Published: September 2023
Top digital therapeutics companies have been meticulously selected based on a proprietary company competitiveness analysis, taking into consideration their portfolio strength and recent initiatives. These companies are at the forefront of pushing the boundaries of digital therapeutics.We analyzed a comprehensive list of digital therapeutic companies that have the required capabilities to offer digital therapeutics in the healthcare market. In this article, discover 10 leading digital therapeutics companies and their capabilities in this industry.
Digital therapeutics (DTx) is a rapidly growing field that is transforming healthcare by providing evidence-based therapeutic interventions to prevent, manage, or treat medical disorders or diseases. The potential of DTx to improve patient outcomes and reduce healthcare costs has led to the emergence of several digital therapeutics companies. Lately, several digital therapeutics companies are leveraging digital technologies to provide personalized, accessible, and cost-effective solutions for chronic diseases management. Digital therapeutic companies are disrupting the healthcare industry by providing innovative solutions that address the unmet needs of conventional therapeutics. These companies are leveraging data analytics, artificial intelligence, and behavioral psychology to provide alternative methods of chronic diseases treatment. Digital therapeutics can be used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. The potential of DTx to improve individual patient outcomes and healthcare at a system level is enormous. As the field continues to evolve, it is crucial to develop regulatory frameworks that ensure the safety and efficacy of digital therapeutics. The future of healthcare is digital, and digital therapeutic companies are at the forefront of this transformation. Owing to the increased adoption rate of digital solutions and rise in the demand for remote healthcare services, the companies involved in the digital therapeutics market have witnessed a surge in the investment activity, with capital investments worth more than USD 10 billion in the past five years.
Further, digital therapeutics have shown tremendous growth potential in the healthcare industry, with the digital therapeutics market expected to grow at a CAGR of 19.69% during the forecast period of 2022-2035. The COVID pandemic has accelerated the adoption of virtual care, including digital therapeutics, to address mental health concerns. Cognitive behavioral therapy (CBT) is a non-pharmacological treatment that has shown efficacy in mitigating mental health problems. DTx companies, such as Omada Health, and Click Therapeutics have developed digital therapeutics for mental health conditions, such as major depressive disorder, substance use disorder, and opioid use disorder. Clinical trials have demonstrated the effectiveness of these digital therapeutics in improving patient outcomes. DTx companies are also leveraging growth factors, such as data analytics, artificial intelligence, and behavioral psychology to develop innovative business models for chronic diseases management. Trinity Health, for example, has partnered with Proteus Digital Health to develop a digital therapeutic for hypertension management. Kaia Health has developed a digital therapeutic for chronic pain management, while Akili Interactive has developed a digital therapeutic for attention deficit hyperactivity disorder (ADHD). These examples demonstrate the potential of DTx to address unmet needs in chronic diseases management and improve patient outcomes. Furthermore, digital therapeutics are also making headway in to women’s health disorders. Renovia Inc. has FDA approval for leva® Pelvic Health System to treat stress, mixed and mild-to-moderate urinary incontinence and chronic fecal incontinence in women. Another company, Natural Cycles is active in the birth control market.
Roots Analysis has conducted an exhaustive study on Digital Therapeutics Market featuring the current market landscape, market size and future opportunity for the digital therapeutics companies, over a span of 13 years.
The top digital therapeutics companies are listed below (in alphabetical order):
Interested in exploring all Digital Therapeutics Companies and their Use Cases in Healthcare Industry?
This article highlights the top 10 digital therapeutics companies to watch out for in the healthcare industry. These companies were chosen based on proprietary company competitiveness analysis, taking into consideration their portfolio strength and recent initiatives. It is essential to note that the selection of top players can differ substantially according to the defined criteria(s).
