BoneMRI for Adolescents receives FDA clearance 

Empowering healthcare providers across the United States with radiation-free bone imaging for those to whom it matters most: children.

Utrecht, March 5, 2024 – BoneMRI for Adolescents has been granted FDA clearance for distribution throughout the United States. This updated BoneMRI version extends its applicability to a broader patient group: adolescents aged 12 and above. With this achievement, healthcare providers across the US can now offer radiation-free bone imaging to younger patients with confidence.

We are delighted that this technology becomes widely available for adolescents in the US, reducing radiation exposure to these vulnerable patients and serving the unmet need of 3D bone visualisation in spine and hip deformities.”

Expressing her enthusiasm, Sarah Bixby, MD, MBA, Section Chief of Musculoskeletal Imaging and Pediatric Radiologist at Boston Children’s Hospital, remarked.

“At Boston Children’s Hospital we want the best care for our patients. We have embraced BoneMRI from the beginning to assess hip pathologies in the adolescent population in a research setting. The clearance of BoneMRI for the adolescent population both in the pelvis/hip and spine will be a huge leap forward for our patients, allowing us to visualise pathologies in the hip and spine in 3D, as we recently demonstrated in several case studies.

BoneMRI for Adolescents facilitates the visualisation of common conditions in the spine like scoliosis and in the pelvic region, such as hip dysplasia, as well as maturation signs such as ossification centres and ring apophyses, without subjecting patients to ionising radiation.

The increased risk of malignancy associated with ionising radiation from CT scans is widely acknowledged¹²³, thereby limiting its appropriateness for diagnostic imaging and treatment planning. This constraint is particularly relevant in adolescents and children due to their increased sensitivity to radiation-induced carcinogenesis and elevated risk of cancer development⁴⁵⁶. The lifetime cancer risk from imaging radiation in planning and navigation of surgery in adolescent idiopathic scoliosis was recently investigated⁷ , highlighting the large contribution of pre-operative CT, for which BoneMRI could offer the radiation free alternative.