DarioHealth Corp. (Dario) operates as a direct-to-consumer digital therapeutics company.
The company expanded from a single-condition platform to a multi-condition platform, creating a robust suite of solutions to address the five most commonly co-occurring, behaviorally driven, and expensive chronic conditions, which are also representative of some of the most sought-after digital health solutions: diabetes, hypertension, pre-diabetes/weight management, musculoskeletal and behavioral health....
DarioHealth Corp. (Dario) operates as a direct-to-consumer digital therapeutics company.
The company expanded from a single-condition platform to a multi-condition platform, creating a robust suite of solutions to address the five most commonly co-occurring, behaviorally driven, and expensive chronic conditions, which are also representative of some of the most sought-after digital health solutions: diabetes, hypertension, pre-diabetes/weight management, musculoskeletal and behavioral health. After building weight loss and hypertension management into the legacy diabetes platform, the company made three acquisitions in order to expand into musculoskeletal (MSK) and behavioral health (BH). In that regard, the company acquired Upright Technologies Ltd. (Upright), PsyInnovations Inc. (PsyInnovations) and Physimax Technology assets to expand into the fields of MSK and BH. The company’s approach to integrating all solutions into one digital therapeutics platform follows the best-of-suite offering design principal which provides the user one place to monitor all identified chronic conditions and to deliver a seamless user experience for commonly co-occurring chronic conditions.
The company continues to achieve key benchmarks as it rapidly scales its B2B2C model, including more than 100 total signed contracts as of December 31, 2023, and the shift in its commercial pipeline where more than 50% of the contracts signed in the second half of 2022 are for multi-chronic solutions. In January 2024, the company launched the Aetna platform with several customers, and it has continued to add customers that are planned for launches through the second quarter of 2024. The company anticipates additional health plan customers in 2024 directly and through its partners that cover more than 87 million members.
Product Offering
The company’s user-centric software platform integrates digital therapeutics, coaching, professional human support and medical devices to drive superior clinical and financial outcomes. The company’s best-of-suite suite of offerings is modular, allowing for enterprise clients to purchase one or more of its chronic condition management solutions, while enjoying the same best-in-class experience supported by its behavior change journey engine so its partners can be confident in achieving sustainable outcomes and value. The company’s suite of digital offerings includes:
Dario Metabolic (Dario Evolve)
The company’s metabolic solutions are designed to address some of the most commonly co-occurring metabolic health needs - diabetes, pre-diabetes, hypertension, and weight management - through a combination of software, its smartphone-connected tools, interaction with live coaches, and real-time data analysis to help inform and educate users of the relationship between their behaviors and their health outcomes to drive changes that last.
Dario Musculoskeletal (Dario Move)
The company’s unique approach addresses the most common MSK conditions, including chronic pain, by dealing with the cause and empowers users to create behavioral change. Dario Move’s digital physical therapy programs and posture training help people improve strength and mobility by using a combination of software, wearable biofeedback sensors, and coaching to drive sustainable improvements in musculoskeletal health. The inclusion of posture training in the solution supports ongoing engagement in support of prevention and maintenance outside of an exercise therapy program.
Dario Behavioral Health (Dario Elevate)
The company’s behavioral health solution optimizes access to evidence-based care by using an AI-driven screener to triage users and connect them to the most appropriate support across a wide range of mental health needs, including its integrated digital tools and coaching, giving users a seamless path to proven mental health support.
Dario Full Suite (Dario One)
The company’s full suite of chronic condition management solutions offers the maximum benefit for its partners with a completely seamless and holistic approach to managing chronic conditions. In addition to a better unified member experience, its partners deploying Dario One enjoy several benefits from purchasing the entire suite of solutions: better overall health as evidenced by recent research published by it; the convenience and ease of a single vendor to manage; less strain on internal resources spread across several chronic condition management programs; and a more affordable program launches due to lower costs of implementation.
