The US Food and Drug Administration (FDA) has granted breakthrough device designation to Nutromics’ microneedle wearable patch for vancomycin therapeutic drug monitoring.
Approximately 2.9 million patients in the US receive vancomycin therapy every year, with the antibiotic used to treat life-threatening conditions like sepsis.
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The Australia-based company highlighted that the FDA granted the designation for its Vancomycin TDM Patch after determining that it represented a breakthrough technology with the potential to lead to clinical improvement.
According to Nutromics, the FDA specifically considered the device’s workflow improvements, increased accessibility, and expected ability to return actionable results and facilitate modified vancomycin dosing sooner than the current standard of care (SoC).
The current SoC guidelines for intravenous vancomycin monitoring in adults with serious infections emphasises area under the curve (AUC)-guided strategies rather than traditional trough-only targets.
Dr George Chiampas, emergency medicine physician at Northwestern Hospital and a consultant to Nutromics, said: “Vancomycin dosing for individualised patients is incredibly challenging to get right. Access to real-time, continuous data about drug concentrations would meaningfully and positively impact our ability to make dosing decisions.”
Since publishing first-in-human data for its wearable patch in Nature Biotechnology in February 2026, Nutromics has conducted ICU clinical studies in Australia and is preparing for further studies in the US, with a targeted US launch for the patch in 2027 pending a regulatory submission with the FDA.
Commenting on the breakthrough designation, Nutromics’ CEO Peter Vranes said: “Our team is thrilled that the FDA has recognised our patch as a breakthrough technology and has committed to work closely with us on our pivotal study design and submission.”
Vancomycin represents the first of several sensors Nutromics plans to develop with its DNA-based sensing platform. It views multi-analyte sensing to be the next product advancement, with additional sensors planned for development in the future including those for the diagnosis and management of sepsis and cardiovascular disease.
GlobalData analysis reveals that the global patient monitoring market is growing at a CAGR of 1.9% and is forecast to reach a valuation of around $25.7bn in 2035, up from around $21.2bn in 2025.
