Movano Health (Nasdaq:MOVE) announced today that it received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring.

Movano Health（Nasdaq:MOVE）今天宣布，其EvieMED戒指中的脉搏血氧仪获得FDA 510（k）许可。

Clearance enables Movano to pursue new opportunities for health monitoring solutions needed for applications like clinical trials, post-clinical trial management and remote patient monitoring for both healthcare providers and payors, the company said in a news release.

公司在一份新闻稿中说，该许可使 Movano 能够为临床试验、临床试验后管理以及医疗服务提供商和支付方的远程患者监护等应用所需的健康监护解决方案寻求新的机遇。

Pleasanton, California-based Movano said it already began collaborating with potential partners in anticipation of FDA clearance. Its potential partners operate across the entire healthcare industry spectrum and the company expects more following the FDA nod. Movano is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025.

总部位于加利福尼亚州普莱森顿的莫瓦诺表示，它已经开始与潜在的合作伙伴合作，以期获得FDA的批准。它的潜在合作伙伴在整个医疗保健行业范围内运作，该公司预计在FDA批准后会有更多合作伙伴。莫瓦诺目前正与一家大型付款人达成协议，计划于2025年初对EvieMED Ring进行试点研究。

The study covers health management for high-risk populations..

这项研究涵盖了高危人群的健康管理。。

Additionally, Movano has discussions ongoing with a global pharmaceutical company and leading clinical research organization around using the EvieMED Ring in upcoming trials. An MIT study on long COVID and chronic Lyme disease also elected to use the EvieMED Ring.

此外，Movano正在与一家全球制药公司和领先的临床研究组织讨论在即将进行的试验中使用EvieMED环。麻省理工学院一项关于长型冠状病毒和慢性莱姆病的研究也选择使用EvieMED环。

EvieMED combines the accuracy of a medical device with the comfort of a continuous wearable, Movano says. It features a small gap in the ring surface and a slight flex to accommodate finger swelling. A pivotal study also found that the ring produces accurate readings among users with darker skin tones..

Movano说，EvieMED将医疗设备的准确性与持续佩戴的舒适性相结合。它的特点是戒指表面有一个小间隙，并有轻微的弯曲以适应手指肿胀。一项关键性研究还发现，该戒指可以在肤色较深的用户中产生准确的读数。。

Additionally, the EvieMED Ring collects a range of wellness metrics. Those include sleep, activity, temperature variability, calories burned and respiration rate.

此外，EvieMED戒指还收集了一系列健康指标。这些因素包括睡眠、活动、温度变化、燃烧的卡路里和呼吸频率。

“We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B channels,” said John Mastrototaro, president and CEO of Movano Health. “This FDA 510(k) clearance marks a major milestone for the company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles..

Movano Health总裁兼首席执行官约翰·马斯特罗托塔罗（JohnMastrototaro）表示：“我们在消费者可穿戴市场推出了Evie戒指，但我们更广泛的目标一直是为B2B渠道提供临床级设备。”。“这项FDA 510（k）许可标志着该公司的一个重要里程碑，并将我们的业务范围扩大到制药公司、医疗器械制造商和付款人，以寻求更准确、一致和舒适的健康监测解决方案，通过轻松融入患者的生活方式来帮助提高依从性。。

“This milestone marks the beginning of our plans to accelerate distribution of EvieMED. With the significant foundational work in achieving our first clearance now behind us, we are eager to continue to collaborate with the FDA on securing additional clearances including respiration rate and other critical analytes and diagnoses.

“这一里程碑标志着我们加快EvieMED分发计划的开始。随着我们在实现首次许可方面的重要基础工作已经完成，我们渴望继续与FDA合作，以确保获得额外的许可，包括呼吸频率和其他关键分析物和诊断。

We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring.”.

我们也对利用我们专有的射频（RF）技术解决无袖带血压和无创血糖监测的机会感到兴奋。”。