B-Right AI Platform is a marketing term encompassing all BrightHeart's "B-Right" solutions. 

Please check the regulatory information about each medical device.

USA

B-Right Views Fetal Heart V1 is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound examinations. The device is a Class II FDA-cleared (K251456) medical device for use by healthcare professionals only. For more information on precise indications for use, warnings, and limitations of the device, please refer to the 510(k) summary available on the FDA's website or the instructions for use for more information. 

B-Right Screen Fetal Heart V1 is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams. The device is a Class II FDA-cleared (K252294) medical device for use by healthcare professionals only. For more information on precise indications for use, warnings, and limitations of the device, please refer to the 510(k) summary available on the FDA's website or the instructions for use for more information.

EU/EEA

B-Right Views Fetal Heart V1 is a medical device for use by healthcare professionals only. The device is a stand-alone software medical device intended to assist healthcare professionals in conducting fetal ultrasound examinations by providing adjunct information to be used in conjunction with clinical evaluation that is part of standard clinical practice and should not replace standard of care management. See the instructions for use for more information. The device is a Class IIa CE marked (Notified Body: 3022) medical device manufactured by BrightHeart - 7-11 Boulevard Haussmann, 75009 Paris, France.

B-Right Screen Fetal Heart V1 is a medical device for use by healthcare professionals only. The device is a stand-alone software medical device intended to assist healthcare professionals in the review of the fetal anatomic ultrasound examinations by providing adjunct information to use in conjunction with clinical evaluation that is part of standard clinical practice and should not replace standard of care management. See the instructions for use for more information. The device is a Class IIa CE marked (Notified Body: 3022) medical device manufactured by BrightHeart - 7-11 Boulevard Haussmann, 75009 Paris, France.

Worldwide

B-Right Views Fetal Heart V1 and B-Right Screen Fetal Heart V1 are for use only in countries with regulatory authorization: please contact us for more information.

B-Right Views V2 is under development and not commercially available in any country and includes extensions of other anatomy such as brain and new features.

Last updated on June 23rd, 2026.