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

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

Business

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

2025-05-01 23:06 Last Updated At:23:25

  • 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

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

ANSHUN, China, May 23, 2026 /PRNewswire/ -- On May 21, at the Guizhou Anshun Tourism Development Conference, Mafengwo Travel Group officially launched three flagship "New Mountain Play" benchmark projects — Huangheying Water Cave, Lotus Ancient Cave, and Luoyang Glasswater Gorge — while jointly releasing the 2026 Anshun Mountain Outdoor New Play Playbook with the Anshun Municipal Bureau of Culture, Sports, Radio, TV and Tourism. By redefining mountain outdoor travel experiences through "new play," the initiative injects fresh momentum into Anshun's positioning as an international mountain tourism destination. 

"Personalized travel is rising rapidly. Tourism is transitioning from a 'sightseeing economy' to an 'experience economy.' More than just 'having been there,' travelers today seek emotional value from scenic spots and related projects," said Chen Gang, Founder and CEO of Mafengwo, in a speech titled *Co-creating the Super Play Era of Mountain Tourism*. He noted that leveraging benchmark new-play projects such as Huangheying Water Cave, Lotus Ancient Cave, and Luoyang Glasswater Gorge, Mafengwo will work with Anshun to integrate "new play, new formats, new marketing, and new consumption" into a holistic innovation ecosystem for destination-wide play. Together, they aim to revitalize natural resources, energize industrial momentum, link rural revitalization, and jointly build Anshun into a national hub for new mountain play.

At a time when travelers are increasingly weary of "man-made check-in spots" and homogenized internet-famous projects, the newly launched projects abandon the old path of large-scale construction. Instead, they return to the wild itself, adopting a "light development, heavy experience" approach to create mountain plays that are "wild on the outside, refined on the inside." Huangheying Water Cave focuses on "natural wonders + interactive adventure," using its original "water-cave" karst features to create a genuine sense of "underground exploration." Lotus Ancient Cave, based on a massive natural cave, integrates "light ultimate" activities such as via ferrata, rappelling, and cave drop towers, allowing ordinary visitors to feel adrenaline-pumping "heart-racing moments" in a natural setting. Luoyang Glasswater Gorge follows the original river course, using natural elevation differences to design trails for hiking, canyoning, and waterfall rappelling, with minimal artificial construction, emphasizing the pristine "glass water" and an eco-harmonious, back-to-nature mountain experience.

At the "2026 Anshun Mountain Tourism New Play" sharing session, Mafengwo Travel Group and the Anshun Municipal Bureau of Culture, Sports, Radio, TV and Tourism jointly released the *2026 Anshun Mountain Outdoor New Play Playbook*. Ten selected plays in non-traditional mountain settings were featured, including "Night Tour of Dupo Tang — Immersive Journey into the World of Journey to the West," "Watch Intangible Cultural Heritage 'Spider-Man' Climb Cliffs for Bird's Nests," and "370-Meter Free Fall at Balinghe Bridge." These showcase how Anshun creatively uses its karst landscapes as a natural "amusement park" for mountain experiences.

He Weihong, Vice Mayor of Anshun, stated in his address: "In Anshun, the 'City of 21°C,' mountains are no longer just scenery to be viewed. They are living fields to be climbed, immersed in, jumped over, and breathed in. Anshun will take this conference as an opportunity to accelerate the internationalization of its mountain tourism and build a first-class mountain outdoor sports destination." During the event, Anshun Tourism Group also promoted its mountain outdoor travel routes.

By early 2026, the number of outdoor sports participants in China had exceeded 400 million, with participation in mountain hiking, trail running, rock climbing, and canyoning rising year by year. Driven by the dual trends of "nationwide fitness" and "pan-outdoor" activities, mountain play is moving from niche circles to the general public. Unlike the high barriers of traditional outdoor activities, Anshun's new plays target the blue ocean market of "light ultimate + strong experience + high shareability." Whether it's a "bridge bungee jump," checking out the natural wonder "Eye of the Great Sage," or experiencing a "Journey to the West fantasy" at night by Dupo Tang Waterfall — these activities are novel, beginner-friendly, and serve as natural content and social currency.

Anshun's mountain play innovation has also attracted international attention. Anouar, Chief Representative of the Tunisian National Tourism Office in China, noted in his speech that Anshun's innovation in integrating mountain tourism and sports is worth learning from for many international peers. He noted that Tunisia has diverse mountain resources across the country, with history embedded in the mountains and culture in the scenery — this is the unique charm of Tunisia's mountains. He looks forward to China-Tunisia cooperation to explore more mountain tourism opportunities and co-create new partnership models.

An international dialogue session brought together representatives from the Norwegian National Tourist Board, Visit Flanders (Belgium), and the Saudi Tourism Authority to discuss mountain outdoor tourism upgrade from a global perspective. The guests agreed that they were delighted to see that Anshun is not simply replicating a "Switzerland of the East" but is creating an entirely new "universal language of mountain tourism." The internationalization of mountain tourism is not about imitation but about excavating the unique narratives of local landscapes — with its green mountains and clear waters as the canvas and play innovation as the brush, Anshun is painting a vibrant new picture for the world.

A domestic dialogue session brought together frontier explorers, practitioners, and experts in mountain sports tourism to discuss the future development of mountain sports tourism from the perspectives of communities, products, and operations. Qin Chuan, Founder of Wanan Youth Travel, noted that with technological advancements and equipment iteration, more and more "outdoor novices" without professional training can enjoy the pleasures of the wild. Currently, Wanan Youth Travel is selecting and developing "super single products" and continuously improving service quality to deliver ultimate outdoor experiences to visitors.

After the conference, industry guests conducted on-site inspections of new play projects, including Lotus Ancient Cave, Dupo Tang Night Tour, Anshun Ancient Town, and Getu River. Wang Yu, Chief Representative of the Norwegian National Tourist Board in Greater China, remarked: "Anshun and Norway share many similarities. Anshun's new mountain plays emphasize 'light development, heavy experience.' Take Lotus Ancient Cave — it doesn't feel like a 'designed' scenic spot, but rather an extension of Anshun's natural mountain charm itself, an experiential field you can fully immerse yourself in. The scale of this 'light ultimate' experience is just right — thrilling enough, yet truly authentic."

** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

Light Ultimate, High Experience, Original Ecology, Personalization -- Mafengwo and Anshun Municipal Bureau of Culture, Sports, Radio, TV and Tourism Co-create New Forms of Mountain Tourism

Light Ultimate, High Experience, Original Ecology, Personalization -- Mafengwo and Anshun Municipal Bureau of Culture, Sports, Radio, TV and Tourism Co-create New Forms of Mountain Tourism

Light Ultimate, High Experience, Original Ecology, Personalization -- Mafengwo and Anshun Municipal Bureau of Culture, Sports, Radio, TV and Tourism Co-create New Forms of Mountain Tourism

Light Ultimate, High Experience, Original Ecology, Personalization -- Mafengwo and Anshun Municipal Bureau of Culture, Sports, Radio, TV and Tourism Co-create New Forms of Mountain Tourism

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