Health & Fitness

Revolutionizing At-Home Heart Monitoring With an FDA-approved Wearable and Mobile App Draws an Elect

Wearlinq

Background

Wearlinq was founded to provide higher diagnostic yield for healthcare providers via 24/7 ECG recordings while empowering patients to better understand and track their heart’s health. As their trusted technical partner, Swenson He has assisted Wearlinq from conception, initial launch, FDA submission, and full market launch.

Challenge

Challenge

Wearlinq set out to revolutionize the heart healthcare industry through the creation of a small, comfortable and accurate long-term wear ECG monitor, eWave, and mobile app companion. The mobile app empowers users with personalized insights based on their unique ECG data to help them learn more about their heart health and even connect with physicians – all from the comfort of their own home.

Our Solution

To create a companion app that provides instant interpretation of a user’s symptoms, Swenson He partnered closely with the eWave firmware technology team. As we planned and developed the technical architecture, our engineers tackled every decision as an individual problem, with a sheer focus on intelligent design, precision, and efficiency. This provided collaborative and detailed technical specifications for the use of further firmware development and mobile application.

Focused on realizing Wearlinq’s vision, Swenson He kept the user experience at the center of our proven processes. We utilized user, competitive, and market research to help guide the user experience while keeping in mind the complex and serious nature of the healthcare application. 

Swenson He utilized our deep understanding of agile development to ensure that all Wearlinq workstreams (architecture, strategy, design, firmware development, app development, QA, and FDA documentation) were working in a way to maximize efficiency. Detailed plans and timelines were created to help ensure various work streams did not create blockers for one another.

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Focused on realizing Wearlinq’s vision, Swenson He kept the user experience at the center of our proven processes. We utilized user, competitive, and market research to help guide the user experience while keeping in mind the complex and serious nature of the healthcare application.

Swenson He utilized our deep understanding of agile development to ensure that all Wearlinq workstreams (architecture, strategy, design, firmware development, app development, QA, and FDA documentation) were working in a way to maximize efficiency. Detailed plans and timelines were created to help ensure various work streams did not create blockers for one another.

We Delivered.

101

participants in the test study

$1M+

raised

FDA

Approved
"
"

By ensuring the user experience contained the same high level of quality and sophistication as the technical architecture we were able to create a cutting-edge, easy-to-use experience that allows users to keep a pulse on their heart’s health.

From product requirements to UI and technical decisions, compliance with FDA and HIPAA requirements were two of our guiding principles. The Swenson He team created over 100 pages of detailed product and technical documentation outlining requirements, risks, and rationale in accordance with FDA regulations. All resulting inSo that we could submit for 510(k) FDA approval.

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Los Angeles, CA
407 N Maple Drive, Ground 1
Beverly Hills, CA  90210
Dallas, TX
17250 Dallas Pkwy
Dallas, TX 75248
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