Skip to Content Facebook Feature Image

Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone

Business

Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone
Business

Business

Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone

2026-02-06 22:00 Last Updated At:22:15

  • Following AQUA and SCALE PET, the latest FDA clearance reinforces Neurophet's leadership in AI-based Alzheimer's disease imaging analysis
  • Advanced analysis of neuroimaging features associated with cerebral microbleeds and edema supports imaging-based clinical decision-making and accelerates U.S. market expansion

SEOUL, South Korea, Feb. 6, 2026 /PRNewswire/ -- Neurophet (Co-CEOs Jake Junkil Been and Donghyeon Kim), an artificial intelligence (AI) solution company for brain disorders diagnosis and treatment, announced today that its software solution, Neurophet AQUA AD Plus, a comprehensive neuroimaging analysis solution for clinical evaluation related to Alzheimer's disease, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

This clearance marks Neurophet's third FDA 510(k) clearance, following Neurophet AQUA, a brain neurodegeneration imaging analysis software, and Neurophet SCALE PET, a PET image quantitative analysis software. The achievement further validates the safety and effectiveness of Neurophet's core product portfolio at a global regulatory standard.

Neurophet AQUA AD Plus is a software-based solution designed to support imaging-based clinical evaluation across the Alzheimer's disease care continuum. The software performs quantitative analysis of MRI and PET images, enabling automated labeling, visualization, volumetric quantification of brain structures and lesions, as well as standardized uptake value ratio (SUVR) analysis. Quantitative results can be compared with normative reference data to support the evaluation of neurodegeneration and cognitive impairment.

The FDA-cleared U.S. version of Neurophet AQUA AD Plus is an upgraded solution that builds upon the capabilities of Neurophet AQUA AD. Leveraging AI-based brain MRI analysis, the software automatically analyzes and quantifies:

- Hypointense lesions associated with cerebral microbleeds and superficial siderosis, and

- Hyperintense lesions related to brain edema

By providing automated lesion localization and counts, the software helps clinicians more precise assess imaging-based risk factors and supports informed, patient-specific clinical decision-making when evaluating patients undergoing Alzheimer's disease-related therapeutic management.

"Receiving FDA 510(k) clearance for Neurophet AQUA AD Plus represents a significant milestone that allows us to introduce our advanced Alzheimer's imaging technology more broadly in the U.S. market," said Jake Junkil Been, Co-CEO of Neurophet. "We plan to accelerate our expansion across the U.S. by strengthening collaborations with healthcare institutions and strategic partners."

Neurophet AQUA AD Plus was previously designated as an Innovative Medical Technology in South Korea in September 2025. Building on this momentum, Neurophet plans to progressively expand clinical adoption of the solution across global healthcare settings, further broadening its global footprint in AI-based neuroimaging.

About Neurophet

Neurophet specializes in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain disorders based on cutting-edge artificial intelligence (AI) technology. The company was founded in 2016 by Co-CEOs Jake Junkil Been and Donghyeon Kim, who developed the next-generation neuro-navigation system.

Major products include brain MRI analysis software "Neurophet AQUA", PET Image Quantitative Analysis Software "Neurophet SCALE PET", Brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet tES/TMS LAB", Alzheimer's Disease treatment prescription and monitoring software "Neurophet AQUA AD" for tracking treatment efficacy and side effects, and Multiple Sclerosis image analysis software "Neurophet AQUA MS".

Neurophet has set its top priority to helping patients suffering from brain disorders. Based on expertise in neuroscience, Neurophet will continue to challenge and grow to explore the human brain's health and pioneer solutions for brain diseases with AI technology.

  • Following AQUA and SCALE PET, the latest FDA clearance reinforces Neurophet's leadership in AI-based Alzheimer's disease imaging analysis
  • Advanced analysis of neuroimaging features associated with cerebral microbleeds and edema supports imaging-based clinical decision-making and accelerates U.S. market expansion

SEOUL, South Korea, Feb. 6, 2026 /PRNewswire/ -- Neurophet (Co-CEOs Jake Junkil Been and Donghyeon Kim), an artificial intelligence (AI) solution company for brain disorders diagnosis and treatment, announced today that its software solution, Neurophet AQUA AD Plus, a comprehensive neuroimaging analysis solution for clinical evaluation related to Alzheimer's disease, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

This clearance marks Neurophet's third FDA 510(k) clearance, following Neurophet AQUA, a brain neurodegeneration imaging analysis software, and Neurophet SCALE PET, a PET image quantitative analysis software. The achievement further validates the safety and effectiveness of Neurophet's core product portfolio at a global regulatory standard.

Neurophet AQUA AD Plus is a software-based solution designed to support imaging-based clinical evaluation across the Alzheimer's disease care continuum. The software performs quantitative analysis of MRI and PET images, enabling automated labeling, visualization, volumetric quantification of brain structures and lesions, as well as standardized uptake value ratio (SUVR) analysis. Quantitative results can be compared with normative reference data to support the evaluation of neurodegeneration and cognitive impairment.

