01 / 07Heart failure
Heart failure Prescribed today under the existing clearance · Heartbeat Clarity under study

For the patients you send home with a weakening heart.

The XK300 Essence can be prescribed for a heart-failure patient today, under its existing clearance for heart rate and breathing rate. Nothing worn, nothing charged, nothing to remember. Six thousand readings a night, every night, for months or years, read by your team. Alongside the cleared vitals, Heartbeat Clarity is shown as information: an investigational measure now in a study with four cardiology programmes.

Why it keeps coming back

Heart failure is not an event. It is a spiral that tightens.

Each admission leaves the heart weaker and the next interval shorter, and most patients go home with no continuous monitoring at all.

1 in 4back within 30 daysReadmission ranges as reported internationally
1 in 2back within six monthsLocal rates vary; the shape does not
About halfdie within five years of diagnosisPublished survival figures
1 in 10has continuous monitoring: an implantThe other nine go home with a bathroom scale. XK estimate from implant volumes.

Readmission and survival figures as reported internationally; local rates vary, the shape does not. Monitoring share is an XK estimate from implant volumes.

What patients are given today Categories, not brands

Between a bathroom scale and an implant, nothing stayed.

Everything a discharged heart-failure patient is handed today asks something of them: a routine, a charger, a patch change, or a procedure. The record stops when the routine does.

Bathroom scale
Reactive

Scale and blood-pressure cuff

Same time every morning, if it happens. Easy to skip, and weight moves only after fluid has already built up.

Smartwatch
Dies in days

Smartwatch

Prescribed by some cardiology programmes today. A watch needs charging; patients come back after thirty days with a few days of data and a dead watch.

Adhesive wearable patch
About five days

Adhesive patch

The common choice in US hospitals after discharge. Wearable ECG and vitals for roughly five days per patch, then it is replaced or the record ends. Skin, adhesive, a return kit, and someone to apply the next one.

Pulmonary-artery pressure sensor
Severe only

Pulmonary-artery implant

A procedure, and a cost that reserves it for the most severe. Out of reach for nine in ten.

XK300 Essence
The missing tier

XK300 Essence, at home

On the wall or under the mattress, prescribed before discharge. Nothing to wear, charge or apply. Heart rate, breathing rate and breathing pattern every few seconds, all night, for months or years, and your team watches the record.

Scale and cuffSmartwatchAdhesive patchImplantXK300 Essence
What it asks of the patientA morning routine, every day.Wearing it, and charging it.Skin and adhesive; a new patch when the old one is done.A procedure.Nothing. It reads through bedding, from the wall or under the mattress.
How long the record lastsAs long as the routine.A few days per charge.About five days per patch.Years.Months to years, every night.
What it readsWeight; blood pressure.Pulse; activity.ECG, heart rate, breathing, activity while worn.Pulmonary-artery pressure.Resting heart rate, breathing rate and breathing pattern; bed presence and movement. Heartbeat Clarity, shown as information.
When it readsOnce a day.While worn and charged.Continuously, until the patch is done.On demand, daily.Every few seconds, whenever the patient is at rest in bed.
Who watchesThe patient, then a nurse call.The patient's phone.A monitoring service, for the life of the patch.The cardiology team.Your team, in the dashboard or through the API, for as long as it is deployed.
Cleared forWeight; blood pressure.Varies by device.ECG and vitals while worn.Pulmonary-artery pressure in selected heart-failure patients.Heart rate and breathing rate in adults (510(k) K202464). Not a heart-failure test.

Categories described as commonly deployed; no product is named. The XK300 family is cleared to measure heart rate and breathing rate in adults. It does not diagnose heart failure and is not an alarm system.

Heartbeat Clarity Investigational · not a cleared measurement · study in progress

Not how fast. How clearly.

Radar reads the heartbeat as chest-wall motion, so it can score how strongly the heart moves and how regularly it beats. Heartbeat Clarity is the share of confirmed-rest moments in which each beat resolves cleanly. It falls when the pump weakens or the rhythm breaks: the two things heart failure does.

Live, illustrative. Left: intensity, how much the chest wall moves with each beat. Right: rhythm, how evenly the beats arrive. Heart failure weakens the motion; atrial fibrillation scrambles the rhythm. Either one pulls Heartbeat Clarity down.

Intensity: how strongly the heart moves

A weakening left ventricle moves the chest wall less. The radar senses the beat shrink.

Rhythm: how regular the beat is

A healthy heart is metronomic. Atrial fibrillation is random, beat to beat. The measure rewards consistency, not speed.

An ambient measure

No electrode, no wearable, no test ordered. The signature appears in passive, continuous monitoring, while the patient simply rests in bed.

The metric Stillness is not enough

Breathing resolves easily, so it confirms the person was at rest. Whether the heartbeat also resolves in those moments depends on how strong and how regular it is.

