NeuraNova, a medical technology company developing portable, noninvasive technologies for neurological care, today announced that the FDA has granted 510(k) clearance to the STEDI Device.
The STEDI Device is a bioimpedance spectroscopy device designed to measure impedance ratios, aiding in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurological assessment. The STEDI Device is an adjunct to standard clinical evaluation methodologies. The clearance represents a defining milestone for NeuraNova, previously known as StrokeDx, and years of focused work by its scientists, engineers, clinicians, study teams, advisors, partners, and supporters.
Designed for use in hospital settings, STEDI is a portable, automated device that noninvasively measures the distribution of fluid within the head and provides clinicians with rapid, objective physiologic information at the bedside. STEDI is intended to be used only in accordance with its FDA-cleared labeling.
STEDI is built on NeuraNova’s proprietary sensor platform, which uses low-energy electromagnetic measurements to characterize physiologic differences within the head. The system was engineered to make repeatable measurements through a streamlined, automated workflow suitable for the bedside. The FDA clearance follows a development and verification program that included engineering validation, repeatability testing, software verification and validation, risk management, and review through the FDA’s 510(k) premarket notification process.
The company's technology includes:
STEDI Device — NeuraNova’s FDA-cleared, portable, automated system, cleared to measure impedance ratios, aiding in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurological assessment as an adjunct to standard clinical evaluation methodologies. STEDI may be marketed and used only for the indication and under the conditions described in its FDA-cleared labeling.
FLASH Device — A compact, handheld platform in development. FLASH has not been cleared or approved by the FDA and is not available for commercial sale or clinical use.
PinPoint Device — A bedside neuronavigation platform in development. PinPoint has not been cleared or approved by the FDA and is not available for commercial sale or clinical use.
Together, STEDI, FLASH, and PinPoint reflect NeuraNova’s long-term development strategy: to create practical neurotechnologies that move critical information and guidance closer to patients while complementing established imaging, procedural workflows, and physician decision-making. Statements regarding FLASH and PinPoint are forward-looking, describe products in development, and are not claims of safety or effectiveness.