The FDA-cleared U.S. version of Neurophet AQUA AD Plus is an upgraded solution that builds upon the capabilities of Neurophet AQUA AD. Leveraging AI-based brain MRI analysis, the software automatically analyzes and quantifies:

- Hypointense lesions associated with cerebral microbleeds and superficial siderosis, and

- Hyperintense lesions related to brain edema

By providing automated lesion localization and counts, the software helps clinicians more precise assess imaging-based risk factors and supports informed, patient-specific clinical decision-making when evaluating patients undergoing Alzheimer's disease-related therapeutic management.

"Receiving FDA 510(k) clearance for Neurophet AQUA AD Plus represents a significant milestone that allows us to introduce our advanced Alzheimer's imaging technology more broadly in the U.S. market," said Jake Junkil Been, Co-CEO of Neurophet. "We plan to accelerate our expansion across the U.S. by strengthening collaborations with healthcare institutions and strategic partners."

Neurophet AQUA AD Plus was previously designated as an Innovative Medical Technology in South Korea in September 2025. Building on this momentum, Neurophet plans to progressively expand clinical adoption of the solution across global healthcare settings, further broadening its global footprint in AI-based neuroimaging.

About Neurophet

Neurophet specializes in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain disorders based on cutting-edge artificial intelligence (AI) technology. The company was founded in 2016 by Co-CEOs Jake Junkil Been and Donghyeon Kim, who developed the next-generation neuro-navigation system.

Major products include brain MRI analysis software "Neurophet AQUA", PET Image Quantitative Analysis Software "Neurophet SCALE PET", Brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet tES/TMS LAB", Alzheimer's Disease treatment prescription and monitoring software "Neurophet AQUA AD" for tracking treatment efficacy and side effects, and Multiple Sclerosis image analysis software "Neurophet AQUA MS".

Neurophet has set its top priority to helping patients suffering from brain disorders. Based on expertise in neuroscience, Neurophet will continue to challenge and grow to explore the human brain's health and pioneer solutions for brain diseases with AI technology.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone

Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone

Announced alongside M Series Smart Assist Module launch on Kickstarter

NEW YORK, April 4, 2026 /PRNewswire/ -- Yarbo, a company focused on intelligent yard robotics, today announced the Yarbo Open Platform, a long-term initiative currently under development and planned for release in early 2027. Designed to expand Yarbo's modular yard robot system across both software and hardware, the platform is intended to support deeper customization, broader smart home connectivity, and new forms of user and developer-driven functionality over time. The announcement coincides with the launch of the Smart Assist Module (SAM) for the M Series on Kickstarter.

The Open Platform is not available today. Instead, it reflects Yarbo's roadmap for how its ecosystem may evolve over time, including a three-layer software architecture built around an Open API, SDK, and no-code Automation Editor, as well as a hardware expansion framework designed to support future user-built and developer-built modules.

A Structured Approach to Software Integration and Automation

The Yarbo Open Platform is structured to accommodate different levels of technical expertise, from everyday users to experienced developers. It is designed to provide multiple entry points into the Yarbo ecosystem, enabling both software-driven automation and hardware-level expansion.

On the software side, the platform consists of three layers:

  • Yarbo Open API — intended to enable connectivity between Yarbo devices and external platforms, allowing them to participate in broader home automation scenarios.
  • Yarbo SDK — a set of development tools, including code libraries and documentation, designed for developers building custom features or integrations.
  • Yarbo Automation Editor — a visual, drag-and-drop interface within the Yarbo app that allows users to create automation workflows without writing code.

Together, these components are intended to make automation accessible to a wide range of users, while also supporting more advanced development use cases.

The platform is also designed to support compatibility with widely used smart home ecosystems, including Home Assistant, Google Home, and Amazon Alexa, enabling users to incorporate Yarbo into existing connected home setups.

Extending Capability Through Hardware

In addition to software capabilities, the Open Platform introduces a hardware expansion approach designed to extend Yarbo's functionality beyond its existing modules.

At the center of this is CoreBridge, a standardized hardware interface currently in development that is intended to provide access to Yarbo's mechanical mounting points, power system, and data connections. It is designed to support third-party development and user-built extensions, allowing new types of functionality beyond pre-defined modules.

One example of this extensibility is an electromagnet-based module, which can be attached via CoreBridge to enable Yarbo to latch onto and move objects such as garbage bins. In a potential use scenario, this could enable automated movement of a bin to the curb on collection day and its return afterward.

This combination of software and hardware openness reflects an effort to expand the role of outdoor robotics beyond fixed-function devices.

Smart Assist Module Launch on Kickstarter

Alongside the Open Platform announcement, Yarbo is launching the Smart Assist Module (SAM) for the M Series on Kickstarter.

The module introduces two primary features designed to expand how users interact with their yard robot in everyday use:

  • Follow Me Mode — enabling Yarbo to move alongside the user while carrying tools or materials, reducing the need for manual transport during yard work.
  • Patrol Mode — allowing Yarbo to move along customizable routes around the property, with features such as remote live view, app-based alerts, and optional audio notifications via its built-in speaker, providing an added layer of awareness and convenience for users managing outdoor spaces.

The Smart Assist Module is positioned as part of Yarbo's broader effort to extend the practical use cases of its modular system.

