Multiple 'First-of-its-Kind' Prescription-Grade Wearables Emerge as the Sector Advances Toward Therapeutic Intervention

On July 1, the FDA approved the first AI-powered wearable device for the treatment of essential tremor, offering a new personalized solution for this refractory condition. Encouragingly, this is not an isolated case but rather a microcosm of the continuous innovations and breakthroughs seen recently in the wearable device sector.

In recent years, an increasing number of AI-enabled wearable devices have begun to offer innovative solutions, gradually evolving from mere monitoring toward “prescription-grade” therapeutic interventions.

The Path for Wearables Is Widening.

The Felix NeuroAI wristband, approved by the FDA, was developed by the startup Fasikl. Spun out of the University of Minnesota in the United States, the company has completed two modest rounds of financing since its establishment in 2019, in 2023 and 2024 respectively.

Felix NeuroAI Wristband (Image from Fasikl's official website)

The Felix NeuroAI wristband, developed by the company, utilizes built-in sensors to monitor patients’ tremor signals in real time. By connecting to cloud-based AI algorithms that analyze tremor patterns, it triggers personalized neuromodulation to disrupt abnormal neural impulse conduction, thereby alleviating tremor symptoms.

Essential tremor is a neurological disorder characterized primarily by involuntary tremors of the hands, head, or other parts of the body, which worsen during the execution of fine motor tasks. According to the “Guidelines for the Diagnosis and Treatment of Essential Tremor in China (2020),” the prevalence of essential tremor in the general population is approximately 0.9%, while it reaches 4.6% among individuals aged 65 years and older in China. Based on these estimates, there are approximately 10 million patients with essential tremor in China.

Primary treatments for essential tremor include pharmacotherapy and surgical intervention, both of which have significant limitations. While medications can alleviate symptoms, their efficacy is often inconsistent and frequently accompanied by adverse effects. Surgical interventions such as deep brain stimulation (DBS), although effective to some extent, carry high surgical risks and are not suitable for all patients.

The Felix NeuroAI wristband provides round-the-clock symptom relief for patients, demonstrating efficacy across mild, moderate, and severe tremor cases. It can be used as a monotherapy or in combination with medication, offering a more flexible and comprehensive treatment regimen. This provides patients with a safer, more effective, convenient, and better-tolerated alternative.

In April this year, Fasikl announced its clinical trial data. An international, multicenter, randomized, double-blind, sham-controlled clinical trial involving 125 patients from China and the United States demonstrated that patients in the treatment group showed significant superiority over the placebo group in terms of the primary endpoint and multiple secondary endpoints. Furthermore, the therapeutic effect remained stable over a 90-day period, unaffected by patient age, gender, severity of tremor, or concomitant medication use.

At the American Academy of Neurology (AAN) Annual Meeting held that month, these findings were presented as “Breakthrough Science,” laying a solid foundation for FDA approval in July.

Prior to the launch of Felix NeuroAI, Cala Health introduced the Cala Trio wristband for the treatment of essential tremor in late 2021. The device was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) and received marketing authorization through the De Novo pathway, which is equivalent to that for innovative medical devices. Subsequently, Cala Health launched an upgraded product, the Cala kIQ, in 2022 and iterated it to its second generation last year. However, none of these products incorporated artificial intelligence (AI) capabilities.

This is merely another breakthrough achieved by wearable devices in the therapeutic field recently.

In the relatively less prominent field of otolaryngology, SoundHealth has also made continuous progress over the past two months, completing the strategic rollout of its SONU Band headband—from software features (selfie-based scanning) to expanded indications (now approved for use in children aged 12 and older). This innovative wearable device previously became the first FDA-approved wearable for the non-invasive treatment of moderate-to-severe nasal congestion via the De Novo pathway, and it was officially cleared for market launch in April this year.

Working Principle of the SONU Band Headband (Screenshot from SoundHealth Official Website)

Patients can use their smartphones to take selfies of their faces. AI algorithms will create a digital map of the sinuses based on these images and calculate the optimal sound wave vibration frequency. After wearing a wearable headband, the device will generate sound waves to gently vibrate the nasal cavity according to this data. This process helps constrict nasal capillaries, reduce nasal swelling, open up the nasal passages, and drain accumulated mucus, thereby relieving nasal congestion symptoms within 15 minutes.

Clinical trials have demonstrated that this innovative therapy acts rapidly, proving equivalent or superior to leading intranasal corticosteroid sprays in alleviating symptoms of allergy, inflammation, and congestion, with over 80% of patients reporting improvement in their nasal symptoms.

Even more encouraging is the immense potential demonstrated by wearable devices in the field of advanced-stage cancer.

