Frequently Asked Questions

A Transformative Solution For Neuro Imaging Inside the NICU

Want to learn more about the Embrace® Neonatal MRI System? We’ve compiled the following list of the most commonly asked questions to give you more information. If you have additional questions, feel free to contact us via email or call 1-615-522-5375.

Q.

Is Embrace® FDA approved?

A.

Yes, Embrace® received FDA 510(k) approval in July 2017. 

Q.

Is Embrace® CE certified?

A.

Yes, Embrace® received CE certification in October 2017. 

Q.

Where is the system currently installed and what is the rate of use?

A.

The system is currently running on a research base in Jerusalem, Israel. It is in use for an average of twice a week. The system is designed to replace the US, allowing as many as 10 scans a day.

Q.

Are there any limitations regarding the patient’s weight? Size? Age? (Lower and upper limits)

A.

The Embrace® is designed for babies weighing between 1 kg and 4-5 kg, and a maximum head circumference of 38 cm.  This is suitable for more than 95% of the newborn population, from preterm to full term (based on Centers for Disease Control and Prevention, June 2016.)

Q.

How far from the NICU can the system be placed at?

A.

There is no limitation regarding how close the system is to the NICU.  It is designed to be placed without additional shielding. It is designed to be installed inside the NICU.

Q.

How is the temperature of the baby measured?

A.

The temperature of the baby can be measured via an MR Safe surface temperature sensor connected to external MR-conditional (patient) monitor.

Q.

How do we control the temperature inside the baby compartment?

A.

The compartment temperature is controlled via a closed-loop air circulation heating system. The temperature can be set to the desired temperature, between room temperature and up to 36.5°C.

Q.

What is the electrical power requirement?

A.

Unlike conventional superconducting MRI systems, Embrace® has low electrical power requirement. Embrace® only requires single phase 200-220 or 220 -240. VAC, 12A electrical power to the electrical cabinet.  If desired, the rack can be switched off at night for zero electrical power consumption.

Q.

What is the weight of the Embrace® system?

A.

The magnet weighs 5,500 kg

The electrical cabinet weighs 350 kg

The patient bed weighs 180 kg

Q.

Does the magnet require Cryogenic cooling?

A.

No.

Q.

What is the maximum power dissipation?

A.

The maximum power dissipation is less than 2.7 KW.

Q.

Can we program our own sequences?

A.

The system includes the basic sequences, such as SE, FSE GRE DWI. All sequence parameters can be adjusted by the application specialist.

Q.

Which sequences are available? What are the imaging capabilities of this device?

A.

The following sequences are available:

  • Spin Echo (SE)
  • Fast Spin Echo (FSE)
  • Gradient Echo (GRE: 2D, 3D)
  • Diffusion weighted images ADC map via spin echo

A typical protocol set for diagnostic purposes includes the following protocols:

  • 2D T1W SE
  • 2D T2W FSE
  • 3D T1W GRE
  • ADC map Single Shot Splice

Q.

What is the typical time for a scan?

A.

  • A typical scan time for diagnostic purposes is ~ 20 minutes
  • Scan time of 2D sequences (SE, FSE) is ~ 3 minutes
  • Scan time of 3D sequences (3D GRE) is ~ 5 minutes
  • Scan time of ADC map sequences is ~ 7 minutes
  • Scan time may change in case the number of slices is increased (which may require increasing the TR), or if more averages are needed to increase SNR
  • The entire procedure – from initial preparation, through scanning, until the patient is returned to bed – typically takes less than an hour.

 

Q.

What is the maximum imaging resolution?

A.

In principle, it is possible to acquire 2D and 3D sequences with a resolution of 0.3 mm. For clinical purposes, the typical resolution parameters for the neonatal brain are as follows:

  • 2D sequences (FSE, SE): 0.8 x 0.8 x 3 mm3
  • 3D sequences (GRE): 1 x 1 x 1 mm3
  • ADC map: 2 x 2 x 4 mm3

Q.

Do you have an array coil? Parallel imaging?

A.

The system has one transmit-receive linear coil.

Q.

