Health Gauge Initiates FDA Approval Process
AI/ML Innovations Inc., a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its subsidiary, Health Gauge, has secured key strategic partnerships to help ensure that it scales its market opportunities and enhances its ability to effectively satisfy growing product demand. Specifically, these partnerships are intended to assist Health Gauge in addressing FDA requirements for entry into the US marketplace, as well as implementation of the most stringent of data management privacy and security standards, as Health Gauge looks towards international expansion.
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“Health Gauge views the entry into the US health and wellness space as a logical and critical near-term milestone” said Tim Daniels, Executive Chairman of AI/ML. “In order to garner requisite approvals and the utmost of confidence in Health Gauge’s portfolio of products and services by retail users, channel partners, enterprise level clients and governmental regulators, Health Gauge is utilizing the resources of industry leading partners who have the expertise to help ensure that we expeditiously and effectively meet and exceed the highest of industry standards.”
Health Gauge is working closely with Zi Medical to ensure it is addressing core regulatory requirements for entry into the US and Canadian markets initially, to be followed by other global markets of strategic importance to Health Gauge. Zi Medical is a Registered U.S. FDA Agent who provides services globally to medical device, IVD and pharma companies in the areas of regulatory submissions and filings, strategy, international product registration and licenses, regulatory training and support, and quality compliance. The primary regions they cover include the USA, the EU, China, Taiwan, Hong Kong, Singapore, Japan, Korea, Malaysia, Philippines, Singapore, Indonesia, India, Thailand, Vietnam, New Zealand, Australia, Mexico, Argentina, and Brazil.
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Health Gauge is deploying its core architecture with MedStack to ensure the highest level of compliance to privacy and security protection of Health Gauge’s client data. MedStack empowers healthcare enterprises and health solution providers to onboard digital innovations faster, by helping companies meet privacy, and security expectations up front, by way of standardization of architecture and regulation-mapped policies.
Privacy Horizon’s Virtual Privacy and Security Office is equipping Health Gauge with the policy frameworks and capabilities necessary to safeguard the privacy rights of individuals and protect personal information from loss or theft, unauthorized access, modification, copying, collection, use, unauthorized disclosure or retention.
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