NeuraNova Receives FDA 510(k) Clearance for STEDI Device

Milestone establishes the first FDA-cleared product in NeuraNova’s portable neurotechnology portfolio

LOS ANGELES--(BUSINESS WIRE)--NeuraNova, Inc., a medical technology company developing portable, noninvasive technologies for neurological care, today announced that the U.S. Food and Drug Administration 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 Inc., 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.

“FDA clearance of STEDI is a landmark achievement for NeuraNova and a tribute to the extraordinary persistence of our entire team. 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.” — Bob Colloton, Chief Executive Officer, NeuraNova

A New Chapter for Portable Neurotechnology

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.

“This clearance belongs to every person who believed that a fundamentally different approach to brain sensing was possible,” said Shane Shahrestani, M.D., Ph.D., Co-Founder and Chief Scientific & Innovation Officer of NeuraNova. “From the earliest prototypes to the final validation studies, our team confronted difficult scientific, engineering, clinical, and regulatory problems with rigor and resilience. I am so proud of our team, grateful to the patients and volunteers who contributed to STEDI’s development, and energized by what this milestone makes possible.”

A Growing Neurotechnology Portfolio

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.

Built by a Multidisciplinary Team

STEDI’s clearance is the result of sustained collaboration across biomedical engineering, neuroscience, neurosurgery, emergency medicine, regulatory affairs, quality systems, manufacturing, software development, clinical research, and operations. NeuraNova thanks its employees, investigators, clinical partners, study participants, advisors, investors, and early supporters for helping transform an ambitious scientific concept into an FDA-cleared medical device.

“This is a victory for the entire NeuraNova community,” said Alex Ballatori, Co-Founder of NeuraNova. “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.”

About NeuraNova

NeuraNova, Inc. is a medical technology company developing portable, noninvasive sensing and navigation technologies for neurological care. The company’s portfolio includes the FDA-cleared STEDI Device and investigational platforms including FLASH and PinPoint. NeuraNova’s mission is to provide clinicians with timely, objective information and practical guidance closer to the point of care. For more information, visit www.Neura-Nova.com

Important Regulatory Information

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. STEDI’s permitted promotion and use are limited to its FDA-cleared indication, labeling, warnings, precautions, and instructions for use. FLASH and PinPoint are investigational devices in development; they have not been cleared or approved by the FDA and are not available for commercial sale or clinical use. Any descriptions of potential future applications are forward-looking and are not claims of safety or effectiveness. FDA clearance of the STEDI Device under section 510(k) establishes substantial equivalence to a legally marketed predicate device. It does not constitute FDA approval or endorsement of NeuraNova, its technology platform, or any device other than STEDI Device.