Medical devices & diagnostics · Heart failure monitoring
Bodyport
A bathroom scale that reads hemodynamic signals through bare feet. Cleared by the FDA in 2022 and validated in a 329 patient study run out of Duke, it still lacks the trial that would show it keeps anyone out of hospital.
Twenty seconds, barefoot
In April 2015, in a room in Mountain View, a biomedical engineer stepped onto a prototype that looked like an ordinary bathroom scale. He was ten minutes into a Y Combinator interview. The device read his heart rate off the soles of his feet and put the number on a screen.
The investor running the interview noticed what it said. “He was nervous, and we could tell since his pulse was in the low 100’s.”
That is the product in miniature: an object people already own, quietly taking a cardiac measurement. Eleven years on it has a 510(k) number, a validation study, two trials recruiting, and an unresolved question about outcomes.
Why weight is a late signal
Roughly 6 million US adults live with heart failure. Bodyport’s own figures have put the annual burden at 1 million hospitalizations and nearly $35 billion in 2020, and 1.2 million hospitalizations and $30.7 billion in 2022, with more than 90 percent of admissions traced to fluid building up in the body.
The standard noninvasive defense is a scale and a rule of thumb: call the clinic if you gain 3 pounds in a day or 5 pounds in a week. It is cheap, it is in the guidelines, and it fires late. The SCALE-HF 1 paper says so plainly: weight change is usually a late sign of decompensation, and weight monitoring has never been shown to reduce hospitalization risk.
The alternative that works is invasive. Implanted pulmonary artery pressure sensors have cut admissions in trials, but they need a procedure, a narrow indication and a large budget, so most patients never get one. Bodyport’s wager is that enough of the signal can be pulled from two bare feet standing still for twenty seconds.
The engineers who had already sold one cardiac device
Corey Centen and Sarah Smith are biomedical engineers who had done this before. Their first company, Atreo Medical, built a device that coached rescuers through chest compressions during CPR. Medtronic bought it.
“We wanted to bridge the gap between typical digital health tools and the more advanced medical devices that exist in a hospital setting,” Centen told MedCity News in 2020. “It’s been an interesting journey moving from the reactive side to the preventive side.”
They went through Y Combinator in the summer of 2015 and were funded again at seed by Initialized. In August 2020 the Boehringer Ingelheim Venture Fund led an $11.2 million Series A with Playground Global and Initialized, taking reported total funding to $15.8 million. A research collaboration with Brigham and Women’s Hospital was announced the same morning.
Clearance, and the algorithm that kept changing its name
The FDA cleared the Bodyport Cardiac Scale on July 29, 2022, as K211585, a class II impedance plethysmograph. Read the record closely and the clearance covers four measurements: “body weight, peripheral impedance, pulse rate, and center of pressure” in patients with fluid management related conditions.
Those four are the inputs. The product is the algorithm on top of them, and that algorithm has been renamed twice in public. In 2022 the company called it the Bodyport Fluid Index. In May 2023 it became the Heart Function Index, and phase 2 of the study programme “will focus on the validation of the HFI algorithm and provide the pivotal data Bodyport needs for FDA clearance of the HFI.” By March 2024 the published result concerned something called the Congestion Index, which the company now describes as a “clinical decision support tool” rather than a cleared device.
Leadership turned over on the same schedule. John Lipman, a commercial operator from Quanta Dialysis Technologies and NightBalance, became CEO in June 2022. Centen moved to president and CTO, Smith later to chief product officer.
The number that made people look
SCALE-HF 1 enrolled 329 patients at eight US sites between July 2021 and June 2022, followed them for 238 participant years, and produced 69 usable heart failure events. Duke Clinical Research Institute coordinated it. Bodyport funded it.
The Congestion Index flagged 48 of those 69 events within 30 days, a sensitivity of 0.70, at 2.58 alerts per participant year. The weight rule caught 24 of 69, a sensitivity of 0.35, at 4.18 alerts. Twice the detection, roughly 38 percent fewer alerts. Then read the limitation the authors wrote themselves: clinicians were blinded to the scale data throughout, and “the impact of clinician intervention was not tested in this study.”
