News

Johnson & Johnson Seeks FDA Approval for Robotic Surgery Software

• By John K. Waters
• 10/09/2024

Johnson & Johnson MedTech has submitted a 510(k) filing to the U.S. Food and Drug Administration (FDA) for the latest software update to its Monarch surgical robotics platform. The filing is another step in the company's ongoing push to revolutionize minimally invasive procedures with cutting-edge, robotic-assisted technology.

The Monarch platform, originally designed to provide bronchoscopic visualization and access to the airways of adult patients, offers a unique combination of flexibility and precision. This advanced robotic system is used in both diagnostic and therapeutic procedures, targeting conditions such as lung cancer, which often presents in hard-to-reach areas of the lungs. By enabling the use of minimally invasive technology, Monarch aims to improve outcomes for patients by detecting and treating small, peripheral lung nodules earlier than traditional methods allow.

Johnson & Johnson's submission to the FDA represents a crucial upgrade to the Monarch system, the company said in a statement. The new software includes advanced integration with C-arm imaging technology, a significant enhancement designed to further improve the accuracy and effectiveness of procedures. This new capability aligns with the company’s broader strategy of refining its surgical robotics platform to meet the evolving needs of clinicians and patients alike.

"We are working to deliver meaningful updates that customers need today and exploring innovative options to transform patient care in the future," Johnson & Johnson MedTech wrote in a post on LinkedIn.

Johnson & Johnson got into the surgical robotics business with the acquisition in 2019 of Auris Health, the original developer of the Monarch platform, for $3.4 billion. This move gave J&J a foothold in the competitive and rapidly growing market for robotic-assisted surgery, which has been driven by the demand for minimally invasive procedures with fewer complications and quicker recovery times.

Since then, the Monarch platform has achieved a series of regulatory clearances. In addition to its initial FDA clearance for bronchoscopic procedures, the platform received approval in 2022 for use in endourological procedures, broadening its utility beyond lung care. By the end of 2023 Monarch had become the first minimally invasive robotic system to be approved for peripheral lung procedures in China.

The latest software update is expected to further strengthen Monarch’s position as a leading solution in robotic-assisted surgery, with a particular emphasis on its ability to perform complex lung procedures with greater precision and efficiency. This is increasingly critical in healthcare, as providers seek to improve early detection and treatment options for conditions like lung cancer, where time and accuracy can significantly impact patient outcomes.

Johnson & Johnson’s pursuit of innovation in robotic-assisted surgery comes as part of a broader shift in the healthcare industry toward technologies that reduce patient recovery times, minimize complications, and enhance the precision of surgical procedures. The integration of advanced imaging technologies, such as the C-arm in the Monarch system, provides clinicians with the tools they need to perform these complex procedures with unprecedented accuracy.

This latest 510(k) submission represents not just a technical upgrade, but a continuation of J&J’s strategy to redefine the future of surgery, the company says. Robotic-assisted surgery platforms like Monarch are increasingly seen as the next frontier in healthcare, offering a blend of human skill and machine precision that can improve both the patient and clinician experience.

As Johnson & Johnson moves forward with its latest FDA submission, it finds itself in an increasingly competitive market. Other major players, such as Intuitive's Da Vinci system and Medtronic’s Hugo robotic surgery platform, are also vying for leadership in this space. With FDA approval potentially on the horizon, J&J's new Monarch software release could pave the way for more widespread adoption of robotic-assisted technology in the treatment of lung conditions.

In the coming months, the industry will be watching closely to see how the FDA responds to this latest filing and what the future holds for the Monarch platform as it continues to evolve and reshape the landscape of minimally invasive surgery.