Dario’s Solution Main Components
The company’s journey engine drives its multichannel targeted outreach and enrollment campaigns, informs specific recommendations around a range of categories, such as diet, physical activity, self-care, coaching interventions, and provider engagement, and evolves in real time in response to the data exhaust from a user’s interaction with the care ecosystem.
The company’s journey engine combines complex behavioral science insights with data from hundreds of thousands of users over several years to recommend AI-driven initial and updated care journeys in response to a user’s engagement with the platform. Most digital health solutions consist primarily of tracking, content, and nudges. These are often perceived by users as non-rewarding work, and often do not feel relevant to their concerns, particularly as they evolve over time. The company’s journey engine adapts user journeys to drive engagement, retention, and clinical outcomes by optimizing timing, tone, channel, content, frequency and intervention to deliver dynamically personalized user journeys that are more likely to result in the behavior changes needed to drive improved outcomes across a range of conditions. As it partners with solutions in additional conditions or categories, the company engages new populations and generate fresh insights, enhancing the engagement and efficacy of these partnered solutions to deliver additional value to its users. The engine is designed for integration and scale; as the company adds populations and conditions for which behaviors are primary drivers of outcomes, its engine becomes more adept at customizing a user’s evolving preferences and needs.
Software Applications
The company’s chronic condition management solutions are designed as three separate software applications to provide the best possible user experience across metabolic, MSK and behavioral health needs. Each application is integrated with Dario’s single digital therapeutics platform and behavior change journey engine to ensure the same hyper-personalized experience across each person’s unique health needs and preferences to keep them on track with healthy changes over time.
Dario Evolve
Dario Evolve helps users change their behaviors and help better manage their diabetes, blood pressure and weight. Using real-time data and analysis, the app helps users track their progress and offers real-time feedback and customized content to support each individual’s needs and goals.
Dario Move
Dario Move helps users improve strength and mobility to help address chronic pain and improve overall musculoskeletal health. After completing an online assessment, each user receives a personalized, evidence-based exercise program that can be adjusted throughout their journey based on sensor data or self-reported feedback to a coach or in the app. Dario Move guides members through their tailored program with educational content to support long-term outcomes.
Dario Elevate
Dario’s Elevate helps people get the help they need to address common mental health needs. Starting with a responsive, AI-driven screener, elevate triages users to understand the need and recommend the most appropriate support to help them feel better. The company’s integrated, evidence-based digital tools and coaching help people learn proven techniques to better manage their emotional health.
Live Coaching
Live coaching is available as part of the Dario experience to give members a human point of contact for support and motivation, and also provide a level of accountability that is proven to help improve engagement and outcomes. As an integrated component of the company’s suite of solutions, its professionally trained and certified health coaches serve as a personal support for each member throughout their journey across all solutions and are able to connect members with clinical experts when members need additional support. The company’s clinical coaches include Certified Diabetes Educators (CDCES), Registered Nurses, Pharmacists and Mental Health Clinicians who are able to assist members throughout their journey.
Dario User Devices
The company’s product offerings include integrated devices to capture relevant clinical and biofeedback data to support continuous, real-time monitoring of member health. The company’s native devices include all-in-one smart glucose meter; Bluetooth connected blood pressure cuff; digital scale; and biofeedback sensor device.
Commercial Channels
The company focuses on the go-forward business strategy around three key market opportunities: direct sales to employers and payers and partnerships with the ability to multiply its growth opportunities. The company’s scalable business model selling digital therapeutics as a service through multi-year contracting relationships establishes a pipeline of ARR and has the potential to improve its gross margins over time.
The company’s software solutions are sold across a range of channels to create multiple growth engines and support rapid adoption across all segments of the market. The company’s integrated product suite is designed to address a common and growing sentiment from enterprise customers expressing frustration with the large number of condition-specific solutions, lack of transparency, lackluster results and poor member experiences. The company’s integrated solution aligns with these key buyer pain points and is proven to deliver value to strategic partners through its differentiated approach in the market. Finally, the company’s consumer-centric legacy remains a key component of its commercial strategy, bolstering its ongoing solution development by serving as an innovation laboratory for new services and product enhancements.
