VISIONAIR

by PacificMD Biotech  · Based in United States →Reimagining the Way Medical Devices Are Designed
Otolaryngology (ENT) Pulmonology Radiology

Contact-vendor
Regulatory Status Disclosed

Overview

VISIONAIR by PacificMD Biotech is an artificial intelligence tool designed to assist in the analysis of medical imaging. It is primarily intended for use by radiologists and other specialists involved in diagnostic imaging within hospital and outpatient care settings. The tool integrates into existing clinical workflows by providing automated or semi-automated analysis of medical images, potentially aiding in the identification of abnormalities or patterns that may be relevant for diagnosis. VISIONAIR’s notable capabilities include its focus on specific imaging modalities and its aim to support diagnostic efficiency. The system is designed to complement the expertise of healthcare professionals by offering an additional layer of analytical support during image review.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered medical imaging analysis
  • Real-time diagnostics
  • Automated reporting (PDF, CSV, and other formats)
  • Clinical decision support
  • Encrypted and anonymous patient data management
  • Workflow optimization
  • Integration with EHR systems (e.g., Epic, Cerner)
  • Data visualization tools
  • Predictive analytics
  • User-friendly interface

Use Cases

  • Determining airflow obstruction in real-time
  • Improving diagnostics for challenging anatomical regions
  • Measuring nasal respiratory airway from endoscopic images
  • Assessing nasal patency and detecting obstructions or congestion
  • Supporting surgical decision-making

What Physicians Need to Know

FDA Clearance Pathway
510(k) cleared. The VISIONAIRu2122 device was determined to be substantially equivalent to a predicate device for its intended use.
Supported Modalities
Endoscopic images for nasal respiratory airway analysis (Internal Nasal Valve and Nasal Cavum). It is designed for use with third-party endoscopic systems.
AI Model Architecture (deep learning approach)
Utilizes a trained AI algorithm for automatic analysis and segmentation of endoscopic images to measure nasal valve and nasal cavum surface areas.
PACS Integration Method
Interfaces with third-party endoscopic systems via smart device ports for video streaming. Data is managed through a database file system and can interface securely and anonymously with a cloud server via the REAl module.
Reading Room Workflow Impact
Can be used pre-, during, or post-procedure to measure nasal respiratory airway. It stores data locally or to the cloud and generates reports with quantitative and qualitative information.
DICOM Support & Standards
Not explicitly mentioned in the provided information. Data storage involves encrypted patient endoscopic anatomical images and videos.
Processing Speed (per study)
Specific processing speed per study is not explicitly detailed in the provided information. The AI algorithm automatically analyzes images for segmentation and measurement.
RSNA/ACR Validation
No specific mention of RSNA or ACR validation for VISIONAIRu2122 from PacificMD Biotech in the provided information.
Physician Tip

VISIONAIRu2122 is specifically designed for nasal respiratory airway analysis using endoscopic images, offering automated AI-driven measurements of the internal nasal valve and nasal cavum. Physicians should note its utility in pre-, during, and post-procedural assessment and data management. While it provides objective metrics, its application is distinct from traditional radiological modalities like CT or MRI. Consider its secure local and cloud data storage for patient information and reports. The system's integration is primarily with third-party endoscopic systems, not conventional PACS.

Integration is achieved through smart device ports for connecting with third-party endoscopic systems, allowing video streaming to the VISIONAIRu2122 application. Data management includes a secure, anonymous interface with a cloud server via the REAl module, and local storage options. The system creates encrypted patient directories for endoscopic images and videos, ensuring data security and privacy.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact-vendor Contact PacificMD Biotech for pricing information.
DeploymentOn-premise, cloud-integrated
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The VISIONAIR™ system is an FDA-cleared software application (K221892, cleared October 5, 2022) intended for prescription use with third-party endoscopic systems. It measures the nasal respiratory airway from endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).

Integrations
EHR Not specified
Specialties Otolaryngology (ENT), Pulmonology, Radiology

Ratings & Reviews

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Press & Coverage

FDA
510(k) Premarket Notification - VISIONAIR
The FDA granted 510(k) premarket notification for VISIONAIR, a software application by PacificMD Biotech, LLC, intended for use with third-party endoscopic systems to measure the nasal respiratory airway. The system measures the nasal respiratory airway from endoscopic images taken in the region of the internal nasal valve and nasal cavum.
2022-10
PMC (PubMed Central)
New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022
This peer-reviewed article highlights VISIONAIRu2122 Rhinoanemometer by PacificMD Biotech as a new medical device approval in otolaryngology for 2022. It describes VISIONAIR as a software application that offers a faster, noninvasive alternative to traditional rhinometry methods by using light reflection technology and an AI algorithm to measure the nasal airway from endoscopic images.
2024-01
FDA
TPLC - Total Product Life Cycle - VISIONAIR (K221892)
The FDA's Total Product Life Cycle (TPLC) database entry confirms the substantial equivalence decision for VISIONAIR (K221892) manufactured by PacificMD Biotech, LLC. The device is classified as a rhinoanemometer for the measurement of nasal decongestion.
2026-05
ResearchGate (BMC Anesthesiology)
Artificial intelligence in anaesthesiology: why don't we have it in our hands after a decade of innovation? A systematic review and perspective
This systematic review on AI in anesthesiology mentions VISIONAIR by PacificMD Biotech LLC as an FDA-approved medical machine learning application for the measurement of the nasal respiratory airway. The article discusses the challenges in translating AI innovations into clinical practice despite extensive research.
2026-06
Scribd (Texas Department of Information Resources)
TX-RAMP Certified Cloud Services List
VISIONAIR by Biotech Visiontree DataKeeper is listed on the Texas Risk and Authorization Management Program (TX-RAMP) Certified Cloud Services List, indicating its compliance with Texas state security standards for cloud services.
2025-01
HealthAidb
Alternative products to Cadence Health Analytics - HealthAidb
HealthAidb lists VISIONAIR u2014 PacificMD Biotech as an alternative product to Cadence Health Analytics, categorizing it under diagnostic support for clinical care in otolaryngology software development.
unknown

Videos

Product demos, reviews, and walkthroughs for VISIONAIR.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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