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Akili Interactive is a US-based digital therapeutics company focused on the development of digital medicine. The company has a broad pipeline of products to treat cognitive deficiency disorders, and for improving the symptoms associated with multiple medical conditions across the fields of neurology and psychiatry. The company’s digital health solutions are delivered via innovative and immersive, action, video game-based experiences. It currently claims to use three core technologies, namely the selective stimulus management (SSME) engine, Spatial Navigation (SNAV), Body Brain Trainer (BBT), for the designing and development of digital solutions. In 2021, the company received the USFDA approval for its first proprietary product EndeavorRx which was launched in the US. The product also received CE mark in June 2020, however it is not launched in European markets yet.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics | Product Details |
| 1 | AKL-T01 / Endeavor Rx | The company is engaged in the development of a prescription gaming solution for the treatment of children with attention-deficit / hyperactivity disorder as an alternative to medication. In fact, the solution has been validated to provide therapeutic effect within four weeks. |
| 2 | AKL-T02 | The company is engaged in the development of a prescription gaming solution for the treatment of attention-deficit / hyperactivity disorder as an alternative to medication. |
| 3 | AKL-T03 | The company is engaged in the development of a prescription gaming solution for the treatment of adults with major depressive disorder as a supplement to medication. In fact, the solution has been validated to provide therapeutic effect within six weeks. |
| 4 | AKL-T04 | The company is engaged in the development of a prescription gaming solution for the treatment of adults with major depressive disorder as a supplement to medication. |
| 5 | AKL-T05 | The company is engaged in the development of a prescription gaming solution for the treatment of multiple sclerosis as an alternative to medication. |
| 6 | Unnamed | The company is engaged in the development of a prescription gaming solution for the treatment of major depressive disorder, multiple sclerosis, autism spectrum disorder, COVID brain fog as an alternative to medication. |
Focus Therapeutic Area(s): Mental Health and Neurological Disorders
Targeted Population: Children (8-12), Adolescent (13-17), Adults (18+)
Recent Developments: In June 2023, Akili Interactive released video game, EndeavorOTC, for the treatment for adults with ADHD under a non-prescription model. Company is also planning to submit the app for the FDA clearance as an OTC treatment for adults with ADHD in near future.1
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Big Health is a US-based digital therapeutics company, that is engaged in providing digital solutions, that are fully automated and highly personalized therapeutics for the treatment of mental health disorders. The company’s products are based on certain cognitive behavioral therapy techniques. The company claims to develop two evidence digital solutions, namely Sleepio and Daylight, for the treatment of insomnia and anxiety, respectively. The third product SparkRx was added to the portfolio through the acquisition of Limbix. In addition, the company is a member of the prestigious digital therapeutic alliance (DTA).
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics | Product Details |
| 1 | Sleepio | The company has developed a software solution that operates along with AI support for the treatment of adults with insomnia as an alternative to medication. In fact, the solution has been validated to provide therapeutic effect within six to twelve weeks. |
| 2 | Daylight | The company has developed a software solution that operates along with AI support for the treatment of adults with anxiety and worry as a supplement to medication. |
| 3 | SparkRx | The company has expanded its portfolio with the acquisition of Limbix, an app for the treatment of adolescent depression and adolescent anxiety . |
Focus Therapeutic Area(s): Mental Health Disorders
Targeted Population: Adolescent (13-17), Adults (18+)
Recent Developments: In July 2023, Big Health acquired Limbix, the creator of the first evidence-based digital therapeutic for depression in teens and young adults. This acquisition expands Big Health's therapeutic portfolio to include SparkRx for adolescent depression and an adolescent anxiety product in development, in addition to its flagship programs for adult patients.2
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dreem is a France-based digital therapeutic company that claims to develop therapeutic solutions to treat sleep disorders and help patients in order to treat insomnia and sleep apnea. In addition, the company claims to employ a sleep monitoring technology called polysomnography (PSG) and sensors that are capable of measuring biomarkers to provide accurate results.
