NeuraNova has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to the Stedi device—a bioimpedance spectroscopy device designed to measure impedance ratios, aiding in the assessment of fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurological assessment. The Stedi device is intended as an adjunct to standard clinical evaluation methodologies.
This 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, according to a press release from the company.
Designed for use in hospital settings, Stedi is a portable, automated device that non-invasively measures the distribution of fluid within the head and provides clinicians with rapid, objective physiologic information at the bedside.
“US FDA clearance of Stedi is a landmark achievement for NeuraNova and a tribute to the extraordinary persistence of our entire team,” said Bob Colloton, chief executive officer (CEO) of NeuraNova. “We built this company around a simple but ambitious belief: that meaningful information about the brain should be available earlier, closer to the patient, and in more places. Today, that vision takes a major step forward.”
Stedi is built on NeuraNova’s proprietary sensor platform, which uses low-energy electromagnetic measurements to characterise physiologic differences within the head. The system was engineered to make repeatable measurements through a streamlined, automated workflow suitable for the bedside.
The US FDA clearance follows a development and verification programme that included engineering validation, repeatability testing, software verification and validation, risk management, and review, through the regulator’s 510(k) premarket notification process.
“This clearance belongs to every person who believed that a fundamentally different approach to brain sensing was possible,” said Shane Shahrestani, co-founder and chief scientific and innovation officer of NeuraNova. “From the earliest prototypes to the final validation studies, our team confronted difficult scientific, engineering, clinical and regulatory problems with rigour and resilience. I am so proud of our team, grateful to the patients and volunteers who contributed to Stedi’s development, and energised by what this milestone makes possible.”
In addition to the Stedi device, NeuraNova’s growing neurotechnology portfolio includes the Flash device—a compact, handheld platform—and the PinPoint device—a bedside neuronavigation platform. Both of these technologies are currently in development, have not been cleared or approved by the US FDA, and are not available for commercial sale or clinical use.
Together, these three devices are said to 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.
“This is a victory for the entire NeuraNova community,” said company co-founder Alex Ballatori. “The clearance is not the finish line. It is proof that disciplined science, exceptional teamwork and a relentless commitment to patients can open an entirely new chapter in neurotechnology.”
