UPDATE: Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI

Updated to include comment from Aspect Imaging

The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging.

The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on nenonates with a head circumference of up to 38 cm and a weight between 1 and 4.5 kg, according to an FDA release. The system includes a temperature-controlled incubator which can be placed directly into the MRI system to reduce movement.

“The vision of Aspect Imaging is to bring clinical diagnostic information to where it is needed the most, and to help neonatologists with their diagnostic decisions. It is now possible to routinely scan premature babies in the NICU, almost immediately after birth, helping to increase the quality of life and improve care for newborns, by assisting in the early detection of health issues, enabling at-risk babies to grow into healthy children,” CEO Uri Rapoport said in a press release

The system allows for urgent access to the neonates if necessary, with the baby typically able to be removed from the system in less than 30 seconds, according to a press release.

Aspect Imaging’s Embrace neonatal MRI system is designed to be placed inside an NICU environment and does not require that devices or implants in close proximity be “MR Conditional” or “MR Safe” as the system is fully enclosed and shielded, according to a press release.

“Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges. Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population,” FDA CDRH pediatrics & special populations chief medical officer Dr. Vasum Peiris said in a press release.

In April, Aspect Imaging raised $30 million to support the development of its Embrace Neonatal MRI system and a newer, stroke-dedicated MRI system.

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