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The Atmo® Gas Capsule System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal transit times are used for evaluating motility disorders. Gastric Emptying Time (GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Colonic Transit Time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation, to aid in differentiating slow and normal transit constipation. In the case where ileocecal junction transit cannot be determined, the system will report combined Small and Large Bowel Transit Time (SLBTT). Transit times are derived from measures of temperature, hydrogen concentration, and carbon dioxide concentration, and indicators of oxygen level, Capsule tumble, and antenna reflectance. Not for use in pediatric patients.

The Atmo Gas Capsule System is a prescription only ingestible telemetric medical device system used to measure transit times of the gastrointestinal (GI) tract. The system consists of a single-use Capsule, reusable Receiver, Mobile Device with Clinician App, and an online Clinician Portal. Sensors onboard the Capsule provide measurements for temperature, hydrogen concentration, and carbon dioxide concentration, along with indicators of oxygen level, capsule tumble, and antenna reflectance that are used to identify regional gastrointestinal anatomical landmarks. The Capsule data is transmitted from within the GI tract via radiofrequency communication to a Receiver worn by the patient. The Mobile Device runs the Atmo Clinic App, a software application which guides the clinician through the pairing process, Capsule administration, and subsequent transfer of stored data from the Receiver to a cloud server. The Atmo Clinician Portal, accessible through a web browser, displays the resulting data and provides guidance for the physician to review, confirm and create a downloadable Motility Study Report containing whole and regional gut transit times.

The MotiliCap GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined. The system measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices. Not for use in pediatric patients.

The MotiliCap GI Monitoring System is comprised of the following components: - MotiliCap Capsule (Catalog Number: CP-US-7010) - Data Recorder (Catalog Number: MO-US-8001) - Computer Software (MotiliScan: V1. MO-US-8005) - Smartphone App (MotiliCap: V1. MO-US-8006) The single-use capsule consists of the pressure sensor, the pH sensor, and the temperature sensor, which separately measure the pressure, pH, and temperature in the GI tract to determine transit times of the stomach, small bowel, and colon. The system provides information that aids clinicians in the evaluation of motility-related disorders. The data recorder records biomedical data transmitted by the capsule. The MotiliScan software is installed on a general-purpose computer. Before the examination, the software can create a case to start a test. After the test is complete, the software can receive, and process downloaded test data from the data recorder and graphically display the data for easy analysis and review. The MotiliScan software analyzes data and calculates motility indices such as GET, SBTT, CTT, and WGTT. The MotiliCap App is installed on a smartphone. This App is connected to the data recorder via Bluetooth, displays the connection status, and shows information about the capsule connected to the data recorder.

The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined. The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices. Not for use in pediatric patients.

The SmartPill GI Monitoring System senses and records pH and pressure measurements from the entire length of the gastrointestinal tract for use by physicians to aid in the evaluation of gastrointestinal motility diseases and conditions. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGIT™ Software performs data analyses automatically and provides the physician with a printable report containing regional gut transit times: GET - Gastric emptying (transit) time SBTT - Small bowel transit time SLBTT - Combined small and large bowel transit time CTT - Colonic transit time WGTT - whole gut transit time

The SmartPill GI Monitoring System is indicated for use in evaluating patients with suspected delayed gastric emptying (gastroparesis). The SmartPill GI Monitoring System measures pH, pressure and temperature throughout the gastrointestinal tract. These physiological measurements are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). In addition, pressure contraction patterns from the antrum and duodenum are used to calculate motility indices. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Not for use in pediatric populations

The SmartPill GI Monitoring System senses and records pH and pressure measurements from the entire length of the gastrointestinal tract for use by physicians to evaluate patients with delayed gastric emptying. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGI™ Software performs data analyses automatically and provides the physician with a printable report containing gastric emptying time, motility index, and total transit time.