Medical device company Precision Biopsy has obtained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to expand the clinical trial of its ClariCore Biopsy System for prostate cancer.

The ClariCore system, fitted with an optical fiber and companion console, conducts spectral analysis of prostate tissue during a prostate biopsy, offering in-vivo tissue classification which reduces the number of core samples to be examined while providing diagnostic information during the biopsy.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Spectral analysis involves the use of light to spot the tissue to provide real-time information which paves the way for timely diagnosis.

"Approximately 200 patients are planned to be included in the three arms of the trial conducted by Precision Biopsy."

The ClariCore Biopsy System uses spectral analysis with a highly predictive algorithm to rapidly classify a normal and a suspicious tissue.

Precision Biopsy’s Cohort A clinical trial will enroll prostate cancer patients in the Transrectal Ultrasound (TRUS) and MR / Fusion arms of its study.

See Also:

It will collect prostate tissue and associated optical signatures to aid the development of ClariCore System’s real-time tissue classification algorithm.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Approximately 200 patients are planned to be included in the three arms of the trial conducted by Precision Biopsy.

Precision Biopsy CEO Amir Tehrani said: “The approval from the FDA marks an important step forward in our efforts to finalise development of the ClariCore Optical Biopsy System and help to improve the biopsy process for patients being evaluated and monitored for prostate cancer, the second-most deadly cancer in men.”