Bot Image, Inc. Celebrates CE Mark Certification for AI Software

Bot Image, Inc. Celebrates CE Mark Certification for AI Software

This certification opens new doors for advanced diagnostic solutions in Europe.

Bot Image, Inc., a pioneer in AI-driven diagnostic imaging, has proudly announced that their flagship product, ProstatID®, has achieved CE certification under the rigorous European Union Medical Device Regulation. This accomplishment marks a significant milestone in the company's ongoing efforts to broaden its global footprint.

The CE certification was awarded by Intertek Medical Notified Body AB, confirming that Bot Image's comprehensive Quality Management System and product design adhere to all essential safety and performance standards set forth by the EU.

With this certification, Bot Image's innovative software gains access to the European market, where it aims to enhance the accuracy of prostate MRI interpretations, fostering improved healthcare outcomes.

Mike "Bing" Crosby, Chief Commercial Officer at Bot Image, expressed enthusiasm regarding this achievement: "This certification is vital in our commitment to ensuring early and precise detection of prostate cancer for both clinicians and patients across the globe. With FDA clearance achieved, we are now prepared to make ProstatID® available in European healthcare systems at a crucial time."

ProstatID® leverages cutting-edge artificial intelligence technology to streamline the identification, quantification, and classification of prostate lesions from MRI scans. By enhancing diagnostic accuracy and decreasing variability in interpretation among different radiologists, ProstatID® integrates seamlessly into existing clinical workflows and aids in decision-making regarding biopsies through comprehensive lesion mapping.

This new certification also establishes the utility of ProstatID® in Active Surveillance practices. It provides a visual record of detected lesions, tracking changes in size and risk over time, which can significantly assist healthcare providers in monitoring patients effectively.

Dr. Randall W. Jones, the CEO of Bot Image, emphasized the importance of this accomplishment, stating, "Securing the CE Mark under the new MDR standards showcases our unwavering dedication to quality, regulatory compliance, and the safety of patients. Our European partners can confidently adopt ProstatID®, knowing it meets the highest regulatory benchmarks globally."

Following this successful certification, Bot Image is poised to commence onboarding European distributors and clinical partners as part of its strategy to accelerate the deployment of ProstatID® across hospitals and diagnostic centers in the region.

About Bot Image, Inc.

Bot Image, Inc. develops leading-edge AI-driven diagnostic imaging solutions aimed at enhancing radiologic accuracy and standardization. ProstatID®, their flagship offering, is recognized as the first software of its kind to receive both FDA clearance and CE certification for interpreting prostate MRI scans, thereby paving the way for more timely and accurate detection of significant prostate cancer cases.

Frequently Asked Questions

What is ProstatID®?

ProstatID® is an AI software developed by Bot Image, Inc. for interpreting prostate MRI scans, designed to enhance accuracy in detecting prostate cancer.

What does CE certification mean for ProstatID®?

CE certification allows ProstatID® to be marketed and used in Europe, signifying compliance with the EU's safety and performance standards.

Who awarded the CE certification?

The CE certification was awarded by Intertek Medical Notified Body AB, ensuring that Bot Image's quality management and product design meet rigorous EU criteria.

Why is this certification significant?

This certification represents a major step in Bot Image, Inc.'s expansion efforts, allowing them to provide cutting-edge healthcare solutions to clinicians and patients across Europe.

What does this mean for patient care?

The certification enables more healthcare professionals to use advanced AI software, improving the detection and monitoring of prostate cancer, which can lead to better patient outcomes.

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