Medical Disclaimer
Effective Date: January 1, 2026 · Last Updated: September 22, 2026
Important Notice
Vancomyzer™ is a clinical decision support tool for use by licensed healthcare professionals only. It is not intended for use by patients, caregivers, or individuals without appropriate clinical training in pharmacokinetics and therapeutic drug monitoring.
Vancomyzer™ is not intended to replace clinical judgment. All dosing recommendations generated by this software must be independently verified by a qualified clinician before being applied to patient care. The software provides decision support only and does not constitute medical advice, diagnosis, or treatment.
Vancomyzer™ is not FDA-cleared as a medical device. This statement does not establish an exemption from medical-device requirements.
All dosing recommendations must be independently verified by a qualified clinician. Dōsys Health LLC and its officers, employees, and agents shall not be liable for any clinical decisions made based on information provided by Vancomyzer™.
Regulatory considerations
Regulatory status depends on each software function, intended use, and jurisdiction. Transparent calculations, manual data entry and clinician review do not by themselves establish non-device status. This page does not establish FDA clearance or an exemption. Institutions should obtain product-specific regulatory documentation before adoption.
FDA Clinical Decision Support Software guidance · January 2026Parenteral Nutrition: evaluation release
Dōsys Parenteral Nutrition is an evaluation release for synthetic adult cases only. It has not completed independent clinical validation and is not for patient care. Clinical equations, safety rules and population-specific recommendations require independent review before any clinical release. Scope is adults; pediatric and neonatal PN are excluded.
Clinical Model & Limitations
Vancomyzer™ uses the Colin PJ et al. (2019) two-compartment population pharmacokinetic model for vancomycin, a published, peer-reviewed model. Vancomyzer™ itself has not been validated in real patients, and no claim is made that its use improves patient outcomes.
The model has known limitations:
- Not validated for patients on renal replacement therapy (RRT), including hemodialysis, CRRT, or peritoneal dialysis. Vancomyzer™ withholds recommendations for these patients.
- Not validated for pediatric patients under 18 years of age (the Colin 2019 model includes pediatric data, but Vancomyzer is configured for adult patients only).
- Accuracy depends on the quality and timing of input data. Serum creatinine values should reflect current renal function. Drug levels should be drawn at appropriate times relative to dosing.
- Population PK models provide estimates based on population-level data. Individual patient pharmacokinetics may differ from model predictions.
Limitation of Liability
Dōsys Health LLC provides Vancomyzer™ “as is” and makes no warranties, express or implied, regarding the accuracy, completeness, reliability, or suitability of the software for any particular purpose.
In no event shall Dōsys Health LLC, its founders, officers, employees, agents, or advisors be liable for any direct, indirect, incidental, special, consequential, or punitive damages arising from the use of or inability to use Vancomyzer™, including but not limited to damages for loss of profits, data, or patient outcomes.
By using Vancomyzer™, the healthcare professional acknowledges that they have read, understood, and agree to this disclaimer, and that they accept full clinical responsibility for all dosing decisions made in the care of their patients.
References
- Colin PJ, et al. Clin Pharmacokinet. 2019;58(6):767–780. doi:10.1007/s40262-018-0727-5
- Rybak MJ, et al. Am J Health-Syst Pharm. 2020;77(11):835–864. doi:10.1093/ajhp/zxaa036
- 21st Century Cures Act, Section 3060. Public Law 114-255 (2016).
Questions about this disclaimer? Contact us at legal@dosys.health or visit our Science & Methodology page for detailed technical documentation.