FaceHeart Received Another FDA Clearance for its Contactless Video-Based Vital Sign Measurement of Respiratory Rate

• Developed by FaceHeart, FH Vitals SDK-RR has obtained FDA Clearance. This is the second 510(k) class II SaMD (Software as a Medical Device) FaceHeart received from the FDA.
• FaceHeart Vitalsâ„¢ is a video-based, contactless vital sign measurement SDK that can be integrated into devices such as smartphones seamlessly, providing heart rate, respiration rate, blood pressure and other vital sign readings in 50 seconds.

TAIPEI, May 1, 2025 /PRNewswire/ -- FaceHeart Corporation (FaceHeart), an AI health tech company, has received another FDA 510(k) clearance for FaceHeart Vitalsâ„¢, its contactless video-based vital sign solution.

On top of heart rate measurement, FDA granted 510(k) clearance (k243966) to FaceHeart Vitalsâ„¢ (registered as FH Vitals SDK-RR) as a Class II SaMD (Software as a Medical Device) for respiratory rate measurement on April 9th, 2025. The respiratory rate measurements derived from the FH Vitals SDK-RR demonstrated deviations consistently within ±2 breaths per minute (bpm) across all devices.

FaceHeart Vitals™ is the first FDA-cleared software development kit (SDK) solution that enables contactless video-based vital sign measurement—including heart rate (HR), respiratory rate (RR), blood pressure (BP), oxygen saturation (SpO2), and heart rate variability (HRV)—via a facial scan on built-in camera of smartphones within 50 seconds. It leverages the remote photoplethysmography (rPPG) technology that extracts subtle color changes of the facial skin. In addition, by conducting the analysis via edge computing without cloud service eliminates network latency and addresses security concerns at the same time.

Receiving FDA clearance not only represents the recognition of FaceHeart's undivided attention to clinical trials, but also reinforces its commitment to deliver accessible and reliable contactless vital sign measurement to the general public. Designed with the capability to be seamlessly integrated into common edge devices such as smartphones (iOS/Android), tablets, laptops/desktops (Windows) etc., FaceHeart Vitalsâ„¢ empowers preventive health, telemedicine, elderly care, and chronic disease management with real-time, user-friendly and accurate contactless vital sign measurement, transforming readily available devices into medical-grade solutions instantly.

"Following the first FDA Clearance on heart rate in 2023, this FDA clearance on respiratory rate marks a milestone and commitment of FaceHeart in providing the healthcare industry with the most reliable contactless vital sign measurement solution," said Dr. Meng Liang Chung, Co-founder and Vice President of FaceHeart Corporation. "As demands for more personalized and effective healthcare solutions arise globally, FaceHeart's contactless vital sign measurement solution undoubtedly plays a pivotal role in proactive and preventive healthcare-related services—helping people live not just longer, but healthier lives within reach."

About FaceHeart

FaceHeart Corporation (https://faceheart.com/) is a leading health technology company that improves human health with its expertise in artificial intelligence, computer vision, and deep learning. Through FaceHeart's technology, individuals can access high-quality health measurements with a simple 50-second facial scan.

Contacts

Please email marketing@faceheart.com for media, sales or other inquiries.

TAIPEI, May 1, 2025 /PRNewswire/ -- FaceHeart Corporation (FaceHeart), an AI health tech company, has received another FDA 510(k) clearance for FaceHeart Vitalsâ„¢, its contactless video-based vital sign solution.

On top of heart rate measurement, FDA granted 510(k) clearance (k243966) to FaceHeart Vitalsâ„¢ (registered as FH Vitals SDK-RR) as a Class II SaMD (Software as a Medical Device) for respiratory rate measurement on April 9th, 2025. The respiratory rate measurements derived from the FH Vitals SDK-RR demonstrated deviations consistently within ±2 breaths per minute (bpm) across all devices.

FaceHeart Vitals™ is the first FDA-cleared software development kit (SDK) solution that enables contactless video-based vital sign measurement—including heart rate (HR), respiratory rate (RR), blood pressure (BP), oxygen saturation (SpO2), and heart rate variability (HRV)—via a facial scan on built-in camera of smartphones within 50 seconds. It leverages the remote photoplethysmography (rPPG) technology that extracts subtle color changes of the facial skin. In addition, by conducting the analysis via edge computing without cloud service eliminates network latency and addresses security concerns at the same time.

