Regulatory Milestone
September 30, 2026
Dandelion Medical Devices Announces FDA 510(k) Submission Number for PulseTape ECG™
Dandelion Medical Devices, Inc. today announced that the U.S. Food and Drug Administration has assigned K263281 to the company's 510(k) premarket notification for PulseTape ECG™.
The submission represents Dandelion's first FDA premarket notification and an important regulatory milestone in the development of the company's PulseTape™ platform.
PulseTape ECG™ is a wearable, wireless sensor designed to collect physiological data for review by healthcare providers.
Assignment of K263281 identifies Dandelion's submission within the FDA 510(k) review process. It does not constitute FDA clearance or approval of PulseTape ECG™.
Dandelion does not comment on the substance or status of active regulatory reviews.
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Industry Showcase
February 2026
PulseTape ECG™ Selected for Nordic Semiconductor’s CES Healthcare Showcase
PulseTape ECG was selected to be featured in Nordic Semiconductor’s Healthcare Products section at CES, as reported in the American Heart Association’s February 2026 newsletter.
The showcase highlighted Dandelion Medical Devices’ wearable ECG technology and its lightweight, tape-style design for continuous heart rhythm recording.
In the News
January 19, 2026
Nordic Semiconductor Spotlights PulseTape ECG™
Nordic Semiconductor featured PulseTape ECG in an article exploring the technology behind the wearable and its development with engineering support from Cloud2GND.
The feature examines the device’s compact design and Bluetooth connectivity for transferring ECG data to compatible devices for clinician review.
Company Milestone
August 2025
Dandelion Medical Devices Joins the American Heart Association’s Innovators’ Network
Dandelion Medical Devices is a member of the American Heart Association’s Innovators’ Network. The Association welcomed DMD in its August 2025 newsletter.
The network brings together entrepreneurs, healthcare providers, researchers, health systems, and other organizations working to advance digital health innovation.