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

SHANGHAI, April 4, 2026 /PRNewswire/ -- From April 2 to 31, the Assembly Character Toys brand Blokees made its debut at the 2026 Thailand Toy Expo. Blokees unveiled its two major categories — Blokees Model Kits and Blokees Wheels, highlighting a diverse product matrix of more than 300 products across 17 globally recognized IPs, including Ultraman, Transformers, DC, Evangelion, Naruto, Minions, Jurassic World, Hatsune Miku, and Hero Infinity. Four new model kits also made their global debut, emerging as key highlights of the event.

Mario Maurer attended the opening ceremony of Blokees Thailand Toy Expo as a special guest and engaged in interactive exchanges with consumers.

In the Blokees Model Kits category, Blokees exhibited its Champion, Legend, and Fantastic Series, featuring popular IPs such as Transformers, DC, Mega Man, Saint Seiya, Evangelion, and Naruto. More than 50 products were presented to consumers. Among them, four newly launched items—including Blokees Saint Seiya-Champion Class-12-Phoenix Ikki, Blokees Saint Seiya-Champion Class-14-Andromeda Shun, Blokees DC-Champion Class 05-Batman (HUSH), and Blokees DC-Champion Class 06-Catwoman (Hush)—drew strong interest from fans.

Blokees also highlighted its HERO5 and HERO10 series, featuring well-known IPs including Transformers, Saint Seiya, and Naruto, catering to consumers of hero-themed collectible models.

The DaaLaMode series introduced a range of products inspired by popular IPs such as Hatsune Miku, appealing to female consumers. Meanwhile, the TERRAVENTURE series presented nature and creature-themed model kits based on Jurassic World, further expanding Blokees' offerings across different consumer segments.

In the Blokees Wheels category, which integrates construction, play, and customization, products are organized into the C, E, and S series. The lineup includes IP-based offerings from Transformers, Ultraman, and Batman, with upcoming collaborations featuring Fast & Furious and Ford.

In addition, Blokees highlighted its global consumer ecosystem, BFC (Blokees Family Creator). Selected works from 2025 The 3rd BFC Creation Contest Stellar Season were exhibited in Thailand for the first time, reflecting strong user creativity and engagement. 2026 The 4th BFC Creation Contest Season of Awakening has officially launched, further encouraging global participation.

Under its "Universally appealing, Stepwise pricing, Globally promoting" strategy, Blokees continues to expand across Southeast Asia, Europe, North America, and Latin America. Thailand is rapidly becoming a strategic hub in its regional expansion, as the company strengthens both product innovation and community-driven growth worldwide.

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

Blokees made its debut at 2026 Thailand Toy Expo, exhibiting multiple products