Is Max Pulse FDA cleared?
Yes. Max Pulse is FDA 510(k) cleared under K110374 as a Class II photoelectric plethysmograph. The clearance covers noninvasive measurement of pulse waveform and heart rate at the left index finger in adults. It does not cover a diagnostic claim for any named cardiac condition, so TITN presents it as a cardiovascular wellness screen and nothing more.
What does the Max Pulse device actually measure?
Max Pulse records one thing: the fingertip pulse waveform, captured by photoelectric plethysmography from the left index finger. Heart rate comes from that same recording and sits inside the cleared measurement. Rhythm regularity is read from the beat-to-beat intervals. The arterial stiffness index is the manufacturer's derived output from the waveform shape, not part of the cleared indication.
Is Max Pulse a diagnostic test or a screening tool?
A screening tool. Max Pulse is not a cardiac diagnostic and does not diagnose coronary artery disease, heart failure, or arrhythmia. It gives the clinician a fast, measured cardiovascular snapshot at the consult. An abnormal or borderline result is a reason to pursue the appropriate indicated workup, not a finding to treat as confirmatory on its own.
What does a Max Pulse screen not replace?
It does not replace ankle-brachial index testing for peripheral arterial disease, echocardiography, or a cardiac stress test. Max Pulse opens the cardiovascular conversation on measured ground; the formal workup still belongs to the indicated diagnostic study. TITN positions the screen as an entry point that helps surface which patients deserve a closer look, ordered when clinically indicated.
How long does the screen take?
About one to three minutes at the chairside. The patient sits, rests, and places the left index finger in the photoelectric sensor. No prep, no gel, no needles. A trained technician or medical assistant runs it rather than the physician, and the structured report is ready at point of care so the clinician can review it with the patient in the room.
Is Max Pulse billed to insurance?
No. TITN offers Max Pulse as a cash-pay wellness screen, and no code is published for it. FDA clearance establishes that a device is safe and substantially equivalent for its stated use; it does not establish payer coverage. CMS's national coverage determination for plethysmography treats the photoelectric method as not providing reproducible blood-flow measurements, which is a separate question from clearance.
Why would a payer call photoelectric plethysmography experimental if it is FDA cleared?
Because clearance and coverage answer different questions. A 510(k) clearance says the device is substantially equivalent to a predicate for its stated measurement. Coverage asks whether that measurement changes clinical outcomes reproducibly enough to pay for. CMS's plethysmography coverage determination and at least one commercial policy have reached a negative answer on the second question while the first stands.
Who is a good candidate for a Max Pulse screening?
Adults interested in a baseline pulse-wave snapshot as part of a wellness, preventive, longevity, or integrative visit. The device is cleared for patients age 18 and older weighing 100 pounds or more. It is not a substitute for indicated diagnostic workup in a patient with cardiac symptoms; those patients need the appropriate cardiac study, not a screen.
Are there limitations or contraindications to a Max Pulse test?
The limitations are those of any fingertip photoelectric sensor: poor perfusion, nail polish or pigment at the sensor site, and motion artifact can all affect the trace. Follow the device documentation rather than assuming a clean capture in every patient. Consistent placement and a rested, steady patient are what make a rescreen a true comparison against the earlier reading.
Why offer the screen at all?
It is a patient-friendly entry point. A one-to-three-minute chairside capture produces an immediate, visual report that gives the preventive conversation something measured to start from, and the same protocol at every visit makes the rescreen a real comparison. It also pairs naturally with the autonomic and vascular testing on TM-Flow when the visit warrants going wider.
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