Breaking News: Monogram Technologies Makes Major Progress with FDA – Exciting 510k Submission Update!

Management Anticipates That it has Sufficiently Addressed the FDA’s Concerns to Mitigate the Need for a Clinical Data Request

Management Anticipates a Comprehensive AIR Response in Q1 2025

AUSTIN, TX / ACCESSWIRE / December 18, 2024 / Monogram Technologies Inc. (NASDAQ:MGRM) (“Monogram” or the “Company”), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today provided an update from its Submission Issue Request (SIR) meeting with the U.S. Food and Drug Administration (“FDA”) on December 17, 2024, regarding its 510(k) premarket filing submission for the Company’s mBôs TKA System (the “Application”). The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review.

Monogram Technologies has recently made significant progress in its dealings with the FDA regarding its 510(k) premarket filing submission for its mBôs TKA System. The FDA meeting that took place on December 17, 2024, was an important milestone for the company, as it provided an opportunity for Monogram to address any concerns and queries raised by the regulatory body.

With management anticipating that they have adequately addressed the FDA’s concerns, there is hope that the need for a Clinical Data Request will be mitigated. This is a positive development for Monogram, as it indicates that the company’s submission is on the right track and may not require additional data to be supplied.

Furthermore, as Monogram gears up for a comprehensive AIR (Additional Information Request) response in Q1 of 2025, the company is working diligently to ensure that all necessary information and documentation are in place to satisfy the FDA’s requirements. This proactive approach demonstrates Monogram’s commitment to meeting regulatory standards and gaining approval for its innovative mBôs TKA System.

The mBôs TKA System is a cutting-edge technology that utilizes artificial intelligence and robotics to enhance the precision and effectiveness of orthopedic surgery. By focusing on improving human health through technological advancements, Monogram Technologies is at the forefront of innovation in the medical field.

How will this affect me?

As a potential consumer of healthcare services, advancements in technology such as the mBôs TKA System can impact you positively. This innovative system has the potential to improve the outcomes of orthopedic surgeries, resulting in better recovery rates and overall patient satisfaction. By addressing the FDA’s concerns and moving closer to approval, Monogram Technologies is paving the way for the future of minimally invasive surgical procedures.

How will this affect the world?

The progress made by Monogram Technologies with the FDA is not only significant for the company but also for the medical industry as a whole. By pushing the boundaries of technology and innovation, companies like Monogram are driving forward the evolution of healthcare practices. The approval of the mBôs TKA System could revolutionize orthopedic surgery and set a new standard for the integration of AI and robotics in medical procedures.

Conclusion

In conclusion, Monogram Technologies’ recent progress with the FDA signals a step in the right direction for the company and the healthcare industry. With anticipation building for a comprehensive AIR response in Q1 of 2025, Monogram is on track to potentially revolutionize orthopedic surgery with its mBôs TKA System. The implications of this advancement extend beyond just the company itself, as it has the potential to improve surgical outcomes and patient care on a global scale.