Health Plans: Although health plans represent the longest and most complex purchasing cycle across the company’s client base, these contracts often represent sizeable opportunities as they typically offer much larger potential member populations. The company has three live contracts with health plans, two are regional payers and one is a large national plan, with several additional plans in negotiation and contracting at present day.
Employers: The company’s most robust growth in 2022 came from the employer market, a key buyer to help demonstrate its ability to deliver results. The company has approximately 120 employer populations actively on its platform, and growth of its employer pipeline continues to grow and mature.
Partnerships: Strategic partnerships play a key role in helping to expand the company’s reach across markets quickly and efficiently. The company’s consumer-centric platform, the rate at which we have evolved its product, added and integrated solutions and provided product improvements and ability to easily share data and support a multitude of integrations makes Dario an attractive choice of partner for many in the market. One such significant partnership agreement is the company’s collaboration with Sanofi, a global leader in health care, a relationship that resulted after an extensive search determined it is uniquely capable of providing the robust data and analytics required by Sanofi. The company also entered into partner agreements with several large employer benefits platforms such as Virgin Health Pulse in 2021, helping expand our reach within the employer market. The company also entered into partnership agreements with several large platforms, such as Virgin Health Pulse, Alliant Insurance Services, and Vitality Group, helping expand its reach within the employer market. Dario is actively pursuing new partnerships in both markets to enhance our opportunities with a one-to-many approach.
Consumers: The company’s ability to engage members and improve health begins with its consumer-centric approach, and this audience remains key to its commercialization at the enterprise client level. The company’s direct-to-consumer channel continues to attract members to its platform and provides a neutral audience to test innovative product ideas, something traditional B2B companies are unable to do given limitations on commercial membership. These insights inform both the company’s AI-driven behavior change journey engine, helping continuously improve engagement and retention, and inform product design to ensure its solutions remain at the forefront of consumer expectations.
Sanofi U.S. Agreement
On February 28, 2022, the company entered into an exclusive preferred partner, co-promotion, development and license agreement (the Agreement) with Sanofi for a term of five (5) years. Pursuant to the Agreement, the company and Sanofi will co-promote certain of its products and services, including devices and accessories, and to develop new products and services based on insights derived from its data relating to the use of those devices and services. In addition, the company granted Sanofi a license to access and use certain of its data, and Sanofi granted it a license under certain intellectual property of Sanofi for purpose of developing and promoting certain products and services for Sanofi in the United States.
In July 2023, the company entered into an amended and restated strategic agreement with Sanofi, an innovative global healthcare company.
Intellectual Property
Patent Applications
On May 8, 2011, certain of the company’s founders filed a Patent Cooperation Treaty (PCT) Application No. PCT/IL2011/000369, titled Fluids Testing Apparatus and Methods of Use. This PCT claimed priority from two preceding U.S. provisional applications filed by the company’s founders, with the earliest priority date being May 9, 2010. The PCT application was transferred to the company by its founders on October 27, 2011.
On May 1, 2014, the company announced the receipt of a U.S. Notice of Allowance for a key patent relating to how the Dario Blood Glucose Monitoring System draws power from and transmits data to a smartphone via the audio jack port. This patent was issued as U.S. Patent No. 8,797,180 in August 2014, and in August2015, the company received U.S. patent (No. 9,125,549) that broadened its registered patent No. 8,797,180 to include testing of other bodily fluids through an audio jack connection. These early patents represent critical intellectual property recognition and a significant initial validation of the company’s intellectual property efforts. Further, a corresponding European patent was granted to the company in May 2016, as European patent No. 2569622 for testing of fluids through an audio jack connection. An additional corresponding patent was granted in Israel in April 2016.
