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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 宣布完成印尼医疗器械监管部门批准的 1600 人临床研究
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
  • 在印度尼西亚雅加达一所著名大学进行的这项有1600人参加的研究为Predicmedix被列为 “医疗器械” 的安全入境做好了准备,以获得监管部门的批准
  • 医疗器械分类使Predicmedix能够在印度尼西亚大规模商业化安全入境
  • 第三方临床验证是Predicmedix的人工智能筛查技术的又一个里程碑

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.

安大略省多伦多/ACCESSWIRE/2023 年 3 月 8 日/ 由专有人工智能(AI)提供支持的快速健康筛查解决方案的新兴提供商Predictmedix Inc.(“Predicmedix” 或 “公司”)(CSE: PMED)(OTCQB: PMEDF)(FRA: 3QP)今天宣布,完成了一项在印度尼西亚一所著名大学进行的1600人的临床研究,该研究旨在验证该公司的人工智能驱动的非侵入性筛查技术为将安全入境归类为医疗器械的监管批准申请做准备。

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.

随着该公司在印度尼西亚的商业化努力正在进行中,将Safe Entry归类为医疗器械是扩展到印度尼西亚市场格局不可或缺的一步。该公司人工智能驱动的筛查技术的第三方验证标志着Safe Entry有效性的又一个里程碑。

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.

印度尼西亚卫生部(MoH)下属的国家药物和食品控制局(NADFC)对医疗器械进行监管。该组织在海外的所有上市前和上市后评估、标准化、立法和良好生产规范 (GMP) 认证。所有医疗器械和体外诊断产品(In Vitro Diagnostics)在进口前必须获得卫生部颁发给当地许可分销商的注册号和产品许可证。由于Predictmedix的安全入口单元具有非侵入性质,因此批准过程预计不会花费大量时间。该大学预计将在2023年3月内开始认证程序。

"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.

阿索克评论说:“由人工智能提供支持的安全进入站是一种用于检测健康问题和实现医学检查现代化的高效智能仪器。”Ts 教授Zulkarnain Kedah 博士。

"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、无接触的方法进行人工智能驱动的筛查是未来的发展方向。安全进入装置已通过我们大学的验证,在多功能应用中表现出很高的准确率。我们期待将其批准为印度尼西亚的医疗器械,并协助进行商业部署。” Ir教授评论道。Untung Rahardja,M.T.I.,MM,拉哈贾大学校长。

"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."

“印度尼西亚是世界上人口第四多的国家,拥有超过2.8亿人口,也是拥有超过6.8亿人口和超过10万亿GDP的东盟国家集团的一部分,因此安全入境的市场机会是巨大的,不仅在印度尼西亚,而且在整个东盟地区。印度尼西亚对各种医疗器械的需求强劲,庞大的人口使Predictmedix得以建立利润丰厚的销售渠道。” Predictmedix首席运营官Rahul Kushwah博士评论道。“大学对我们技术的进一步验证提高了Safe Entry以及我们在Predictmedix所完成的工作的可信度。”

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.

关于 Predicmedix Inc.
Predictmedix(CSE: PMED)(OTCQB: PMEDF)(FRA: 3QP)是全球快速健康筛查和远程患者护理解决方案的新兴提供商。该公司的安全进入站由专有的人工智能(AI)提供支持,使用多光谱摄像机分析生理数据模式并预测各种健康问题,包括 COVID-19 等传染病、药物或酒精损伤、疲劳或各种精神疾病。Predictmedix 专有的远程患者护理平台为医疗专业人员提供了一套人工智能驱动的工具,以改善患者的健康状况。要了解更多信息,请访问我们的网站或在推特、Instagram 或 LinkedIn 上关注我们。

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

公共关系联系人
欲了解更多媒体信息或安排采访,请联系:
纳尔逊·哈德斯
Hudes 通讯国际
(905) 660 9155
Nelson@hudescommunications.com

Dr. Rahul Kushwah
(647) 889 6916

拉胡尔·库什瓦博士
(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.

关于前瞻性信息的注意事项:
本新闻稿可能包含前瞻性陈述和基于当前预期的信息。这些陈述不应被视为对公司未来业绩或业绩的保证。此类陈述涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致实际业绩、业绩或成就与此类陈述所暗示的结果存在重大差异。尽管此类陈述基于管理层的合理假设,但无法保证此类假设会被证明是正确的。我们不负责更新或修改它们以反映新的事件或情况。公司的证券尚未根据经修订的1933年《美国证券法》(“美国证券法”)或适用的州证券法进行注册,如果没有注册或不受此类注册要求的适用豁免,则不得向在美国的人或 “美国个人”(该术语的定义见美国证券法的法规)发行或出售,也不得为他们的账户或利益发行或出售。本新闻稿不构成出售要约或招揽买入要约,也不得在美国或任何此类要约、招揽或出售非法的司法管辖区出售证券。此外,还有一些已知和未知的风险因素可能导致公司的实际业绩、业绩或成就与本文件所含前瞻性信息所表达或暗示的未来业绩、业绩或成就存在重大差异,例如但不限于依赖获得监管部门批准;获得与其技术相关的知识产权的能力;运营历史有限;一般商业、经济、竞争、政治、监管和社会不确定性,以及特别是与 COVID-19 相关的不确定性;与公司无法控制的因素相关的风险,包括与 COVID-19 相关的风险;与公司股票相关的风险,包括该方可能也可能无法控制的事件导致的价格波动;对管理层的依赖;以及该行业其他竞争对手的紧急情况。

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.

本文中的所有前瞻性信息均受本警示声明的全面限制,除非法律要求,否则公司不承担任何修改或更新任何此类前瞻性信息或公开宣布为反映未来业绩、事件或发展而对本文包含的任何前瞻性信息进行任何修订的结果的义务。

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."

免责声明:“公司目前没有明示或暗示地声称其产品能够诊断、消除、治愈或控制 COVID-19(或 SARS-2 冠状病毒)。”

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

加拿大证券交易所尚未审查本新闻稿的充分性或准确性,也不承担任何责任。

SOURCE: PredictMedix Inc.

来源: predicmedix Inc.


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