

All forward-looking information herein is qualified in its entirety by this cautionary statement, and the Company disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except required by law.

此處的所有前瞻性資訊均符合本警示性聲明的完整資料,除法律要求外,本公司不承擔任何修改或更新此等前瞻性資訊的義務,或公開宣佈本文所載任何前瞻性資訊的任何修訂結果,以反映未來的結果、事件或發展。

Disclaimer: "The Company is not making any express or implied claims that its product has the ability to diagnose, eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time."

免責聲明:「公司目前沒有對其產品有能力診斷,消除,治愈或抑制 COVID-19(或 SARS-2 冠狀病毒)的任何明示或暗示聲明。」

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

加拿大證券交易所沒有審查也不承擔此新聞稿的充分性或準確性的責任。

SOURCE: PredictMedix Inc.

來源: 預測科技股份有限公司


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