On November 11, 2017, U.S. patent No. 9,832,301 titled Systems and methods for adjusting power levels on a monitoring device was granted. This patent enhances the way the Dario Blood Glucose Monitoring System communicates with users’ smartphone devices. This family includes a corresponding pending application in China.
Additionally, the company recently received U.S. patent No. 10,445,072 that enables optical communication between the Dario Blood Glucose Monitoring System and the end user’s smartphone devices.
In early 2022, the company acquired Physimax and acquired the following patent – US 10,709,374 B2 titled System and Method for Assessment of Musculoskeletal Profile of a Target Individual.
This patent was also submitted as EP application #19767795.8 on the 05/03/2019 and is pending.
Design patents and patent applications on the Dario Blood Glucose Monitoring System
To further protect the company’s market distinction and branding for the Dario Blood Glucose Monitoring System, three U.S. Design Applications have been filed and granted covering the glucose meter, the cartridge, and connection dongle. At least some of these applications were granted and registered in the United States, as well as Canada, Europe, and Hong Kong.
Trademark Applications
The company has also filed several families of trademark applications covering the Dario name (wordmark), the Dario name and logo (logo), the Dario logo alone (logo), the DARIO-LITE wordmark, the LABSTYLE INNOVATIONS wordmark, the DARIOHEALTH wordmark, and the DARIOHEALTH logo. In particular, the Dario wordmark is registered as a trademark in Australia, Canada, China, Costa Rica, United States, Israel, Hong Kong, South Africa, Japan, Costa Rica, Europe, Israel, Korea, Mexico, New Zealand, Panama and Russia. The DARIOHEALTH wordmark is registered as a trademark in the United States, Canada, China and India.
Upright also added the following trademarks to the company’s list: UPRIGHT, UPRIGHT GO – registered in the U.S., AU and EM, and UPRIGHT DASHBOARD, UPRIGHT DESKTOP, UPRIGHT GO 2, UPRIGHT POSTURE IS WITHING REACH – registered in the U.S.
Utility Models
The company has been granted Utility Models for its core invention in Japan.
Other Intangible Assets
As the number of Dario users grows, an ever-growing amount of data is being collected from diabetic patients, including their blood sugar levels, meal compositions, routines, physical exercise (intensity and duration), as well as many other factors, and lately also blood pressure data, which are all useful for creating meaningful correlations between these factors and insulin use.
Twill Intellectual Property
Granted Patents
On October 27, 2020, the United States Patent Office issued Patent No. US 10,813,584 B2 titled ASSESSING ADHERENCE FIDELITY TO BEHAVIORAL INTERVENTIONS USING INTERACTIVITY AND NATURAL LANGUAGE PROCESSING. The abstract contained in the patent award describes this patent as A computer system apparatus and a method carried out by such apparatus for interacting with a user via a behavior intervention designed to cause an increase in emotional well-being of the user. The behavior intervention has a plurality of conditions to be satisfied. The process includes receiving input data from the user during the behavior intervention, performing, on at least a portion of the received input data having text, semantic analysis to identify terms that satisfy the plurality of conditions and assessing, based on an amount of completeness of satisfying the plurality of conditions, a level of adherence to the behavior intervention.
There are also pending associated patent applications filed in the European Patent Office (Application 18835438.5), Canada (Application 3070229), and Hong Kong (Application 620200109481).
