Microbot is also working to engage additional medical centres for the trial. Credit: Dmitry Kalinovsky / Shutterstock.

Pre-clinical medical device company Microbot Medical has obtained US Food and Drug Administration (FDA) approval to proceed with its pivotal human clinical trial for its LIBERTY robotic endovascular surgical system.

The trial is a significant step in the investigational device exemption (IDE) application for the company’s LIBERTY system.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Set to take place in the US, the clinical study will be conducted in collaboration with a leading academic medical centre, which has already signed a clinical trial service agreement with Microbot Medical.

Efforts are underway to engage additional prominent medical centres for the trial. Furthermore, the company is completing the necessary biocompatibility tests stipulated by its IDE application.

The LIBERTY system is designed to help physicians improve surgeries related to endovascular procedures.

See Also:

It eliminates the need for large and expensive capital equipment and reduces physician’s strain and radiation exposure.

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.

Microbot Medical CEO, president and chairman Harel Gadot said: “The recent authorisation by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology.

“It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe.”

In June 2023, Microbot secured funding worth NIS1.62m ($440,000) from the Israel Innovation Authority to further develop its manufacturing process for the LIBERTY system.