Digital Therapeutics Marketed and Pipeline Products
| Digital Therapeutics | Product Details |
| Dreem Coach | The company has developed a software solution that operates along with a device for the treatment of teenagers and adults with insomnia as an alternative to medication. |
Focus Therapeutic Area(s): Sleep Disorders
Targeted Population: Adolescent (13-17), Adults (18+)
Recent Developments: In July 2023, Beacon Biosignals, a Boston-based computational neurodiagnostics and electroencephalogram (EEG) analytics company, announced the acquisition of dreem. The integration of dreem's hardware with Beacon's platform will enable the company to offer a comprehensive solution for clinical trial assessments, providing valuable insights into brain activity and neurological disorders.3
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Kaia Health is a Germany-based digital therapeutic company focused on the development of evidence-based digital therapeutic solutions for a wide range of therapeutic areas, including musculoskeletal disorders and chronic obstructive pulmonary disease. In addition, the company claims to be engaged in the development of digital therapeutic solutions for osteoarthritis, Parkinson’s disease, and several other indications in the near future. It is worth mentioning that the company is a member of the digital therapeutic alliance.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics | Product Details |
| 1 | Kaia MSK | The company has developed a software solution that operates along with a personal coach for the treatment of adults with chronic back pain as an alternative to medication. |
| 2 | Kaia COPD | The company has developed a software solution that operates along with AI support for the treatment of adults with chronic pain as an alternative to medication. In fact, the solution has been validated to provide therapeutic effect within twelve weeks. |
Focus Therapeutic Area(s): Chronic Diseases
Targeted Population: Adults (18+)
Recent Developments: In June 2023, Kaia Health announced the launch of Angela, a HIPAA-compliant, AI-powered voice-based digital care assistant, companion, and guide. Angela is designed to provide patients with personalized support at their convenience, creating a more human-like experience. The launch of Angela is a strategic move by Kaia Health to expand its digital therapeutics portfolio and cater to the growing demand for personalized care. Angela's AI-powered voice-based interface enables patients to receive support and guidance in a conversational manner, making it easier for them to manage their health and wellness.4
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MindMaze is a software developer, which is also engaged in the development of evidence-based digital therapeutic solutions. The company claims to have designed a mind / machine interface, which incorporates the use of neural prediction networks to decode the brain signals. It leverages its expertise in neuroscience, mixed reality and artificial intelligence, in the development of its proprietary solutions.
MindMaze’s MindMotion Go was approved in June 2018. Earlier, in February 2016, company had received CE mark for MindMotionPRO, followed by FDA approval in May 2017. Additionally, in September 2019, company had received CE mark for Intento PRO.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics | Product Details |
| 1 | MindMotion PRO | The company has developed a prescription gaming solution that operates along with a device for the treatment of neurorehabilitation as an alternative to medication. |
| 2 | MindMotion GO | The company has developed a prescription gaming solution that operates along with a device for the treatment of neurorehabilitation as an alternative to medication |
| 3 | MindPod Dolphin | The company has developed a prescription gaming solution that operated with a device to promote the recovery of motor skill and cognitive function. |
| 4 | Intento PRO | The company has developed a solution that operates with a device based on self-modulated functional electrical stimulation. |
| 5 | TOAP Run | The company has developed a prescription gaming solution that operates with a device which delivers fast and big movements therapy to the Parkinson’s disease patients |
| 6 | MeMo | The company has developed a prescription gaming exercise that operates along with a device for the treatment of patients with cognitive disorder. |
| 7 | e-GOLIAH | The company has developed a prescription gaming solution that operates along with a device for the treatment of patients with autism spectrum disorder (ASD). |
| 8 | X-TORP | The company has developed a prescription gaming solution that operates along with a device for the treatment of patients with gait and balance disorders. |
| 9 | MindPod | The company has developed FDA-listed and CE-marked neurobehavioral platform in collaboration with Johns Hopkins University School of Medicine. |
Focus Therapeutic Area(s): Neurological Disorder
Targeted Population: Adults (18+)
