InsightRX Nova

What does the vendor say about FDA, CE and security?

The vendor's security and regulatory page says Nova "is not considered to be a medical device in the U.S." and "has not been submitted to the U.S. Food and Drug Administration for review or clearance". For Europe it says Nova is self-certified as a Class I medical device under the EU Medical Device Directive and carries the CE mark.

The same page claims HITRUST CSF certification at the risk-based two-year (r2) level, conformance to ISO 13485, GDPR compliance and compliance with 21 CFR Part 11. It lists no SOC 2 report and says nothing on HIPAA or a BAA.

How does Nova set a dose?

The vendor says Nova uses validated pharmacokinetic models and real-time patient data, with AUC-guided vancomycin dosing under the 2020 consensus guideline and "dozens of drugs" in "90+ Drug Modules". It calls Nova a Bayesian MIPD app and mentions agentic AI at platform level. What it calls Continuous Learning, described as patented, retrains the models on outcomes from the company's network with "no action from clinical or IT teams". The vendor lists Apollo analytics and 24/7 support, and quotes a pharmacy manager on reduced kidney injury with some antibiotics. A separate Nova for Life Sciences version serves clinical trials.

Vendor-reported figures include 1,000+ hospitals and health systems, 2.4M+ patients impacted and 6.2M+ doses personalized. One health system reported a 50% reduction in severe AKI and a $3.6M annualized cost reduction, and the site ties neither to a paper. A KLAS Emerging Company Spotlight score of 96.1 appears against a 2025 Best in KLAS average of 80.6.

What do the papers show?

Papers from 2019 to 2026 name InsightRX or InsightRx Nova. Three carry the vendor's San Francisco affiliation: an iohexol clearance model in renal transplant (Clin Pharmacokinet, 2021), a tacrolimus simulation trial (Ther Drug Monit, 2022) and a very large multi-site retrospective study of how age and BMI affect vancomycin model choice (Pharmacotherapy, 2024).

Among hospital-run studies, a 2026 Pharmacotherapy paper (PMID 42444076) compared Bayesian estimates from InsightRx with first-order vancomycin AUC24 in 196 pediatric patients. Agreement was 84.2% with two concentrations and 54.5% in neonates with one concentration. A 2025 Pharmacotherapy paper assessed the predictive performance of two cefepime models in InsightRX, and a 2025 Medicines paper looked at Bayesian vancomycin AUC estimates at BMI above 40. A 2020 Frontiers in Pharmacology paper describes an institution adopting the cloud tool for busulfan dosing in pediatric transplant.

Founders, funding and price

InsightRX, Inc. gives a Market Street address in San Francisco. Three pharmacometricians founded it in February 2015, and Sirj Goswami, PhD, is co-founder and CEO. The vendor site lists a $10M Series A from October 2019 without naming the investors. InsightRX links no pricing page from its homepage.

The verdict

Hospital pharmacy teams on Epic that want a vendor-supplied Bayesian dosing app are the fit, and an institution whose procurement policy requires FDA clearance is not.