Product Regulatory Information

B-Right AI Platform is a marketing term encompassing all BrightHeart's "B-Right" solutions. Please check the regulatory information about each medical device below.

USA

B-Right Views Fetal Heart V1 is a machine learning-based review 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 CHDs screening 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 V2 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 anatomic 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, B-Right Views V2 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 only commercially available in the european countries declared in EUDAMED. B-Right Views V2 includes new features that are not yet commercially available in the USA.

Last updated on September 2nd, 2026.