Regulatory Approvals

FDA grants Endotronix’s Cordella sensor IDE for second heart failure study

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...

FDA rule change sees Laboratory Developed Tests regulated as medical devices

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...

FDA approves Empaveli injector for PNH patients

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 gets FDA breakthrough status for Selective Cytopheretic Device

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...

FDA approves IDE for HYDRAFIL system in degenerative disc disease study

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. Secures De Novo Grant for Galen ES, World’s First Cooperatively Powered Robotic Surgical Assistant Platform for Ear, Nose, and Throat (ENT)...

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’ AI sleep disease analysis algorithm receives FDA approval

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 receives approval for K-Wires and Steinmann Pins

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...

FDA Updates Breakthrough Devices Program Guidance

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...
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