On February 7, 2023, the United States Patent Office issued Patent No. US 11,575,737 B2 titled DYNAMIC INTERACTIVE NETWORK SYSTEM FOR PROVIDING ONLINE SERVICE AND SOCIAL COMMUNITY FOR ENGAGING, LEARNING, AND TRAINING SKILLS FOR MENTAL HEALTH. The abstract contained in the patent award describes this patent as A dynamic interactive network system provides an online service and social community for engaging, learning, and training skills for happiness. The system includes a processor and memory storing instructions which when executed by the processor configure the processor to provide the online service. The instructions further configure the processor to provide tracks including activities, provide an initial happiness level and a track to a user based on a self-assessment completed by the user upon signing up, monitor progress of the user based on self-assessments periodically completed by the user, modify the track based on the self-assessments, suggest followers to the user from the users whose profiles match the profile of the user in terms of demographics, psychographics, and rating of the users on the online service, and generate a happiness graph for the user that correlates the activities and the followers with their impact on happiness level of the user.
On February 20, 2024, the United States Patent Office issued Patent No. US 11,909,811 B2 titled DYNAMIC INTERACTIVE NETWORK SYSTEM FOR PROVIDING ONLINE SERVICE AND SOCIAL COMMUNITY FOR ENGAGING, LEARNING, AND TRAINING SKILLS FOR MENTAL HEALTH. This patent is a continuation of Patent No. 11,575,737 with additional claims.
On August 10, 2023, the United States Patent Office issued Patent No. US 11,727,217 B2 titled SYSTEMS AND METHODS FOR DYNAMIC USER INTERACTION FOR IMPROVING MENTAL HEALTH. The abstract contained in the patent award describes this patent as A computing system for interacting with a user comprises a processor and a memory storing executable software which, when executed by the processor, causes the processor to commence an interactive session with a user, receive input data from the user during the interactive session, analyze the received input data and output a response to the user to continue the interactive session with the user. The processor, prior to outputting the response, identifies one or more topics from the received input data, ascertains a tone of the received input data, generates a mirroring prompt based on the ascertained tone of the received input data, and output to the user the generated mirroring prompt. The processor outputs the mirroring prompt to the user during the interactive session to cause an increase in a level of engagement of the user with the interactive session.
On October 10, 2023, the United States Patent Office issued Patent No. US 11,779,270 B2 titled SYSTEMS AND METHODS FOR TRAINING ARTIFICIALLY-INTELLIGENT CLASSIFIER. The abstract contained in the patent award describes the patent as A computing system/method for enabling a user to improve, via training, a system designed to increase the emotional and/or physical well-being of persons or designed for other purposes. The system/method includes retrieving a user response from a dialogue database, the user response having already labeled thereto an assigned class having a highest confidence score, the confidence score indicating degree of confidence that context of the retrieved user response is of the assigned class, displaying, the assigned class, along with other classes each having a respective lower confidence score, and receiving an indication of validity of the assigned class. The system/method further includes retrieving of a pair of sequential user response and follow-up prompt from the database, displaying user-selectable ratings, each rating designating a respectively different quality to the follow-up prompt, receiving selection of a rating and a related comment, and associating the selection and the comment to the follow-up prompt.
There are also pending associated patent applications filed in the European Patent Office (Application 19847959.4), Canada (Application 3109113).
Patent Applications
On October 25, 2021, patent application 17/510,341 was filed in the United States Patent office. Titled DYNAMIC INTERACTION SYSTEM AND METHOD, the abstract for this application describes as A method and system are provided for dynamic user interaction. The method includes assessing input data, received from a user, that is used to determine a psychological state of the user. The method further includes determining a psychological state of the user, using an application stored in non-transitory storage media, based on the input data, and determining possible courses of action for the user based on the determined psychological state of the user. The method additionally includes presenting the psychological state and the possible courses of action to the user through a physical interface.
On December 8, 2021, patent application 17/546,020 was filed in the United States Patent office. Titled CUSTOMIZABLE THERAPY SYSTEM AND PROCESS, the abstract for this application describes as The present invention is directed to a computing system and a process carried out by such system for providing a therapy session personalized to the circumstances of the user. The therapy session includes an audio component that is automatically generated by an algorithm that makes a voice seem to be that of an actual person. In a similar way, a video component to the therapy session may also be presented.