Novocure’s wearable device Optune Lua, indicated for the treatment of metastatic non-small cell lung cancer (NSCLC), received FDA and CE approvals within six months. This innovative device utilizes Tumor Treating Fields (TTFields) to disrupt cancer cell viability. Phase 3 clinical trial results demonstrated that combining Optune Lua with PD-1/PD-L1 inhibitors or docetaxel significantly prolonged overall survival compared to using PD-1/PD-L1 inhibitors or docetaxel alone. Representing an innovative and urgently needed therapeutic option for metastatic NSCLC, this approach has the potential to transform the treatment landscape for advanced lung cancer.

The trend toward “prescription-grade” therapeutic interventions in wearables has become quite evident.

In European and American countries, wearable devices are also being placed under high expectations by governments and are being prioritized as a key component of health infrastructure.

In June, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. announced a policy proposal during a congressional hearing, seeking to have the federal government lead the implementation of the largest-ever marketing incentive campaign over the next four years to encourage every American citizen to wear wearable health devices.

The UK’s NHS has recently unveiled an ambitious ten-year health plan, which will bring about unprecedented digital transformation to the British healthcare system. Wearable technology is regarded as one of the five key transformative technologies.

The NHS stated in its Ten-Year Health Plan that by 2035, wearable devices will become standard equipment for prevention, chronic disease management, and post-acute care services within the National Health Service. This initiative will be implemented first in cardiovascular care, with plans to make remote monitoring of cardiovascular conditions via wearable devices a standard component of NHS care by 2028.

The NHS has also committed to making wearable devices a standard component of routine healthcare. This will be achieved by launching real-world assessment trials for wearables in collaboration with enterprises, co-developing next-generation wearable technologies, and even adopting the bold approach of providing devices free of charge in areas with the greatest health needs and high levels of poverty, thereby ensuring that all NHS patients have access to wearable technology.

In contrast, China currently lacks similar policy planning.

Historically, wearable devices have primarily focused on monitoring functions. From heart rate to ECG, and from blood oxygen to blood pressure, wearables are now capable of continuously monitoring vital signs with medical-grade accuracy—signals that play a key role in disease diagnosis and treatment. Currently, wearable devices can provide continuous blood pressure monitoring.

In the field of wearable monitoring, a range of Chinese consumer electronics manufacturers—including Huawei, Huami, and OPPO—as well as independent wearable medical device companies, demonstrate strong competitiveness. However, in the area of wearable therapeutics, there are very few domestic enterprises, indicating significant room for improvement.

Eke Medical Technology Co., Ltd. has independently developed the Yiyounuo wearable low-frequency therapeutic device for treating essential tremor (ET) and tremors caused by Parkinson’s disease (PD). It is the first non-invasive wearable medical device in China to target the thalamic central motor circuit via peripheral nerve stimulation, and it received its medical device registration certificate in April 2025. Xia Wei, the founder, believes that recent advancements in wearable therapeutic devices are the result of cross-disciplinary integration. On one hand, cutting-edge research in biomedicine continues to deepen, providing a theoretical foundation for precision treatment of diseases; meanwhile, the application of chip technology, big data, and materials science has collectively driven wearable therapeutic devices from concept to clinical application.

Eke Medical's Self-Developed EyouNuo Wearable Low-Frequency Therapeutic Device

He stated that it is precisely the continuous advancement of physiological monitoring technology that enables wearable monitoring devices to capture increasingly rich and refined physiological metrics, thereby providing a solid scientific basis for therapeutic wearables. Furthermore, the deep integration of cutting-edge technologies such as the Internet of Things (IoT), artificial intelligence (AI), big data, and VR/AR with wearable devices—particularly the analysis and processing of monitoring data by AI algorithms—can deliver personalized treatment plans and early warnings for patients. In addition, the growing diversity of intervention technologies is driving therapeutic wearables toward greater miniaturization and portability.

“Currently, wearable devices used for treatment and intervention in China are in a burgeoning early stage of development,” he stated.

Xia Wei believes that therapeutic wearable devices still differ fundamentally from earlier monitoring wearables: “In terms of product design, therapeutic wearables are essentially medical devices, with their core focus being on designing products to achieve specific therapeutic outcomes for particular diseases. In contrast, mainstream monitoring wearables currently on the market do not have disease-treatment functions; their industrial design must pursue a sense of fashion and lifestyle integration, otherwise they will fail to attract ordinary consumers.”

“In terms of business model, therapeutic wearable devices follow a serious medical approach, focusing on the treatment of specific diseases, with their value lying in providing patients with precise medical solutions. In contrast, mainstream monitoring wearable devices on the market adopt a mass-market consumer electronics approach, leaning towards health and quality-of-life orientations. They target individuals who have health needs and pay attention to health data, helping them maintain a healthy state through reminders and data monitoring.”

So, is it possible for these two approaches to converge in the future? Theoretically, this is not impossible. Various monitoring functions currently integrated into smartwatches, such as blood oxygen saturation (SpO2) measurement, initially appeared as standalone wearable devices. With technological advancements, the accuracy and level of integration of these monitoring features have gradually improved, while costs have decreased. Therefore, their incorporation into smartwatches by consumer brands is a logical development.