How does the image quality compare to clinical scanners?

A.

The system compares the images from the Embrace® system to a 1.5 Tesla commercial scanner. The results show comparable image quality, suggesting an equal level of clinical diagnostic efficacy.

Typical T1 images: Left: 1.5 Tesla Siemens Aera Right: Tesla Embrace System

Q.

How are the images sent to PACS? Do you have MWL?

A.

The MR Technology station is very similar to the full-body MRI, and the system supports Modality Work List, and multiple PACS servers.

Q.

How noisy is it?

A.

  • The acoustic noise outside the magnet, inside the MRI room, does not exceed 71 dBA (peak) and 69 dBA averaged over time.

  • The maximum acoustic noise during scan inside the patient bed neonatal compartment does not exceed 87 dBA peak and 85 dBA averaged over time.

Q.

Do we need MRI-compatible patient monitors?

A.

Yes. In order to monitor the infant’s vital parameters during the MRI scan, it is necessary to use MRI-compatible patient monitors (for SPO2, ECG and heart rate information).

Q.

Can we image intubated babies?

A.

Yes. The RF head coil is designed with an opening in the mouth area to allow imaging of intubated babies. Additionally, the patient bed incorporate routing mechanisms which allow safe tube and line management and prevent dragging, pinching and twisting (see below).

Q.

Is the system intended for an intubated patient? Do we need a special ventilation machine?

A.

Yes. The RF head coil is designed with an opening in the mouth area to allow imaging of intubated babies. Additionally, the patient bed incorporate routing mechanisms which allow safe tube and line management and prevent dragging, pinching and twisting (see below).

Q.

Can we see the baby during the scan?

A.

Yes. A real-time video display system is used to enable visualization of the infant’s face while in the magnet.  This allows clinicians to easily see moving, crying or exhibiting any other signs of distress etc.

Q.

What if the baby moves?

A.

If the baby moves, it can be easily taken out of the MRI system. In such a case, we remove the patient bed from the magnet, take out the baby and feed again, and once asleep, reposition the baby for scanning.

Q.

What is the maximum age and weight of a baby that can be imaged?

A.

The maximum weight for a baby is 4.5 kg, with a head circumference of no larger than 38 cm. This is suitable for more than 95% of the newborn population – from pre-term to full term (based on Centers for Disease Control and Prevention, June 2016).

Q.

Will the MRI help make clinical treatment decisions?

A.

In a retrospective study published in 2014, the clinical and radiological aspects of 129 neonatal MRI examinations during a 3-year period were analyzed. MR-based changes in clinical management were initiated in 58% of cases. The most common change in management was an influence on the initiation or termination and choice of long-term anticonvulsive therapy or anticoagulation, operative decision-making, or antibiotic treatment [Z. Rona et al European journal of pediatric neurology 1 4 (2010) 410-417].

Q.

What makes Embrace® different from other scanners?

A.

The Embrace® Neonatal MRI System is designed specifically for imaging of the neonatal head. 

In summary Embrace is:

  • Quiet
  • Easy to operate
  • Can be placed in the NICU
  • Does not require a special safety zone or an RF-shielded room, 
  • Provides the patient with a temperature-controlled environment

The Embrace® Neonatal MRI system has an integrated, temperature-controlled patient bed designed for neonatal patients. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds.

Q.

Can the system image heart/lungs?

A.

The Embrace® system is currently indicated to image the neonatal head, and is designed with a dedicated RF head coil (linear solenoid).

Aspect Imaging Ltd.
3200 West End Avenue, Suite 500
Nashville, TN 37203

For Inquiries:
Call: 1-615-522-5375
Email:
info@embracemri.com

         

About Aspect Imaging:

Aspect Imaging is a global leader in the design and development of compact, MR imaging systems for Pre-Clinical and Medical applications. Through state-of-the-art technology, Aspect Imaging offers innovative point-of-care MRI solutions, including the Embrace® Neonatal MRI System, which is designed to facilitate enhanced patient-centered diagnostic capabilities inside the NICU.

For more information, visit our website at www.aspectimaging.com.

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