FaceHeart seeks FDA clearance for image-based vital sign measurement technology to capitalize on telemedicine opportunities

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Jerry Chang, President of FaceHeart

Following the rapid spread of the COVID-19 pandemic since 2020, which has posed a serious challenge to medical facilities worldwide, governments have come to realize how precious medical capacities are. As such, the policy focus of government agencies and medical institutions has to gradually incorporate mechanisms that reflecting patient risk levels as to optimize limited medical resources. FaceHeart's image-based vital sign measurement technology has the potential in becoming part of a home healthcare system that facilitates the efficiency of medical resource allocation in society due to its ease of use and high accuracy. As a result, FaceHeart's technology has recently gained the attention of the medical industry. According to Jerry Chang, president of FaceHeart, the company has submitted a clinical trial application to the FDA in 2022. If the process goes smoothly, the company will receive certifications between 2023 and 2025 for vital signs measurements. It would be able to capitalize on ample business opportunities arising from the new era of medical care.

FaceHeart's image-based vital sign measurement technology can measure heart rate, blood pressure, blood oxygen, respiration, and other physiological data of a patient in a home environment by simply using a camera on a smartphone or tablet that captures the patient's face. Wearable devices such as smartwatches or wristbands used for an extended period of time or medical measurement equipment operated by professionals with the help of a third party are therefore, not required. Furthermore, all of this can be done with an accuracy that meets medical standards. Therefore, the technology is well suited for telemedicine applications. Jerry Chang pointed out that image-based vital sign measurement devices can be set up easily, accurately and quickly at home to capture patients' vital signs. In tomorrow's medical system, such devices could be used by patients with chronic diseases—they are able to recover at home if their physiological data is normal, or visit the hospital if the data is abnormal as directed by a physician, thereby optimizing the allocation of healthcare resources.

In addition to appropriate allocation of healthcare resources, FaceHeart's image-based vital sign measurement technology has the potential to be included in the Medicare coverage. Jerry Chang explained that as part of the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services updated its Medicare coverage guidelines in 2018 to include certain remote patient monitoring (RPM) services in the list of insurance benefits. FaceHeart's image-based vital sign measurement technology can be used for RPM covered by Medicare. For example, the technology can continuously measure and record patients' vital signs during various treatments, which is helpful to medical facilities in collecting relevant data and facilitating the operation of subsequent medical insurance mechanism. FaceHeart could benefit from becoming a Medicare device provider in two ways.

First, the company would see an increased volume of sales, and second, insurance carriers would be made liable to process payment for the products, solving subsequent cash flow issues.

FaceHeart's technology attracts attention of medical community for ease of use and high accuracy

The main reason for industry interest in FaceHeart's image-based vital sign measurement technology is its ease of use and high accuracy. These two key features are, in turn, a product of the company's professional team and years of clinical trials.

Jerry Chang also pointed out that the team members serving as the backbone of FaceHeart have all been students or graduates of the College of Electrical and Computer Engineering of National Yang Ming Chiao Tung University, excelling in digital signal processor (DSP) technology. As a result, the team is able to eliminate noise interferences, which are common when using DSP, and elevate the accuracy of consumer electronics, such as smartphones and tablets, to that of medical devices. FaceHeart's team is also supported by two heavyweight consultants: Dr. Jui-Sheng Sun, superintendent of the Trauma and Emergency Center of the China Medical University Hospital, and Dr. Gau-Jun Tang, superintendent of the National Yang Ming Chiao Tung University Hospital. Together, they ensure that FaceHeart's technology meets the needs of the medical industry.

To bolster IRB's and clinical trials, FaceHeart has also collaborated with National Taiwan University Hospital, Taipei Veterans General Hospital, Taipei Chang Gung Memorial Hospital, and En Chu Kong Hospital. Collecting more than 100 million medical records, the company used this huge amount of data to create a highly accurate measurement system based on the AI algorithm developed by FaceHeart's team.

Currently, FaceHeart is looking to expand its global market presence. In 2022, the company applied to the FDA for a review of its technologies that measure vital signs, such as heart rate, blood pressure, blood oxygen, and respiration. For each technology that passes the review, a device that measures the corresponding vital sign will be made commercially available. In the future, the company plans to apply for two additional important certifications: CE in the EU and HSA in Singapore, which will allow the company to export its technology overseas. In this regard, Jerry Chang is deeply appreciative of the policy support from the Ministry of Economic Affairs and the National Science and Technology Council. In particular, after participating in the Value Creation Program, FaceHeart was able to take part in technology fairs such as CES in the U.S. and VivaTech in France with the help of Taiwan Tech Arena (TTA). Jerry Chang also pointed out that FaceHeart has focused on overseas markets from the beginning. However, as a startup company, its resources are limited. Therefore, participating in these two major trade shows not only allowed the world to see FaceHeart and made its technology more visible, but also gave exposure to the team members. They are able to gain an understanding on market trends, as well as competitors' products. In addition, FaceHeart used the opportunity to develop various business models and explore further application opportunities. As a result, FaceHeart is able to improve the competitiveness of its products and take advantage of business opportunities in smart medicine in the post-pandemic era.