On January 26, 2022, patent application 17/585,003 was filed in the United States Patent office. Titled SENSOR TRACKING BASED PATIENT SOCIAL CONTENT SYSTEM, the abstract for this application describes as A computing system that includes a server, the system functions as a patient social content system (PSCS) which, among other functions, provides content to a patient/user. A device with a network connection to the computing system permits the patient to provide information to the computing system. In addition, one or more sensors are configured to detect changes in various physical parameters relevant to the patient. Electrical signals from the sensors are conveyed to the computing system so that the computing system is aware of changes in physical parameters of the patient. Based on the changed physical parameters of the patient, the computing system provides different content to the user that is relevant to the changes. Overall, processes carried out by the system establish and maintain a patient social content system that utilizes tracking data received from one or more sensors.
On August 1, 2022, patent application 17/878,901 was filed in the United States Patent office. Titled APPARATUS FOR COMPUTER GENERATED DIALOGUE AND TASK-SPECIFIC NESTED FILE ARCHITECTURE THEREOF, the abstract for this application describes as The present disclosure relates to digital devices adapted to increase the efficacy of a computerimplemented migraine treatment plan. In some embodiments, an apparatus generates an interactive session comprising a plurality of tracks and sets a need set according to a baseline level. The need set may comprise a selection of one or more tracks, wherein the selection is a function of the baseline level and/or a variable level. The interactive session may utilize a threetiered architecture interactive dialogue module comprising a master file, a plurality of skeleton files, and a plurality of skin sets, wherein each of the plurality of skin sets is nested within one of the plurality of skeleton files and the plurality of skeleton files are nested within the master file. Accordingly, the tracks, the activities, and the tasks, may each utilize the master file, the skeleton files, and the skin sets, respectively..
Associated applications have been filed in the WIPO (Application No.PCT/US 2022/046487 and EPO (Application No. 22881741.7)
On October 12, 2022, patent application 17/878,901 was filed in the United States Patent office. Titled MODIFIABLE PHARMACEUTICAL PROTOCOL FOR MIGRAINE TREATMENT AND ASSESSMENT OF DRUG EFFICACY THEREOF, the abstract for this application describes as The present disclosure relates to a treatment protocol for the treatment of migraine comprising an abortive drug adapted to bind with a plurality of calcitonin gene-related peptides (CGRP) receptors. The abortive drug may be adapted to mitigate vasodilation in a user. The treatment protocol may comprise evaluating medication-relevant information from a user input to determine positive and/or negative effects of the abortive drug regimen. The treatment protocol may include a preventative drug regimen and a corresponding preventative drug. The treatment protocol may be configured to evaluate the efficacy of the abortive and/or preventive drug regimens based on the determined positive and/or negative effects. In a further embodiment, the drug protocol may be configured to generate suggested alterations to either regimen based on the efficacy evaluation.
On October 12, 2022, patent application 17/964,871 was filed in the United States Patent office. Titled PHARMACEUTICAL ADMINISTRATION TRACKING AND TREATMENT COMPLIANCE SYSTEM’, the abstract for this application describes as The present disclosure relates to a medication tracking and compliance system. In an embodiment, the system receives an initial drug regimen comprising one or more drugs configured to inhibit a calcitonin superfamily of peptides. The system, via a client device, may receive user input and extract the medication-relevant information from said user input. In a further embodiment, the medication-relevant information may be analyzed in view of drug-specific information to evaluate potential positive and/or negative effects. The system may generate an activity within the interactive session, where the activity may be replaced with a succeeding activity based on the activity content efficacy and activity type efficacy of the previously generated activity.
