Planmed to distribute Disior medical imaging software in the USA after Bonelogic receives 510(k) clearance from the US Food and Drug Administration

On February 5th, Disior’s class II medical imaging software device for treatment and surgical planning in the field of orthopedics (foot & ankle and hand & wrist) Bonelogic (Bonelogic 2.0) received 510(k) clearance from the US FDA.

Within the Planmed-Disior distribution agreement Bonelogic is paired with Planmed’s Verity. The Verity is a low-dose extremity CT scanner which provides 3D images of extremities like the hand & wrist and the foot & ankle. It was the first device in the market able to provide 3D images of the foot & ankle region under natural loading conditions, an imaging technique now commonly termed weight-bearing CT (WBCT).

WBCT scanners like the Verity alongside automated medical imaging software like Bonelogic are considered are to be at the forefront of medical innovations for extremity orthopedics. Within the foot & ankle complex, WBCT is a proven tool in both European and American orthopedic clinics for the following common conditions:

• Hallux Valgus
• Syndesmotic injuries and instabilities
• Progression collapse foot deformity
• Extremity arthritis

Bonelogic allows for complete orthopedic characterization of the foot & ankle, as well as the hand & wrist. The software provides mathematical models of a patients’ anatomy and metrics that describe the relationship between bones, which are essential to understanding the degree of pathology or trauma.

“The technology within Bonelogic means that this type of analysis is completed in minutes. Whereas, in most other medical imaging software it would take hours. Therefore, with Bonelogic the barriers to clinical adoption of 3D analytics are removed.” Anna-Maria Henell, CEO, Disior.

The magic of combining the distribution of the Verity extremity CT and Bonleogic is that clinical workflows for common hand & wrist and foot & ankle conditions can be optimized. Reducing the workload of radiologists and clinicians.

“Bringing Bonelogic to the USA market has been a long-term goal for Disior and receiving the 510(k) FDA clearance is a huge achievement. By entering the US market with Planmed we can combine our resources to bring a new standard of care to US orthopedics.” Anna-Maria Henell, CEO, Disior.

Contact Disior to find out more

“We are excited to be able to offer the Disior automatic segmentation and analysis software to our customers in the USA. These features are something our customers have requested, and we are happy to answer their needs,” says Johan Moed, National Sales Manager of Planmed USA. “Our Extremity CT solution is now more versatile than ever before. It is an easy-to-use and cost-effective solution, which makes it a great tool for any imaging center, clinic or hospital.”

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For more information, please contact:
Johan Moed
National Sales Manager, Planmed USA
johan.moed@planmed.com
+1-630-235-4389

Anna-Maria Henell
CEO, Disior
anna-maria@disior.com
+358 50 48 36433

 Disior Oy and Planmed
 
Disior Oy's mission is to provide medical professionals with the diagnostic information they need to deliver perfectly-tailored treatments to every patient. To do this Disior develops novel ways to automate the analysis of bones and soft tissue, linking medical doctors with engineers and mathematicians. The company owners include both leading orthopedic and maxillofacial surgeons as well as technology visionaries.

Planmed Oy dedicates its effort to the development, manufacturing and marketing of advanced imaging equipment and accessories that provide a unique combination of image quality and ease of use for medical imaging professionals. The company offers products for mammography and orthopedic imaging that are well-known for imaging performance, user-friendliness and good ergonomics. Since 1989, Planmed systems have provided tools for healthcare professionals in over 70 countries worldwide. Planmed Oy is part of the Finnish Planmeca Group, which operates in the field of health care technology.