Clear signal · regular rhythm
HBC ≈ 0.92

Every rest reading resolves a beat. Healthy example value, illustrative.

Confirmed heart failure · 28 of 28
HBC ≈ 0.1

Every one of the 28 residents with confirmed heart failure in our care-setting record sat at about 0.1, with the sensor correctly installed. Not most. All of them.

The formula

Heartbeat Clarity = resolved heartbeat samples ÷ resolved respiration samples, over a full day.

A detection yield, not a heart rate. A count of successful readings, not beats per minute.

Why it falls

Denominator holds. Detected breathing means the body was still, so respiration keeps logging.

Numerator drops. Heart failure and arrhythmia break the periodicity the beat detector relies on; beats go unresolved and the ratio falls.

28 of 28confirmed heart-failure patientshad Heartbeat Clarity of 0.10 or lower
1,832people at 0.10 or loweracross 49,000 monitored in care settings
April 2026first documentedduring a US acute-care data review

Honestly stated: only 28 confirmed events. Heart failure is diagnosed in hospital and rarely reaches the nursing-home record; the cardiology study closes exactly that gap. Heartbeat Clarity is shown as information alongside the cleared vitals. It is not a cleared heart-failure test, and XK does not predict or diagnose health events.

Films
What the record showed Retrospective · discovery and research · not a claim

Seen afterwards, the readings had moved days before the event was documented.

How to read this

A look back at records from care settings where the clinical XK300 was in use, part of an ongoing discovery and research programme. "Days before" is the interval between a shift in a person's own readings and the date the event was recorded, averaged across events and measured after the fact. It is not a claim that any Kardian product detects, predicts or diagnoses heart failure, and no such use is cleared.

28documented events
73.2%pattern matchedon data the model had not seen
5.3 daysbefore the eventaverage, in review
What moved, in order February 2026 analysis
  1. Heartbeat Clarity starts to fall.The heartbeat pattern gets harder to read cleanly, before any number is out of range.
  2. The baseline change is visible.On average 5.3 days before the event was documented, in retrospective review.
  3. Breathing lifts, and stays up at night.Each breath becomes harder work.
  4. Resting heart rate climbs.Still inside the printed reference range. Not usual for this person.
  5. Heartbeat Clarity reaches 0.1 or lower.In all 28 documented events, it had fallen to 0.1 or below before the event.

Replay it against the other conditions in the care-setting record, or read the full table on the science page.

Prescribed today Under the existing clearance · no study enrolment needed

Prescribed before discharge. Read at home, by your team.

The heart-failure-specific submission will change what we may say about the device. It does not change what you can deploy. The XK300 Essence is a prescription device for heart rate and breathing rate, and a heart-failure patient is an adult who needs exactly those read, every night, without being asked to do anything.

The path, step by step
  1. Cardiology visit or admissionThe patient is identified before discharge.
  2. XK300 Essence prescribedUnder 510(k) K202464: heart rate and breathing rate in adults, at home.
  3. Home, for months to yearsOn the wall above the bed or under a foam mattress. Nothing worn, nothing charged.
  4. Your team reads the recordResting heart rate, breathing rate, breathing pattern, bed presence and movement, with each night beside the patient's own recent nights. Heartbeat Clarity shown as information.

What is cleared

Measuring heart rate and breathing rate in adults, including in home healthcare. Prescription only.

What is shown as information

Breathing-rate variability as a trend, and Heartbeat Clarity as an investigational measure. Neither is a diagnosis; your clinical judgement stays with you.

How it is covered in the US

Remote patient monitoring: CPT 99453 and 99454 for set-up and the monthly device supply, 99457 and 99458 for management time. For information; your billing team confirms eligibility.

Demo, then deployment

We do not run pilots. A demo on your ward or with your discharge programme, then a deployment scaled to the patients you send home.

Clinical validation Study sites set · not enrolling additional hospitals

Four cardiology programmes. One study. One submission.

Cardiology programmes in Taiwan, the United States and Hong Kong are running the Heartbeat Clarity study: EMR-matched heart-failure outcomes, echocardiogram correlation, and cardiology co-authorship. The sites are set and we are not adding hospitals to the study. What a hospital can do now is deploy.

Now to December 2026

Get ready

Ethics approval, devices installed, EMR feed live at each site.

January to June 2027

Collect

One hundred, then two hundred patients: inpatient, then ninety days at home.

2027

Submit

Database lock, joint paper, and the heart-failure-specific 510(k) submission.

On clearance

The claim changes

The submission unlocks the marketing claim, not the deployment. The device you can prescribe today is the same device.

Heartbeat Clarity is investigational and not a cleared measurement. The XK300 family is cleared to measure heart rate and breathing rate in adults; it does not diagnose heart failure, is not an alarm system for acute life-threatening events, and does not replace clinical monitoring where that is indicated. Early-notice figures are retrospective findings, part of ongoing discovery and research, not claims. XK does not predict or diagnose health events.