Medical devices & diagnostics · Respiratory remote monitoring
Spire Health
A breathing sensor that sticks to the inside of a patient’s underwear and survives the wash. It started as a consumer calm-tracking gadget, became an FDA-cleared remote monitoring system for COPD, and in September 2024 was folded into another company.
The tag in the waistband
A patient with severe COPD gets a pack of Health Tags in the mail. Each is a small adhesive sensor for the first layer of clothing: a bra, a waistband, a pyjama top. It never needs charging, survives the washer and dryer, and lasts up to twelve months. After that the patient does nothing.
The tag measures the shape of every breath, not a number sampled once a day. Palley called it an ECG for breathing. A dashboard watched seven days a week flags a patient whose respiratory rate has stayed about 10 percent above their own rolling baseline, or pulse 20 percent above, or whose readings cross a hard ceiling of 35 breaths or 135 beats per minute. A clinical liaison then phones within a day or two and asks three questions: more short of breath than usual, more sputum, any change in its color.
Why the form factor is the product
COPD affects roughly 16 million Americans. The expensive part is the exacerbation that lands someone in an emergency department. Caught early, the same episode is often steroids and antibiotics at home.
Spirometers ask a breathless patient to blow hard into a tube. Wristbands need charging. Every extra daily step is a place where adherence goes to die.
A calming lab and a hardware team
Neema Moraveji ran the Calming Technology Lab at Stanford, where his stated quest was to change the way the world breathes. Jonathan Palley was a serial entrepreneur based in Beijing who had sold an education startup and had a hardware and manufacturing team assembled. In 2013 Spire was incorporated with Benjamin Yule as a third founder. The team went through Stanford accelerator StartX, took money from Rock Health and an AngelList syndicate, and had raised about $1.5 million by mid-2014. Y Combinator directory data places the company in the Winter 2015 batch.
From the Stone to the Tag
The first product, the Spire Stone, went on presale in June 2014 at $109. It clipped to a belt or a bra and nudged you to relax. An independent retrospective dates its retirement to 2022.
In February 2019 the company rebranded as Spire Health, hired a chief medical officer, a sales lead and a regulatory lead, and said plainly why: CMS had introduced new remote patient monitoring reimbursement codes for 2019. The consumer business became the training set. Spire said 150,000 units of Stone and Health Tag had been sold, and that this let it train machine learning models on billions of respiratory data points. Reimbursement, not retail, was now the business model.
Cleared, funded, then absorbed
FDA cleared the Spire Health Remote Patient Monitoring System on June 5, 2020. In July 2021 Gilde Healthcare led a $38 million round, and Chris Raanes, already a director, had replaced Palley as chief executive. By early 2024 a third chief executive, Michael Doyle, told Mergermarket the company had raised $70 million, was seeking $35 million more, counted Philips and ResMed among its strategic investors, and was building toward an initial public offering in 2026.
That is not what happened. On September 30, 2024, Wellinks, a New Haven company in virtual cardiopulmonary care, acquired Spire Health in what both sides called a non-cash transaction. Gilde, by then described as Spire’s majority investor, took a board seat. The technology did not disappear: in August 2026 Wellinks announced a $10 million Series B first close with UMass Memorial Health and put the Spire system at the center of its product.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K192952 | Cleared Jun 5, 2020 under 21 CFR 870.2300, Cardiac Monitor, Class II. Primary predicate: Current Health’s wearable monitoring system (K190073). Cleared for longitudinal monitoring of pulse rate, respiratory rate, sleep and wake behavior, and activity, in adults, prescription use. | Public record |
| What the clearance excludes | The label says the system is for general, non-diagnostic sleep and wake monitoring, is not for ICU or operating rooms, is not for acutely ill cardiac patients at risk of life threatening arrhythmias, and is not a substitute for an ECG monitor. No exacerbation prediction claim is cleared. | Public record |
| Testing in the submission | Electrical safety, EMC, biocompatibility, usability, alarms, shipping, wash and dry cycles, shelf life, battery and software all passed. Respiratory rate was validated clinically against end tidal CO2; pulse rate to ISO 80601-2-61. | Public record |
| Hospitalization study, NCT05518981 | Retrospective pre and post cohort at Pulmonary Associates of Richmond, 126 subjects, May 2019 to Feb 2022, registered Aug 29, 2022 after completion. All cause hospitalizations fell 65.0 percent, from 137 to 48. Cardiopulmonary hospitalizations fell 63.6 percent. Sensor adherence averaged 88.6 percent of days. | Public record |
