Signos Salient Characteristics.pdf
PDF 110 KB Posted
- Attached to
- DH10--Notice of Intent to Sole Source Signos Continuous Glucose Monitoring - GLP 1 Alternative Pilot
- Solicitation number
- 36C26126Q1035
About this file
This is a Brand Name or Equal Worksheet that establishes salient characteristics for the Signos Continuous Glucose Monitoring System with AI support, manufactured by Signos Health. The document specifies the essential physical, functional, and performance characteristics required for equivalent product submissions. The brand name item consists of a wearable glucose biosensor (Dexcom Stelo Continuous Glucose Biosensor), a mobile application (Signos Mobile Application available for iOS/Android), an artificial intelligence analytics engine, a behavioral and metabolic health recommendation platform, and a cloud-based health data monitoring environment.
Key technical specifications include a small adhesive wearable biosensor worn on the upper arm with approximate dimensions of 27–35 mm diameter and estimated weight under 20 grams. The system must provide continuous glucose monitoring with real-time tracking (24/7 monitoring), automatic Bluetooth data transmission to smartphone applications, and the ability to correlate glucose responses with nutrition, exercise, sleep, and stress factors. The system delivers predictive analytics and behavior recommendations for weight management and metabolic health optimization through a cloud-based analytics platform and mobile app dashboard displaying glucose trends, alerts, and actionable health recommendations. The product is FDA-cleared for over-the-counter use in non-diabetic metabolic health and wellness applications and must support personalized health coaching and lifestyle intervention programs. No compatibility requirements, articulation specifications, or governing body approvals are specified as necessary.
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Other files
| File | Type | Posted |
|---|---|---|
| PWS Signos DRAFT.pdf | ||
| 36C26126Q1035.docx | DOCX document |
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Text version
Brand Name or Equal Worksheet (“Salient Characteristics”)
Brand Name Item: Signos Continuous Glucose Monitoring System with AI support.
1) Essential/significant physical, functional, or performance characteristics.
• Continuous Glucose Monitoring (CGM) wearable biosensor capable of tracking glucose levels in real time
(24/7 monitoring).
• AI-powered mobile application providing personalized metabolic health insights and recommendations.
• Real-time glucose monitoring with automatic Bluetooth data transmission to smartphone application.
• Ability to track and correlate glucose response with nutrition, exercise, sleep, and stress.
• Provides predictive analytics and behavior recommendations for weight management and metabolic health optimization.
• Compatible with FDA-cleared over-the-counter glucose monitoring system for non-diabetic metabolic health and wellness applications.
• Cloud-based analytics platform for longitudinal health trend monitoring.
• Mobile app dashboard displaying glucose trends, alerts, and actionable health recommendations.
• Supports personalized health coaching and lifestyle intervention programs.
2) Compatibility – N/A
3) Dimensions-
• Small wearable adhesive biosensor worn on upper arm.
• Approximate sensor dimensions comparable to standard CGM patch (approximately 27–35 mm diameter depending on sensor generation).
4) Weight
• Estimated weight under 20 grams including adhesive wearable component.
5) Articulation specifications – N/A
6) Purpose The system is designed to provide continuous metabolic monitoring through real-time glucose tracking combined with artificial intelligence-driven analysis to improve:
• Weight management
• Metabolic health optimization
• Personalized nutrition decision making
• Lifestyle behavior modification
• Identification of glucose response patterns related to food intake, exercise, sleep, and stress
• Preventive health monitoring and wellness intervention support
7) Governing Body or Organization – Not Required
8) Complete generic identification
AI-enabled Continuous Glucose Monitoring (CGM) System for metabolic health monitoring and weight management consisting of:
• Wearable glucose biosensor
• Mobile health application
• Artificial intelligence analytics engine
• Behavioral and metabolic health recommendation platform
• Cloud-based health data monitoring environment
Brand Name or Equal Worksheet (“Salient Characteristics”)
9) Applicable model/make/catalog number
• Product Platform: Signos Glucose Monitoring System
• Biosensor Component: Dexcom Stelo Continuous Glucose Biosensor
• Mobile Application: Signos Mobile Application (iOS / Android)
10) Manufacturer name
Signos Health
File details come from the government source that posted it. Updated .