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Systems/Spira

Clinical-grade spirometry, in hand.

Spira is a handheld pulmonary function instrument measuring FEV1, FVC, FEV1/FVC, and peak expiratory flow against ATS/ERS criteria, with a learned per-user baseline and early anomaly detection.

4
Core metrics — FEV1 · FVC · ratio · PEF
150 mm
Instrument length × 45 mm body
16,596
NHANES reference subjects
510(k)
Target regulatory pathway
The Problem

Respiratory disease is the third leading cause of death. Spirometry is still confined to clinics.

Lung-function testing today produces isolated readings, separated by months, interpreted without personal context. Decline between visits — the clinically decisive interval — goes unmeasured.

For COPD and asthma patients, that gap is where exacerbations form. Spira is designed to close it: a clinical-grade maneuver at home, every day, scored against the patient's own baseline rather than a population average alone.

Spira — engineering render
Instrument

Specification.

Form factorHandheld tapered cylinder, 150 × 45 mm, two-part SLS nylon housing
Flow sensingHoneywell HSCDANN005PG2A3 differential pressure sensor with auxiliary flow sensor
ComputeESP32-S3 class microcontroller, Bluetooth Low Energy
Display30 × 12 mm OLED, single tactile control
Power18650 lithium-ion, 3000 mAh, USB-C charging
HygieneReplaceable TPU mouthpiece, bayonet twist-lock
Pipeline

A baseline that belongs to the patient.

01

Maneuver capture

Forced expiratory maneuver measured by differential pressure; acceptability and repeatability assessed against ATS/ERS criteria.

02

Baseline modeling

Per-user reference adjusted for age, sex, height, and BMI — trained against NHANES 2007–2012 (16,596 subjects) and 37,000+ categorized respiratory records.

03

Anomaly detection

Real-time deviation scoring against the personal baseline; classification into Normal, Borderline, or Alert with longitudinal trend analysis.

04

Clinical handoff

Results stream to Plexus as FHIR observations, available to the patient's clinician through standard interfaces.

Development Status

Where the program stands.

CompleteSoftware prototype — firmware, analysis pipeline, display interface. CAD hardware design. Production code audit.
In progressClinical advisory outreach: pulmonologists, respiratory therapists, and pulmonary function laboratory directors.
NextBench comparison against a clinical reference spirometer, followed by structured clinician feedback and an IRB-approved validation study.
PathwayFDA 510(k); ISO 13485 quality management planned for manufacture.

All systems →    Discuss the program →

All device programs are pre-clinical prototype and concept work. No MSTFA instrument is FDA cleared, CE marked, or available for clinical use.