Recent Developments: In December 2022, MindMaze, announced a strategic partnership with Vibra Healthcare, a renowned provider of post-acute hospital patient care. The partnership involved the deployment of MindMaze's cutting-edge digital health technology platform, MindPod® and MindMotion®GO, in selected Vibra hospitals in Kentucky and California, both in-clinic and at-home for patients. This innovative partnership is likely to revolutionize patient care by enabling clinicians to provide personalized interventions at dosage and intensity levels that far exceed the current standard of care.5
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Omada Health is a US-based digital therapeutics company engaged in the development of therapeutic solutions to address existing unmet needs associated with the treatment / management of chronic disorders, such as diabetes, heart diseases and obesity. One of the key goals of the company is to improve health and reduce risk of chronic diseases by enabling lifestyle modification in their users.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics | Product Details |
| 1 | Omada Prediabetes | The company has developed a software solution that operates along with a personal coach and a device for the treatment of adults with prediabetic condition. In fact, the solution has been validated to provide therapeutic effect within 16+ weeks. |
| 2 | Omada Diabetes | The company has developed a software solution that operates along with a personal coach and a device for the treatment of adults suffering with Type II – Diabetes. The solution has been validated to provide therapeutic effect within 9-12 weeks. |
| 3 | Omada Hypertension | The company has developed a software solution that operates along with a personal coach and a device for the treatment of adults suffering with Hypertension. |
| 4 | Omada MSK | The company has developed a software solution that operates along with a personal coach and a device for the treatment of adults suffering with Musculoskeletal Pain. |
Focus Therapeutic Area(s): Chronic Diseases and Musculoskeletal Disorder
Targeted Population: Adults (18+)
Recent Developments: In February 2023, Omada Health announced the closing of USD 192 million Series E funding round led by Fidelity Management & Research Company and other existing investors. The funding amount will be used to accelerate hiring, advance the technological roadmap for care personalization, and increase investment in the Omada Insights Lab.6
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Vida Health is a digital therapeutic company that offers a continuous care platform for the treatment of patients suffering from chronic conditions. The company’s digital therapeutic solution is designed to target both physical and behavioural components of health. Further, the primary aim of the company is to build a healthy connection between the patients and healthcare professionals through this digital platform, and enable positive health outcomes.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics | Product Details |
| 1 | Vida Health Diabetes Management | The company has developed a software solution that operates along with personal coach for the management of diabetes, as an alternative to medication, for teenagers and adults. |
| 2 | Vida Health Diabetes Prevention | The company has developed a software solution that operates along with personal coach for the prevention of diabetes, as an alternative to medication, for teenagers and adults. |
| 3 | Vida Health – Hypertension | The company has developed a software solution that operates along with personal coach for the treatment of hypertension, as an alternative to medication, for teenagers and adults. |
| 4 | Vida Health – Depression | The company has developed a software solution that operates along with personal coach for the treatment of depression, as an alternative to medication, for teenagers and adults. |
| 5 | Vida Health – Depression | The company has developed a software solution that operates along with personal coach for the treatment of anxiety, as an alternative to medication, for teenagers and adults. |
| 6 | Vida Health – Insomnia | The company has developed a software solution that operates along with personal coach for the treatment of insomnia, as an alternative to medication, for teenagers and adults. |
Focus Therapeutic Area(s): Chronic Diseases
Targeted Population: Adolescents (13-17), Adults (18+)
Recent Developments: In February 2023, Vida Health announced the expansion of its cardiometabolic capabilities to include GLP-1s for diabetes management and weight loss. This strategic move allows Vida Health to provide patients with obesity and type 2 diabetes a more comprehensive set of options for managing their conditions, including medication management, personalized care plans, medical nutrition therapy, remote monitoring, and therapy for depression and anxiety. This expansion aligns with Vida Health's commitment to leveraging digital health technology to improve patient outcomes.7
