Key Points
- Based on data from its first clinical trial, Arrayus has gained Health Canada approval to treat uterine fibroids.
- The device has a fully phased array and includes intuitive treatment planning tools and real-time therapy monitoring.
Arrayus Technologies, Inc. has announced that its MRI-guided focused ultrasound device obtained Health Canada approval for the ablation of uterine fibroid tissue. The ruling was based on data from the company’s first-in-human clinical trial.
Uterine fibroids are benign tumors that can greatly affect quality of life for women, mainly in their reproductive years. Symptoms include heavy bleeding, problems urinating, and pain. Up to 80% of women will be diagnosed with uterine fibroids in their lifetime.
According to their press release, the Arrayus device is the world’s first clinically available fully phased array that includes intuitive treatment planning tools and real-time therapy monitoring.
“Securing Health Canada approval marks a pivotal moment in the evolution of our technology, but it’s only the beginning,” said James O’Reilly, CEO of Arrayus. “Our platform has the potential to transform patient care across multiple medical specialties. We are committed to pushing the boundaries of medical innovation to reduce the burden on the healthcare system and improve patient outcomes worldwide.”
The Canadian company is also developing focused ultrasound for oncological applications and is seeking its first institutional round of funding to support those endeavors.
Arrayus was founded by renowned focused ultrasound researcher Kullervo Hynynen, PhD, based on work completed during his time at Brigham and Women’s Hospital and Sunnybrook Health Sciences Center. Arrayus was formerly known as Harmonic Medical.