On September 12, we announced that our IGAR robotics system has secured a successful 510(k) clearance from the U.S. Food and Drug Administration (FDA), which applies to this MRI-compatible robot in breast biopsy indications.
Coverage of the announcement appeared across the Medtech media landscape with articles appearing in:
- Fierce Biotech
- +Mass Device
- Surgical Robotics Technology
- Aunt Minnie
- Medical Product Outsourcing
- Imaging Technology News
- Diagnostic Imaging
- Health Imaging
- Medical Device Network
- NS Medical Device Developments
“IGAR’s FDA clearance represents many years of hard work and investment from our team, Dr. Mehran Anvari, and our partners at MDA and the Centre for Surgical Invention and Innovation (CSii),” says CEO Fazila Seker. “It’s gratifying to see the industry validate our achievement in creating the first and only robotic guidance and placement system cleared to work inside an MRI bore.”
IGAR is the first and only robotics system designed to work inside an MRI bore to achieve this regulatory clearance. The MRI suite is among the most challenging hospital environments because the MRI device uses strong magnetic fields and has a confined working area for physicians. The IGAR technology platform may be adapted for future products that could move seamlessly across different care environments, such as from an MRI to a standard operating room or into a physician’s office.
Insight Medbotics has demonstrated IGAR’s safety and efficacy through published clinical studies in breast biopsy. The technology’s other possible applications include targeting other organs and disease indications, along with therapeutic delivery and device placement.
“Partnering with leaders in MRI, AI and therapeutics is the next stage of our journey with the IGAR technology platform,” says Seker. “Combining our deep expertise in robotics with these ecosystem opportunities is how we’ll accelerate targeted care for patients.”