Xia Wei also expressed agreement with this view: “From a technical perspective, therapeutic wearables and monitoring wearables (consumer electronics) can potentially be integrated. Currently, leading companies such as Huawei and Apple have established product barriers by obtaining medical-grade certifications, thereby gaining certain advantages in both technology and the market.”

However, he believes that there is a critical prerequisite for realizing this possibility: “Regardless of how technologies converge, medical device certification is an indispensable step if a product is to become a true therapeutic wearable medical device, and it is the fundamental requirement distinguishing consumer electronics from serious medical products. The certification process itself represents substantial R&D investment, rigorous clinical validation, and professional post-market maintenance, all of which constitute high barriers to entry in the industry.”

Furthermore, professional medical enterprises hold a distinct advantage in post-market maintenance and patient engagement, enabling them to better meet patient needs: “We not only provide professional medical devices but also deliver meticulous and specialized patient engagement services. From personalized usage guidance and regular efficacy assessments to the establishment of patient communities and online support from professional physicians, we offer comprehensive post-market services. This ensures that patients can use our products correctly and effectively while receiving continuous therapeutic support. Such refined and specialized post-market operations are also key to building high user stickiness.”

Xia Wei believes that China’s current lag in therapeutic wearable devices is attributable to several factors.

First, the research and development of therapeutic wearable devices in China started relatively late. However, China already possesses a comprehensive ecosystem for wearable devices, spanning from components to design and manufacturing, and finally to clinical applications. Supported by this complete ecosystem, and with breakthroughs in key technologies such as sensors, chips, and materials science, there is a significant probability that China will achieve major advancements in this field.

Secondly, due to the effective marketing efforts of consumer brands, domestic consumers’ perception of wearable devices remains largely confined to that of electronic consumer goods. This has, to some extent, dampened domestic companies’ investment in therapeutic wearables, necessitating more time for market popularization and education.

Furthermore, the user experience of domestic therapeutic wearable devices urgently needs improvement. Currently, some wearable devices on the market still have room for enhancement in terms of wearing comfort and operational convenience, which will affect user acceptance and long-term adherence. User groups of different age brackets and economic levels also need more attention to ensure that products can better serve them.

Finally, regarding regulation and innovation, therapeutic wearables face stringent regulatory oversight in China as serious medical products. The rigorous market authorization process for medical devices and the relatively complex approval cycle can, to some extent, affect the speed at which small and medium-sized enterprises bring their products to market. Currently, therapeutic wearable devices on the market are primarily categorized into three types: disease treatment, rehabilitation assistance, and psychological intervention. The National Medical Products Administration (NMPA) is increasingly tightening its requirements for medical-grade certification of such devices.

However, he also pointed out that this high barrier to entry serves as an important moat, filtering for companies with genuine strength and responsibility to ensure product quality and patient safety. This not only helps regulate the market but also provides a strong guarantee for product quality and safety.

With the continuous advancement of technology, wearable devices are undergoing a disruptive transformation, particularly as AI empowerment unlocks ever-expanding possibilities. Currently, overseas demand for wearable intervention technologies is experiencing explosive growth, evidenced by the recent surge in innovative product launches and strengthened policy support. An increasing number of consumers are turning to therapeutic wearables to address health issues such as sleep disorders, chronic pain, anxiety, and depression, thereby disrupting the current healthcare model.

This trend not only reveals the broad application prospects of therapeutic wearables, but also signals immense market potential. China boasts what is likely the most comprehensive wearable device ecosystem globally; for instance, the sole CRO partner for the TRANQUIL clinical trial of the Felix NeuroAI wristband mentioned earlier is Tigermed Jietong, a domestic company. Therefore, although currently lagging behind, there is potential for late-mover advantage to overtake competitors.

On the other hand, vigorously promoting the adoption of wearable devices (whether for monitoring or therapeutic purposes) holds significant value from a healthcare perspective. In the future, this sector is likely to continue attracting technological and capital attention, becoming a core track in global health technology innovation.

VCBeat will continue to monitor developments in this field and welcomes insights from industry professionals.

References:

Mary Kekatos，abcnews.go.com：RFK Jr. wants everyone to use wearables. What are the benefits, risks?

Tigermed Jietong: Tigermed Jietong Supports FDA Approval of Felix™ NeuroAI™ Wristband, the World’s First “AI+” Device for Essential Tremor Treatment

Jasmine Pennic，hitconsultant.net：New Android SONU App Turn Selfies into Drug-Free Sinus Relief

Sean Whooley，massdevice.com：Fasikl wins FDA nod for tremor-treating wearable wristband

Chris Newmarker，massdevice.com：Novocure wins CE mark for its lung cancer treatment wearable

NHS：Fit for the future 10 year health plan for England