Receiving FDA clearance not only represents the recognition of FaceHeart's undivided attention to clinical trials, but also reinforces its commitment to deliver accessible and reliable contactless vital sign measurement to the general public. Designed with the capability to be seamlessly integrated into common edge devices such as smartphones (iOS/Android), tablets, laptops/desktops (Windows) etc., FaceHeart Vitalsâ„¢ empowers preventive health, telemedicine, elderly care, and chronic disease management with real-time, user-friendly and accurate contactless vital sign measurement, transforming readily available devices into medical-grade solutions instantly.

"Following the first FDA Clearance on heart rate in 2023, this FDA clearance on respiratory rate marks a milestone and commitment of FaceHeart in providing the healthcare industry with the most reliable contactless vital sign measurement solution," said Dr. Meng Liang Chung, Co-founder and Vice President of FaceHeart Corporation. "As demands for more personalized and effective healthcare solutions arise globally, FaceHeart's contactless vital sign measurement solution undoubtedly plays a pivotal role in proactive and preventive healthcare-related services—helping people live not just longer, but healthier lives within reach."

About FaceHeart

FaceHeart Corporation (https://faceheart.com/) is a leading health technology company that improves human health with its expertise in artificial intelligence, computer vision, and deep learning. Through FaceHeart's technology, individuals can access high-quality health measurements with a simple 50-second facial scan.

Contacts

Please email marketing@faceheart.com for media, sales or other inquiries.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

FaceHeart Received Another FDA Clearance for its Contactless Video-Based Vital Sign Measurement of Respiratory Rate

TAIPEI, Dec. 31, 2025 /PRNewswire/ -- ARTERY Technology (Cayman) Corporation (Stock Code: 6907; hereinafter referred to as "ARTERY-KY"), a leading designer of 32-bit microcontrollers (MCUs), is scheduled to be listed on the Taipei Exchange (TPEx) under the Semiconductor Industry category in January 2026. The Company held its first pre-IPO investor conference on December 30 (Tuesday) at the Grand Hyatt Taipei, where it presented its competitive strengths and future business outlook to investors.

As a subsidiary of Faraday Technology, ARTERY-KY focuses on the development of high-end 32-bit MCUs. Leveraging ARM® Cortex®-M4 cores with an industry-leading maximum clock speed of up to 288 MHz, the Company delivers exceptional performance. In addition to successfully entering the supply chains of leading global brands, ARTERY-KY has established itself as a key contributor in the China market through localized technical advantages, serving as an important partner in regional supply chain transformation.

ARTERY-KY possesses comprehensive technical capabilities spanning core architecture design to application integration. Its end-market applications cover a wide range of fields, including industrial and motor control, consumer electronics, commercial applications, and vertical industries such as medical, IoT, communications, and automotive electronics. With strengths in high performance, low power consumption, superior integration, and high cost-effectiveness, the Company continues to expand into emerging applications such as drones, robotics, and edge AI, demonstrating strong market competitiveness and growth momentum.

In terms of financial performance, ARTERY-KY recorded revenue of NT$1.635 billion in 2024, representing a year-on-year increase of over 60%, with earnings per share (EPS) of NT$1.67. Revenue for the first three quarters of 2025 reached NT$1.234 billion, maintaining a high level and setting a new historical high for the same period, indicating that the Company has emerged from the inventory adjustment cycle. With continued optimization of its product mix, gross margin rebounded significantly to 33.84%. Net profit after tax for the first three quarters totaled NT$70.52 million, with basic EPS of NT$1.38, marking a 56% year-on-year increase and reflecting solid profitability. As multiple new application projects enter mass production and major customer orders continue to grow steadily, the market expects further optimization of the product portfolio in 2026, driving simultaneous growth in revenue and earnings.

Looking ahead, ARTERY-KY has outlined three major growth strategies. First, it will establish a comprehensive MCU foundation spanning M0 to M85 to build a highly compatible ecosystem. Second, it will expand its ASIC-based customized MCU services to help customers rapidly develop application-specific chips. Finally, the Company will aggressively pursue edge AI opportunities by collaborating with UMC and Faraday Technology, utilizing the most advanced 28-nanometer embedded Flash process to develop an intelligent inference platform. Through a strategy focused on breadth, depth, and forward-looking innovation, ARTERY-KY aims to fully activate its semiconductor growth engine.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Emerging MCU Force ARTERY-KY to Be Listed on TPEx in January 2026, Driving High-Performance Growth Through MCU, Customization, and Edge AI