On October 12, 2022, patent application 17/964,874 was filed in the United States Patent office. Titled DISTRIBUTED NETWORK FOR MODIFIABLE INTERACTIVE SESSIONS AND ADHERENCE ENHANCEMENT THEREOF, the abstract for this application describes as The present disclosure relates to a system of networked devices configured to increase the efficacy of a migraine treatment plan and adherence to said treatment plan. The system may comprise a client device and a server, wherein the client device is adapted to generate an interactive session including one or more tracks. In a further embodiment, the client device receives user input and alters the track based on an instant instruction. The instant instruction may be generated by the server based on at least the received input data and the need set. Thus, the server may transmit the instant instruction to the client device, enabling the client device to alter the track such as to improve at least one need from the need set.
On April 19, 2023, patent application 18/136,787 was filed in the United States Patent office. Titled SYSTEMS AND METHODS FOR MANAGING DYNAMIC USER INTERACTIONS WITH ONLINE SERVICES FOR ENHANCING MENTAL HEALTH OF USERS, the abstract for this application describes as A system for conducting dialogues with users of an online service recommending N activities comprises a processor to generate a first file including M portions for conducting the dialogues. The processor generates N second files for the N activities, respectively. The processor includes in each of the N second files references to a plurality of the M portions of the first file. The processor generates a plurality of third files, each corresponding to a task for performing one of the N activities. The processor conducts a dialogue with one of the users about one of the N activities using one of the N second files corresponding to the one of the N activities, a plurality of the M portions of the first file referenced by the one of the N second files, and one of the third files corresponding to a task for performing the one of the N activities.
On August 15, 2023, patent application 18/234,319, a Continuation of application No. 17/671,251, filed on Feb. 14, 2022, now Pat. No. 11,727,217, was filed in the United States Patent office. Titled SYSTEM S AND METH ODS FOR DYNAMIC USER INTERACTION FOR IMPROVING MENTAL HEALTH, the abstract for this application describes as A computing system for interacting with a user comprises a processor and a memory storing executable software which, when executed by the processor, causes the processor to commence an interactive session with a user, receive input data from the user during the interactive session, analyze the received input data and output a response to the user to continue the interactive session with the user. The processor, prior to outputting the response, identifies one or more topics from the received input data, ascertains a tone of the received input data, generates a mirroring prompt based on the ascertained tone of the received input data, and output to the user the generated mirroring prompt. The processor outputs the mirroring prompt to the user during the interactive session to cause an increase in a level of engagement of the user with the interactive session.
Associated applications have been filed in EP (Application No. 21194661.1)
Research and Development Expenses
The company’s research and development expenses included $20,248,000 for the year ended December 31, 2023.
Competition
Certain of the company’s competitors offer this integrated approach in varying degrees, including, among others, Hinge Health, Inc., Livongo Health Inc. (acquired by Teladoc Health Inc.), Omada Health, Inc., Vida Health, Inc. and Virta Health Corp. Customers of the company’s competitors suffer an inadequate user experience, as evidenced by few app store reviews and low scores in Apple, Google and Amazon stores.
Government Regulation
The Dario Blood Glucose Monitoring System is classified as a medical device and subject to regulation by numerous agencies and legislative bodies, including the United States Food and Drug Administration (FDA) and its foreign counterparts.
In September 2013, the company obtained ISO 13485 certification for its quality management system and CE Mark certification to market Dario. In May 2015, Dario was cleared to fulfill the criteria according to EN ISO 15197:2013 The granting of the CE Mark allows Dario to be marketed and sold in 32 countries across Europe, as well as in certain other countries worldwide.
On November 21, 2014, MDSS, the company’s European Authorized Representative, completed the registration of the Dario Blood Glucose Monitoring System with the German Authority as required by Article 10 of Directive 98/79/EC on in vitro diagnostic medical devices.
The company achieved regulatory clearance to market Dario in other countries that do not rely on the CE Mark. As of December 31, 2021, the non-CE Mark jurisdictions, which the company has begun to market Dario include the United States, New Zealand, Canada, and Australia.
History
The company was founded in 2011. It was incorporated in Delaware 2011. The company was formerly known as LabStyle Innovations Corp. and changed its name to DarioHealth Corp. in 2016.
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