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Suturion receives FDA clearance

The US Food and Drug Administration (FDA) has granted clearance for the surgical device SutureTOOL.
This marks a significant milestone toward the launch of this device, aiming to improve patient outcome, secure surgical precision and reduce healthcare costs, the company states.
“The FDA’s recognition is a milestone for Suturion and means that our device soon will be able to contribute to reducing the risk of patient complications following open abdominal surgery. The U.S. will be the first market where SutureTOOL is launched, and our aim is that it will be available already this spring,” says Paan Hermansson, CEO of Suturion.
The plan is to launch SutureTOOL on the US market this spring 2025.
Safer Technologies Program
In the fall of 2023, Swedish Suturion was accepted into the FDA’s Safer Technologies Program (STeP). The program is designed to accelerate the approval process for products that will increase patient safety compared to alternatives on the market.
A very advanced sewing machine
SutureTOOL is a suturing device designed to increase patient safety. It can be compared to a very advanced sewing machine that allows surgeons to perform abdominal wall closure in a standardized, efficient, and safe way. By minimizing complications, it also eases the burden on the healthcare system, describes the company.
Founded in Lund
Suturion was founded 2018 in Lund, Sweden, by surgeon Gabriel Börner. Last year, the company secured an additional SEK 24 million in a funding round to prepare for the commercial launch.
Published: February 3, 2025
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