Wearable vagus nerve stimulation device with FDA/CE regulatory pathway
Pulsetto makes a wearable neuromodulation device paired with a mobile app targeting stress, anxiety, and sleep disorders. The company is mid-regulatory approval (FDA 510(k) and EU MDR certification in progress) while scaling customer acquisition through paid media—a capital-intensive phase reflected in their hiring focus: 5 of 9 open roles are marketing-focused, concentrated at senior and lead levels. Tech stack is lean (ARM Cortex-M firmware, Bluetooth, AWS backend, Shopify for commerce) with NetSuite adoption signaling shift toward enterprise financial systems as they prepare for volume.
Pulsetto is a medtech and wearables company founded in 2021, headquartered in Vilnius, Lithuania, with 11–50 employees. The product is a non-invasive vagus nerve stimulation (VNS) device designed to reduce stress and improve sleep through neuromodulation. The company operates a direct-to-consumer model (Shopify-based) while pursuing regulatory approval pathways in the US (FDA 510(k)) and Europe (MDR). Current execution focuses on version 3 product launch, paid-media customer acquisition (Google, Meta, Bing, affiliate networks), and regulatory compliance—with active hiring in Lithuania and the United States concentrated in marketing leadership and senior roles.
Pulsetto makes a wearable vagus nerve stimulation (VNS) device paired with a mobile app. It's a non-invasive neuromodulation tool designed to reduce stress and anxiety, improve sleep, and enhance heart rate variability through targeted nerve stimulation.
Pulsetto is actively pursuing FDA 510(k) and EU MDR certification as of the data snapshot. Regulatory approval processes are documented as an active project; certification status should be verified directly with the company.
Pulsetto uses ARM Cortex-M microcontrollers, Bluetooth Low Energy for device connectivity, AWS for backend infrastructure, Shopify for e-commerce, and Microsoft Dynamics 365 for CRM. The company is adopting NetSuite for financial management.