Regulatory Approvals

The US Food and Drug Administration (FDA) has granted Endotronix’s Cordella sensor Investigational Device Exemption (IDE) for a second multicentre study, meaning the sensor...

Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration. The proposed...

The device allows patients to administer their therapy subcutaneously from home or in the clinic to increase flexibility in their daily lives. The US Food...

SeaStar Medical has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its patented cell-directed Selective Cytopheretic Device (SCD) to treat...

The US Food and Drug Administration (FDA) has granted ReGelTec an investigational device exemption (IDE) for the company’s HYDRAFIL system. The device contains a polymer...

Galen Robotics, Inc., a leading medtech company specializing in advanced robotic surgical systems, today announced U.S. Food and Drug Administration (FDA) De Novo classification...

HoneyNaps has received approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI) sleep disease analysis algorithm, SOMNUM. The new software surpasses conventional...

Tyber Medical has secured approval from the US Food and Drug Administration (FDA) and European Union Medical Device Regulation (EU MDR) for its implantable K-Wires and...

The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain...