Originally conceived to be the key medical device in the Biosymtec Initiative, a program for governments needing to monitor for bioterrorist attacks and emerging infectious disease pandemics, the Biosymtec Monitor had to be fast, convenient and useable by medical personnel speaking any language.
The Biosymtec Monitor was later developed into a platform to monitor for a variety of pre-symptomatic signs including but not limited to: BMT, PEF, FEV1, FVC, HR and EKG.
Later versions may also monitor for nitric Oxide (NO), blood oxygen saturation percentage (SpO2), Respiration Rate (RR) and even blood glucose levels (BS).
There is no comparison.
No competitor currently has the equivalent of the Biosymtec Monitor or the Biosymtec System. One competitor is planning on offering a device to acquire certain data from a patient's mouth, but they have no means of detecting infections early (i.e., in the incubation stage) as does the Biosymtec Monitor.
Regulatory Agencies (FDA, EU MDR, TPD, NMPA)
The Biosymtec Monitor is designed to be used exclusively in the home, upon waking, by the purchaser (never in the hospital or doctor's office). The onboard software provides the purchaser with a graphic report indicating the likelihood of developing:
but the device itself does not diagnose. We are told, the FDA will not regulate such a device. The Biosymtec System graph is not expected to require 510K clearance. On the other hand, the EKG feature may require 510K Clearance, however, many Predicate Devices are already on the market.