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Voluntis (acquired by Aptar Digital Health) is a France-based digital therapeutic company that is engaged in developing prescription- based solutions, by combining medical intelligence within a smartphone application, to help people suffering from chronic disorders. The company also claims to offer a personalized treatment experience by establishing a link between the patient and his / her doctor. It further aims to develop evidence-based solutions, aligning the interest of patients, providers and payers, that transform the healthcare domain. Moreover, the firm mentions that its digital therapeutic solutions are considered as software medical devices and are developed in compliance with the following regulatory standards such as USFD, CE, ISO, IEC and others. It is interesting to note that in August 2019, company received FDA clearance for Oleena, which is first digital therapeutic in oncology. Further, December 2016, company received the FDA 510(k) clearance, as well as the CE Mark, for Insulia®.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics Solution | Product Details |
| 1 | Diabeo | The company has developed a prescription software solution that operates along with a device for the treatment of adults with diabetes as a supplement to medication. |
| 2 | Insulia | The company has developed a prescription software solution that operates along with a personal coach for the treatment of adults with diabetes as a supplement to medication. |
| 3 | Oleena | The company has developed a prescription software solution that operates along with a personal coach for the treatment of adults with oncological disorders as a supplement to medication. |
Focus Therapeutic Area(s): Oncology and Chronic Diseases
Targeted Population: Adults (18+)
Recent Developments: In June 2023, Aptar Digital Health, the parent company of Voluntis, announced a partnership with Tasso, the leading provider of patient-centric, clinical-grade blood collection solutions. This collaboration aims to offer Aptar Digital Health end-users’ access to Tasso's innovative devices for blood collection, with a focus on improving patient care through a simplified and integrated experience. By leveraging Tasso's advanced solutions, Aptar Digital Health aims to deliver clinical value, drive the adoption of new technologies, and enhance the overall healthcare experience for patients, providers, and pharmaceutical companies.8
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WellDoc is a digital therapeutic company that is engaged in helping patients in managing chronic diseases through digital therapeutic solutions. The company is focused on reducing the overall healthcare costs by assisting healthcare professionals and health systems in providing hands-on, guided care to patients, thereby, transforming the management of type II diabetes. Further, it has developed online treatment programs by incorporating everyday technologies, such as the internet and smartphones, to enhance patient engagement and improve clinical outcomes. The firm also claims that it is the first digital health company to operate on a life science business model. It further states that it follows an aggressive and innovative approach that utilizes sophisticated logic and precise algorithms for managing the condition of patients suffering from type II diabetes.
Digital Therapeutics Marketed and Pipeline Products
| S. No. | Digital Therapeutics Solution | Product Details |
| 1 | BlueStar | The company has developed a standalone software solution for the treatment of adults with diabetes as a supplement to medication. |
| 2 | BlueStarRx | The company has developed a prescription standalone software solution for the treatment of adults with diabetes as a supplement to medication. |
| 3 | BP Star | The company has developed a prescription standalone software solution to promote, track, and encourage healthy choices among individuals with existing diagnoses of hypertension (high blood pressure). |
| 4 | HF Star | The company has developed a prescription based standalone software solution designed to support people suffering risk heart failure. The app simply serves as a tracker, coaching, education, and self-accountability. |
| 5 | DPP Star | The company has developed a prescription based standalone software solution for the treatment of patients suffering from type 2 diabetes. |
Focus Therapeutic Area(s): Chronic Diseases
Targeted Population: Adults (18+)
Recent Developments: In August 2023, WellDoc received 11th 510(k) clearance from the USFDA for BlueStar®, its award-winning diabetes digital health solution. This clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations, demonstrating WellDoc's commitment to transforming chronic care. The achievement solidifies WellDoc's position as a leading innovator in the digital health industry, offering a more personalized and effective approach to diabetes management.9
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Wellthy Therapeutics is a pioneering prescription digital therapeutics company headquartered in India. The company’s mission is to inspire and enable millions of patients with chronic diseases to reverse, prevent or control their condition by 2025. The company uses a hybrid of human and artificial intelligence enabled real time care in order to enable healthcare providers, insurers, pharmaceutical and medical device companies to substantially improve their patient outcomes.