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K211585 | Received May 24, 2021, decided Substantially Equivalent Jul 29, 2022. Product code DSB, class II, applicant Bodyport, Inc. The only 510(k) in the FDA database under that applicant. | Public record |
| What is cleared | Four measurements: body weight, peripheral impedance, pulse rate and center of pressure. Company materials describe a scale that measures “cardiac output, congestion, heart rate, and other leading indicators of cardiovascular health.” Stroke volume and ballistocardiography are research signals, not cleared claims. | Claim exceeds the clearance |
| Congestion Index | Marketed as a clinical decision support tool built from a subset of the cleared biomarkers. Not itself a cleared device, and no second Bodyport 510(k) exists as of Sep 22, 2026. | Public record |
| SCALE-HF 1 result | Journal of Cardiac Failure, online Sep 16, 2024. Sensitivity 0.70 against 0.35 for the weight rule, specificity 0.80, 2.58 against 4.18 alerts per participant year. Sponsor funded, DCRI coordinated. | Public record |
| What it did not test | Investigators and treating clinicians were blinded to scale data and no attempt was made to influence practice. The paper states the impact of clinician intervention was not tested. | Public record |
| SCALE-HF 2 | Named in 2023 as the source of pivotal data for clearance of the index, and in 2024 as in development. No record of it on ClinicalTrials.gov as of Sep 22, 2026. | Not found |
| Trials now running | FIGHT-HF at the Cleveland Clinic (NCT07205120), interventional, 50 patients, started Oct 8, 2025. SCALE-PD in peritoneal dialysis (NCT07059962), observational, 125 patients, started Sep 9, 2025. Both recruiting. | Public record |
| Published literature | Six PubMed indexed papers involving the device, from a 2021 Fick method comparison in JAHA to a Feb 2026 American Heart Journal paper on phase angle and hospitalization risk. | Public record |
| Health system use | Geisinger announced a 12 month pilot in Aug 2023 covering about 200 patients, building on an earlier 100 patient study. No published result since. | Partner-stated |
| Still operating | FDA establishment registration 3020885267 active with a 2026 expiry year in San Francisco. Press page updated Jan 21, 2026, and a real world outcomes deck was presented at THT 2026 on Mar 4, 2026. | Public record |
Read plainly: the hardware is cleared, the biomarkers are validated in peer reviewed work, and the prediction claim has survived a multicenter study with an academic coordinating center. The last link is missing. Nobody has shown that acting on a Congestion Index alert changes what happens to a patient, and neither study now recruiting is the outcomes trial Bodyport’s own investigators keep naming as the one that matters.
What to watch
- FIGHT-HF at the Cleveland Clinic. Primary completion was estimated for March 2026 and no result has been posted.
- Whether SCALE-HF 2 is ever registered. It has been called in development since 2024.
- A second 510(k), which the company said in 2023 was the point of phase 2.
- SCALE-PD results, estimated for June 2026, which would open kidney care as a second market.
- Any named paying customer. Six years after the Series A, none has been disclosed.
In their words
“He was nervous, and we could tell since his pulse was in the low 100’s.”
Garry Tan, Initialized Capital, on the 2015 YC interview, 2020 · Investor
“We wanted to bridge the gap between typical digital health tools and the more advanced medical devices that exist in a hospital setting.”
Corey Centen, co-founder, MedCity News, 2020 · Independent
“It’s just powered off of four AA batteries, and it’s cellular connected so there’s no need for the patient to have a smartphone or home WiFi.”
Sarah Smith, co-founder, MedCity News, 2023 · Independent
“Patients with heart failure and their caregivers have few options outside of a standard weight scale or a costly and invasive implant.”
John Lipman, CEO, August 2022 clearance release · Company release
“Late signals, like weight gain, are still very reliable, but if you rely of weight gain and symptoms, you’re going to be late to the game.”
Marat Fudim, Duke University, to TCTMD, 2024 · Independent
“In a perfect world, the next study after that would be SCALE-HF 3, which would be an outcomes study.”
Marat Fudim, lead investigator, to TCTMD, 2024 · Independent
“This technology took a common tool that we have used in clinical care for decades, a bathroom scale, and improved it to the point that we can better predict worsening heart events.”
Adam DeVore, Duke University School of Medicine, September 2024 release · Company release
Related companies
Sources
- Public recordFDA 510(k) K211585, Bodyport Cardiac Scale
- Public recordopenFDA establishment registration 3020885267
- Public recordClinicalTrials.gov NCT04882449, SCALE-HF 1
- Public recordClinicalTrials.gov NCT07205120, FIGHT-HF
- Public recordClinicalTrials.gov NCT07059962, SCALE-PD
- Public recordResults From SCALE-HF 1
- Public recordBioimpedance phase angle and hospitalization risk
- IndependentBodyport raises $11.2M, collaborates with Brigham and Women’s
- IndependentBodyport receives FDA 510(k) for connected scale
- IndependentSmart Scale Better at Predicting HF Events
- IndependentGeisinger launches monitoring with Bodyport’s scale
- IndependentFirst Reported Real-World Outcomes, THT 2026 deck
- InvestorBodyport Collects Lifesaving Data
- CompanyBodyport Raises $11.2 Million in Series A Funding
- CompanyBodyport Receives FDA Clearance for the Cardiac Scale
- CompanyStudy to Measure Accuracy of Unique Index
- CompanyBodyport website and research pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