| What that study cannot show | The authors list the limits: no randomization, no contemporaneous control, selection and survivorship bias, COVID era effects, possible regression to the mean. Four of six authors were Spire employees and a fifth received financial support from the company. | Public record |
| Escalation study, 2024 | Retrospective review of 245 outpatient visits from 168 patients seen within 7 days of a monitoring escalation. 84.1 percent produced a clinical intervention, 66.5 percent treatment consistent with a COPD exacerbation, 1.6 percent an emergency department referral. | Public record |
| Patents | Six granted US patents assigned to Spire, Inc., from the February 2014 application through number 12376792, granted Aug 5, 2025, after the acquisition. | Public record |
| Reimbursement | The business runs on Medicare codes 99453, 99454, 99457 and 99458. Federal rules require an established patient relationship, data on at least 16 of 30 days for 99454, and a device meeting the FDA definition of a medical device. | Public record |
| “FDA approved” language | A customer practice page calls Spire “an FDA approved continuous respiratory monitoring device.” The record is a 510(k) clearance, a finding of substantial equivalence, not an approval. | Differs from the record |
| Federal grant claim | Company boilerplate from 2019 to 2022 says Spire “has received a grant from the US Department of Health and Human Services.” No matching NIH or NSF award was found in federal award records. | Not found |
| Scale | “To date our sensors have been worn by more than 150,000 people.” The same figure was used in 2019 for combined unit sales of the consumer Stone and the Health Tag. | Company-stated |
Read plainly: the hardware claim is the strong one. The sensor is cleared, it was validated against end tidal CO2, and it holds adherence near 90 percent in old and sick patients for a year. The outcomes claim is weaker than the marketing. A 65 percent drop in hospitalizations is a large number from a 126 patient study with no control group, written mostly by employees. The prediction claim, up to seven days before symptoms, sits outside the cleared indications entirely.
What to watch
- Whether Wellinks publishes a controlled study rather than another pre and post chart review.
- Any new 510(k). Predicting deterioration would need its own clearance.
- CMS rulemaking on remote physiologic monitoring, the revenue line under the whole model.
In their words
“give people the awareness and control over their state of mind, and breathing is the simplest way to do it because it’s very measurable and actionable while the mind is amorphous.”
Neema Moraveji, co-founder, to TechCrunch, 2014 · Independent
“You’ve got a population that is sick, elderly and not very tech savvy.”
Jonathan Palley, co-founder and CEO, to Fierce Biotech, 2019 · Independent
“Think of it kind of like an ECG for breathing.”
Jonathan Palley, to Fierce Biotech, 2019 · Independent
“When you ask a patient to do something, particularly every day at home, he/she is very unlikely to do that, especially for a long period of time.”
Jonathan Palley, Research2Guidance interview, 2019 · Interview
“Health Tag has no direct competitors.”
Jonathan Palley, Research2Guidance interview, 2019 · Interview
“COPD remains an area of high unmet need where patients often struggle to manage their disease and providers feel disconnected from their patients.”
Geoff Pardo, General Partner, Gilde Healthcare, funding release, 2021 · Investor, company release
“Wellinks will now be able to passively monitor cardiopulmonary patients while leveraging machine learning to predict potential complications, often before the patient experiences symptoms.”
Stacie Bratcher, CEO of Wellinks, acquisition release, 2024 · Company release
Related companies
Sources
- Public recordFDA 510(k) clearance letter and summary, K192952
- Public recordClinicalTrials.gov NCT05518981
- Public recordUse of Remote Cardiorespiratory Monitoring is Associated with a Reduction in Hospitalizations for Subjects with COPD
- Public recordClinical Interventions Following Escalations from a Continuous Respiratory Monitoring Service
- Public recordEarly Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring
- Public recordUS patents assigned to Spire, Inc.
- Public recordForm D filings, Spire, Inc., CIK 0001810534
- Public recordBilling for remote patient monitoring, CPT 99453, 99454, 99457, 99458
- IndependentSpire Health launches COPD study with its machine-washable wearable
- IndependentMeet “Spire”, The Wearable Breath Tracker That Calms You Down
- IndependentStudy aims to identify digital predictors of COPD exacerbations
- InterviewInterview with Jonathan Palley, Spire Health co-founder and CEO
- IndependentNew Haven-based digital healthcare firm Wellinks acquires San Francisco tech company
- IndependentWellinks Acquires Spire Health, Launching Predictive Patient Care
- IndependentWhat happened to the Spire Stone?
- CompanySpire is now Spire Health, announces focus on remote patient monitoring
- CompanySpire Health closes $38 million financing round led by Gilde Healthcare
- CompanySpire CEO Michael Doyle talks to Mergermarket
- CompanyWellinks acquires Spire Health
- CompanyWellinks closed $10 million Series B funding
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