Digital Therapeutics Marketed and Pipeline Products
| Digital Therapeutics | Product Details |
| Wellthy Care | The company has developed a software solution that operates along with AI support and personal coach for the treatment of adults with diabetes as a replacement to medication. In fact, the solution has been validated to provide therapeutic effect within sixteen weeks. |
Focus Therapeutic Area(s): Chronic Diseases
Targeted Population: Adults (18+)
Recent Developments: In May 2023, Wellthy Therapeutics announced the successful completion of its FDA 21 CFR Part 820, FDA 21 CFR Part 11, and HIPAA certification for its disease-agnostic, modular, software-as-a-medical-device (SaMD) platform, following its expansion into the US. These international registrations reinforce the company's commitment to maintaining the highest standards of data security, data privacy, quality, and regulatory compliance in the development and manufacturing of digital health solutions for customers in the US and worldwide. The certifications also solidify Wellthy Therapeutics' leadership in the SaMD space, enabling it to offer a simplified and integrated experience, delivering clinical value to patients through real-world deployment, and increasing adoption of new technologies by patients, providers, and pharmaceutical companies.10
The above presentation features ten promising players from a pool of over 155 digital therapeutics companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
Ronit Sharma is an accomplished business research and competitive intelligence professional with over six years of experience in the pharmaceutical and healthcare industry. As a team leader at Roots Analysis, he has authored numerous multidisciplinary market research reports, and led the efforts on several bespoken consulting assignments, providing valuable insights into the latest innovations in healthcare and the digital transformation of the pharmaceutical industry. Ronit's exceptional analytical skills and strategic thinking in the field contribute to the firm's intellectual capital, empowering clients to make informed decisions in the dynamic pharmaceutical landscape. With a passion for staying at the forefront of industry advancements, Ronit specializes in identifying emerging opportunities for various stakeholders, leveraging his deep understanding of market trends and technological developments. He is committed to fostering an environment of excellence, creativity, and innovation within his team, encouraging collaboration and empowering team members to bring their best ideas to the table.
Recently, Ronit's expertise has been recognized by the online news agency, Eat My News, where he was interviewed and featured as an emerging industry leader. Ronit holds a B. Tech degree in Biotechnology from Lovely Professional University and his research and thought leadership can be found in his professional blog and social media profiles, where he shares the latest insights and engages in meaningful discussions with industry peers. To ensure the highest ethical standards, Ronit openly declares no conflicts of interest in his work, ensuring unbiased and trustworthy contributions. His insights undergo rigorous editorial and peer-review processes, establishing his credibility as a thought leader within the pharmaceutical and healthcare domain. Ronit's exceptional analytical and strategic thinking skills, coupled with his commitment to excellence, make him a valuable asset to any organization in the pharmaceutical and healthcare industry.
Email: ronit.sharma@rootsanalysis.com
LinkedIn: https://www.linkedin.com/in/ron001/
Source 1: https://www.statnews.com/2023/06/07/adhd-akili-fda-adults-game-endeavorrx/
Source 2: https://www.bighealth.com/news/big-health-acquires-limbix-and-expands-into-adolescent-mental-health/
Source 3: https://www.finsmes.com/2023/07/beacon-biosignals-acquires-dreem.html
Source 4: https://www.prnewswire.com/news-releases/kaia-health-launches-industrys-first-digital-care-assistant-giving-patients-a-companion-and-guide-to-enhance-their-physical-therapy-experience-301846125.html
Source 5: https://mindmaze.com/mindmaze-and-vibra-healthcare-partner-to-deliver-advanced-digital-medicine-and-neurorehabilitation-solutions-for-patients-from-clinic-to-home%ef%bf%bc/
Source 6: https://www.globenewswire.com/news-release/2022/02/23/2390428/0/en/Omada-Health-Closes-192-Million-Series-E-Financing-to-Bring-Virtual-First-Care-to-Millions.html
Source 7: https://www.businesswire.com/news/home/20230213005215/en/Vida-Health-Expands-Its-Cardiometabolic-Capabilities-to-Include-GLP-1s-for-Diabetes-Management-and-Weight-Loss
Source 8: https://www.aptar.com/news-events/aptar-digital-health-and-tasso-combine-capabilities-to-facilitate-blood-sample-collection-for-multiple-indications-including-chronic-conditions-and-oncology/
Source 9: https://www.businesswire.com/news/home/20230823298365/en/Welldoc-Receives-11th-510-k-Clearance-from-FDA-for-Award-Winning-Diabetes-Platform-BlueStar%C2%AE
Source 10: https://www.prnewswire.com/in/news-releases/wellthy-therapeutics-announces-expansion-into-the-united-states---completes-fda-cfr-part-11-fda-cfr-part-820-and-hipaa-certification-for-its-platform-301821891.html
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