Makani Science

Executive Summary

Makani Science is a San Francisco-based medical device company developing a wearable, wireless, and noninvasive breathing sensor designed to continuously monitor key pulmonary function parameters—including respiratory rate, tidal volume, and minute ventilation. Founded in 2018, the company addresses a critical gap in patient monitoring: outpatient and post-operative settings where traditional tethered spirometry is impractical. By enabling real-time respiratory tracking, the device aims to reduce adverse events such as opioid-induced respiratory depression and improve overall patient safety. Makani's technology could potentially replace intermittent spot-checks with continuous data, offering clinicians earlier warnings and better informed interventions, especially in home care or step-down units. While the company is still in early stages with no disclosed funding rounds or regulatory approvals, the device's clear clinical need and the growing trend toward remote patient monitoring position it well for future adoption. The key challenge will be navigating FDA clearance, establishing clinical evidence, and competing with other respiratory monitoring solutions. If successful, Makani Science could capture a significant niche in the wearable health monitoring market, which is expected to grow rapidly over the next decade.

Upcoming Catalysts (preview)

• Q4 2026FDA 510(k) clearance or De Novo classification for the breathing sensor50% success
• Q2 2026Publication of clinical validation study results in peer-reviewed journal45% success
• Q3 2026Strategic partnership or licensing deal with a large hospital system or monitoring company35% success