Medical devices & diagnostics · Respiratory monitoring
Makani Science
A bandage-sized strain sensor that reads breathing off the chest and the belly. The FDA cleared it in March 2025 for adults lying still in a procedure room or a dental chair. The company that makes it has three employees and ended 2025 with $312,123 in the bank.
Four minutes
The company opened its 2022 crowdfunding pitch with a clock. “After you stop breathing, it only takes 4 minutes for permanent brain damage to start.” Everything it has built follows from that sentence, and from a second one: on most hospital wards, nobody is watching.
Breathing is counted by hand, or inferred from a pulse oximeter that reports oxygen rather than air, or measured by capnography through a nasal tube that slips. Makani’s answer is two adhesive patches, on the thorax and the abdomen, wired to nothing. Each holds a wrinkled platinum strain gauge whose resistance changes as the torso expands, and Bluetooth carries the signal to an iPad that draws the breath as a waveform.
The sensor came out of a craft supply. The Khine lab at UC Irvine shrinks polystyrene sheets, the kind sold as Shrinky Dinks, to crumple a sputtered metal film into a microscopic accordion. A 2016 paper in Nanoscale reported a gauge factor of 42 across a 185 percent strain range, and a 2019 paper in npj Digital Medicine put it on a torso against a clinical spirometer.
A NICU, and a lung nobody was watching
Michelle Khine is a professor of biomedical engineering at UC Irvine who has co-founded Fluxion Biosciences, Novoheart and Vena Vitals. Her newborn son lay in the NICU covered in leads while a collapsed lung went undetected for hours. None of the monitors on him watched his breathing.
She built the company with Michael Chu, a doctoral student in her lab whose dissertation became the product. They incorporated in Delaware on March 26, 2018. Koa Accel, an Orange County accelerator run by Francis Duhay, put in the first money in 2019. Y Combinator took them into its Summer 2021 batch, where the promise was that Makani “will be FDA cleared in our beachhead market within a year.” Clearance arrived four years later.
Greg Buchert, a former pediatric emergency physician who had led an angel group’s due diligence on the company, joined the board in 2020 and became chief executive in 2023.
What the clearance actually says
K233953 is a Class II breathing frequency monitor cleared against PMD Solutions’ RespiraSense. The FDA received the file in December 2023 and decided in March 2025. Buchert told the Orange County Business Journal that changed agency standards forced the company to repeat its clinical work and meet new cybersecurity rules.
The cleared labeling is narrow. It covers adults aged 22 or older, in healthcare facilities and dental offices, supine or semi-recumbent. It reports respiratory rate, not volume. And it says, in plain type, “It is not intended to be used as an apnea monitor.” The public story around the company runs wider than that.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K233953 | Received Dec 15, 2023, cleared Mar 28, 2025. Class II, 21 CFR 868.2375, code BZQ. Predicate: PMD Solutions RespiraSense, K220111. Two single-patient sensors, up to 24 hours, accuracy plus or minus 3 breaths per minute. Contract manufacturer: Wistron Medical Technology, Taiwan. | Public record |
| Clinical testing in the file | 29 subjects, against manually counted end-tidal CO2, in four postures, with subgroups by sex, BMI, skin type and comorbidity. | Public record |
| NCT06521385, Makani-004 | 32 enrolled, May to Jul 2024, one site in Fullerton. Results posted Mar 16, 2026: mean absolute error 0.63 breaths per minute against capnography, 95 percent interval 0.49 to 0.80. Left side 1.49, reclined 1.38, both inside the threshold. | Public record |
| NCT06000852, Makani-002 | The pivotal protocol, 27 enrolled Aug to Oct 2022. Results posted Mar 25, 2026: root mean square percentage error against manual counting of 22.9 percent supine and 25.0 percent reclined. This is the study FDA lists, and the one that was repeated in 2024. | Public record |
| NIH award | R61HL177500 from NHLBI, PI Michael Chu, for classifying apnea of prematurity. $371,021 in FY2025 and $362,934 in FY2026, running to Feb 2027. The company calls it a $1.1 million grant, the full award rather than what is obligated. | Public record |
| Peer-reviewed basis | Nanoscale, 2016, and npj Digital Medicine, 2019, both under UC Irvine affiliations. No PubMed-indexed paper under the company name, and neither trial has been published. | Public record |
| Motion and ambulatory use | UC Irvine articles say the patch works “even while in motion.” The cleared device is labeled for non-ambulatory use. That claim rests on the 2019 research, not the clearance. | Differs from the label |
| Volume measurement | The company describes rate, tidal volume and minute ventilation. The cleared system reports rate only. Volume is the second-generation goal NIH is funding. | Differs from the label |
| Commercial timing | In May 2025 the company was reported to be preparing a launch by the end of that year. Its SEC annual report of Apr 29, 2026 says it will file a second-generation 510(k) by the end of 2027 and commercialize in the second half of 2028. | Differs from the filing |
| NSF funding | No National Science Foundation award to Makani Science was found. Every award surfaced by a name search belongs elsewhere. | Not found |
Read plainly: the device performs about as well as its label promises, and the label is modest. The 2024 study puts the error well under one breath per minute against capnography in still patients, with the numbers on a public registry. What has not happened is the part everyone is waiting for: a sensor on moving patients, in a crib or at home, reporting volume as well as rate. That version is funded, and by the company’s own filing it is three years from market.
What to watch
- Whether the $5 million pre-Series A named in the April 2026 annual report closes. That filing says cash covered operations only to the end of June 2026.
- The second-generation 510(k), promised by the end of 2027, which would add volume and infant use.
- Whether the $111,059 booked in 2025, the first revenue the company ever recorded, repeats.
In their words
“I believe this device could transform how we think about respiratory care.”
Greg Buchert, CEO, UCI Beall Applied Innovation, 2025 · Independent
“Under routine conditions, a five- to twelve-second lead time over existing monitors might not seem like much. But when someone is deteriorating? That’s huge,”
Greg Buchert, UCI Beall Applied Innovation, 2025 · Independent
“It shows that our device not only works as we say it does, but it shows that it’s safe, it’s accurate and at least equal to the current devices that are on the market,”
Greg Buchert to the Orange County Business Journal, May 2025 · Independent
“There are continuous respiration monitors, but they don’t work well during motion,”
Greg Buchert to the Orange County Business Journal, May 2025 · Independent
“Additionally, we also show that the system is capable of detecting respiration under various ambulatory conditions.”
Chu and colleagues, npj Digital Medicine, 2019 · Peer reviewed
“Current cash balance will allow us to operate until end of June of 2026. We are in the process of raising a $5M Pre-Series A round of funding which will last us through Q2 2028.”
Makani Science Inc., SEC Form C-AR annual report, Apr 2026 · SEC filing
Related companies
Sources
- Public recordFDA 510(k) clearance letter and summary, K233953
- Public recordClinicalTrials.gov NCT06521385 with posted results
- Public recordClinicalTrials.gov NCT06000852 with posted results
- Public recordNIH RePORTER, project R61HL177500
- Public recordSEC Forms C, C-U and C-AR, including the annual report exhibit for 2025
- Peer reviewedRespiration rate and volume measurements using wearable strain sensors
- IndependentIrvine Startup Introduces Bandage-Sized Respiratory Monitor
- IndependentFDA Clears Makani Science’s Bandage-Sized Respiratory Monitor
- IndependentBreathing Room
- CompanyMakani Science Receives FDA Clearance for Groundbreaking Respiratory Monitor
- CompanyCompany site, home and product pages
- CompanyRegulation Crowdfunding offering page
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
