Safety
Over 60 years of clinical use. No recalls. No warnings. No adverse events. The capsule is tethered, retrieved, and never stays in your body.
We’ve been legally marketed in the United States since before 1976. In that time, the FDA MAUDE database contains zero adverse event reports for the Heidelberg pH Capsule. Zero recalls. Zero Warning Letters. That record spans over a million tests across clinical practices, research institutions, and pharmaceutical studies worldwide.
The capsule is tethered with a thin medical-grade thread during the test. This means your practitioner can retrieve it at the end, and it can’t pass beyond your stomach. It does not remain in your body.
The capsule has no battery that could leak. The sensor is solid-state. The radio signal is low-power, like a wireless thermometer. No radiation.
The bicarbonate solution you drink during the test is a standard pharmaceutical-grade preparation. Sodium bicarbonate is commonly used as an antacid and has a well-established safety profile.
This test cannot be performed if you have:
If any of these apply, speak with your doctor about alternatives.
The following do not automatically disqualify you, but your practitioner will need to assess your eligibility before the test can proceed:
Certain medications must be temporarily paused before the test to ensure accurate results:
Do not stop any prescribed medication without speaking to your prescribing physician first. Your practitioner will provide specific guidance based on your situation.
The Heidelberg capsule is tethered throughout the procedure. It’s mechanically retrieved. There’s no adhesive. No component is ever left unattended in your body.
That’s not a new feature. That’s how it’s always been designed.
Regulatory status
The Heidelberg pH Capsule is a Class I, 510(k)-exempt, preamendments device, classified under 21 CFR §876.1400. Registration of an establishment or listing of a device does not denote FDA approval, clearance, or endorsement.
Over 140 peer-reviewed studies and counting.