Looking Ahead

The Yarbo Open Platform is planned for release in early 2027 and is being developed to support both the Y Series and M Series. By introducing a framework that combines software integration, developer tools, and hardware extensibility, Yarbo aims to enable a broader range of applications while allowing users to define how the system evolves over time.

Further details will be shared as development progresses.

About Yarbo

Yarbo is defining a new category of outdoor robotics with its Modular Yard Robot. Known for its automated snow blower robots, Yarbo introduced a modular system designed for year-round use. Powered by a single intelligent core unit, the system supports interchangeable modules for mowing, leaf blowing, snow clearing, and more—creating a more efficient approach to outdoor maintenance for homeowners.

Announced alongside M Series Smart Assist Module launch on Kickstarter

NEW YORK, April 4, 2026 /PRNewswire/ -- Yarbo, a company focused on intelligent yard robotics, today announced the Yarbo Open Platform, a long-term initiative currently under development and planned for release in early 2027. Designed to expand Yarbo's modular yard robot system across both software and hardware, the platform is intended to support deeper customization, broader smart home connectivity, and new forms of user and developer-driven functionality over time. The announcement coincides with the launch of the Smart Assist Module (SAM) for the M Series on Kickstarter.

The Open Platform is not available today. Instead, it reflects Yarbo's roadmap for how its ecosystem may evolve over time, including a three-layer software architecture built around an Open API, SDK, and no-code Automation Editor, as well as a hardware expansion framework designed to support future user-built and developer-built modules.

A Structured Approach to Software Integration and Automation

The Yarbo Open Platform is structured to accommodate different levels of technical expertise, from everyday users to experienced developers. It is designed to provide multiple entry points into the Yarbo ecosystem, enabling both software-driven automation and hardware-level expansion.

On the software side, the platform consists of three layers:

  • Yarbo Open API — intended to enable connectivity between Yarbo devices and external platforms, allowing them to participate in broader home automation scenarios.
  • Yarbo SDK — a set of development tools, including code libraries and documentation, designed for developers building custom features or integrations.
  • Yarbo Automation Editor — a visual, drag-and-drop interface within the Yarbo app that allows users to create automation workflows without writing code.

Together, these components are intended to make automation accessible to a wide range of users, while also supporting more advanced development use cases.

The platform is also designed to support compatibility with widely used smart home ecosystems, including Home Assistant, Google Home, and Amazon Alexa, enabling users to incorporate Yarbo into existing connected home setups.

Extending Capability Through Hardware

In addition to software capabilities, the Open Platform introduces a hardware expansion approach designed to extend Yarbo's functionality beyond its existing modules.

At the center of this is CoreBridge, a standardized hardware interface currently in development that is intended to provide access to Yarbo's mechanical mounting points, power system, and data connections. It is designed to support third-party development and user-built extensions, allowing new types of functionality beyond pre-defined modules.

One example of this extensibility is an electromagnet-based module, which can be attached via CoreBridge to enable Yarbo to latch onto and move objects such as garbage bins. In a potential use scenario, this could enable automated movement of a bin to the curb on collection day and its return afterward.

This combination of software and hardware openness reflects an effort to expand the role of outdoor robotics beyond fixed-function devices.

Smart Assist Module Launch on Kickstarter

Alongside the Open Platform announcement, Yarbo is launching the Smart Assist Module (SAM) for the M Series on Kickstarter.

The module introduces two primary features designed to expand how users interact with their yard robot in everyday use:

  • Follow Me Mode — enabling Yarbo to move alongside the user while carrying tools or materials, reducing the need for manual transport during yard work.
  • Patrol Mode — allowing Yarbo to move along customizable routes around the property, with features such as remote live view, app-based alerts, and optional audio notifications via its built-in speaker, providing an added layer of awareness and convenience for users managing outdoor spaces.

The Smart Assist Module is positioned as part of Yarbo's broader effort to extend the practical use cases of its modular system.

Looking Ahead

The Yarbo Open Platform is planned for release in early 2027 and is being developed to support both the Y Series and M Series. By introducing a framework that combines software integration, developer tools, and hardware extensibility, Yarbo aims to enable a broader range of applications while allowing users to define how the system evolves over time.

Further details will be shared as development progresses.

About Yarbo

Yarbo is defining a new category of outdoor robotics with its Modular Yard Robot. Known for its automated snow blower robots, Yarbo introduced a modular system designed for year-round use. Powered by a single intelligent core unit, the system supports interchangeable modules for mowing, leaf blowing, snow clearing, and more—creating a more efficient approach to outdoor maintenance for homeowners.

** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

Yarbo Introduces Open Platform Strategy, Opening Its Robotics System to Developers and Smart Home Ecosystems

Yarbo Introduces Open Platform Strategy, Opening Its Robotics System to Developers and Smart Home Ecosystems

Yarbo Introduces Open Platform Strategy, Opening Its Robotics System to Developers and Smart Home Ecosystems

Yarbo Introduces Open Platform Strategy, Opening Its Robotics System to Developers and Smart Home Ecosystems

Recommended Articles