News | FDA | August 18, 2023

Kitware leveraged the cutting-edge 3D Slicer medical visualization platform to develop custom medical imaging software and provided support throughout the FDA application process 

Kitware leveraged the cutting-edge 3D Slicer medical visualization platform to develop custom medical imaging software and provided support throughout the FDA application process

August 18, 2023 — Kitware, a leader in developing innovative medical visualization software, is pleased to announce its successful collaboration with Polarean, Inc. – a medical imaging technology company and long-standing customer – and their recent FDA-approval of their lung imaging technology. 

Polarean’s XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129Xe MR image and a proton chest MR image to provide visualization and evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. This image analysis platform quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129Xe ventilation MR image and accompanying proton chest MR image. The software, developed by Kitware based on Polarean’s technology will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images. XENOVIEW VDP was built using 3D Slicer, an open-source medical imaging software that Kitware helps develop, and provides advanced 3D image analysis and structured clinical reporting tailored to the lung images acquired by XENOVIEW MRI technology.  

The Kitware team also supported Polarean’s FDA 510(k) application through technical guidance and documentation. Dr. Kiarash Emami, VP of Technology & Applications at Polarean remarked, "We have really enjoyed working with the Kitware team along the way and found them to be an excellent partner throughout this project." 

"Polarean's milestone is truly commendable, and we at Kitware extend our warmest congratulations," expressed Dr. Andinet Enquobahrie, Senior Director of Medical Computing at Kitware. “We believe in the power of innovation and collaboration and look forward to nurturing our collaboration to reach even greater heights in the future." 

Kitware has nearly 25 years of experience developing and deploying cutting-edge solutions for medical technology companies ranging from small companies like Polarean to Fortune 500 companies. Learn how Kitware can help bring impactful and innovative medical device technology to market.  

For more information: www.kitware.com 


Related Content

News | Magnetic Resonance Imaging (MRI)

July 2, 2025 — Philips has received FDA 510(k) clearance for SmartSpeed Precise[1] MR’s latest deep learning ...

Time July 03, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

June 26, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for the Magnetom Flow.Ace, its ...

Time June 26, 2025
arrow
News | Prostate Cancer

June 26, 2025 – Quibim, a global provider of quantitative medical imaging solutions, has launched AI-QUAL, a new feature ...

Time June 26, 2025
arrow
News | PET Imaging

Jun. 24, 2025 — GE HealthCare has announced that the U.S. Food and Drug Administration (FDA) approved an updated label ...

Time June 24, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

June 24, 2025 —Smart Soft Healthcare has announced that CoLumbo, the company's advanced AI spine assistant, has received ...

Time June 24, 2025
arrow
News | Contrast Media

June 17, 2025 — Bayer has announced the submission of a New Drug Application (NDA) to the US Food and Drug ...

Time June 20, 2025
arrow
News | Point-of-Care Ultrasound (POCUS)

June 17, 2025 — Royal Philips has announced the global launch of the Flash Ultrasound System 5100 POC — a new point-of ...

Time June 19, 2025
arrow
News | Lung Imaging

June 18, 2025 — Exo recently announced that now included on its Exo Iris is the first ever FDA 510(k) cleared AI for ...

Time June 18, 2025
arrow
News | Breast Imaging

June 2, 2025 — Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S ...

Time June 02, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

May 29, 2025 — Hyperfine, Inc., producer of the world’s first FDA-cleared AI-powered portable MRI system for the brain — ...

Time May 29, 2025
arrow
Subscribe Now