Mendaera Receives FDA 510(k) Clearance for Innovative Handheld Robotic System

Robotics Firm Mendaera Secures Funding, Expands Partnerships to Revolutionize Interventional Procedures

San francisco, CA – Mendaera, a healthcare robotics company focused on precision needle placement, is rapidly expanding its reach through strategic partnerships and notable funding rounds, aiming to bring robotic assistance to a wider range of medical procedures. the company’s technology is designed to enhance the safety and efficiency of interventions like biopsies, vascular access, and organ access.

mendaera recently closed a $73 million Series B funding round, building on a previous $24 million Series A raise led by Lux Capital in 2023. These funds are fueling the company’s efforts to scale robotics and artificial intelligence integration into mainstream medical practice, including the establishment of a production facility and pursuit of FDA clearance.”Precise placement of needles…is a very challenging, but foundational technique that underpins most patient care journeys,” stated Josh DeFonzo, Mendaera’s cofounder and CEO. “Our mission is to ensure that these procedures are delivered safely and efficiently…by enabling more providers with the confidence needed to perform these techniques.”

The company is actively forging collaborations to broaden its capabilities. In April, Mendaera partnered with Cook Medical, integrating Cook’s EchoTip technology into its instrumentation. This collaboration focuses on developing advanced tools for needle-based interventions, specifically in urological procedures.

Further expanding its ecosystem, Mendaera also established compatibility between its handheld robotic platform and EchoNous’ Kosmos portable ultrasound machine in 2024.

Last year, Mendaera acquired Avail Medsystems’ telepresence technology, a move designed to improve patient access to interventions and enhance care delivery within healthcare systems.

Mendaera believes robotics can significantly increase provider capabilities, not just in complex procedures, but in everyday care, and is positioning itself to lead this transformation in interventional medicine.

How does the Mendaera Robotic System’s handheld design compare to conventional robotic surgery systems in terms of surgeon learning curve and control?

What is the mendaera Robotic System?

Mendaera, a medical robotics company, has announced a notable milestone: FDA 510(k) clearance for its groundbreaking handheld robotic system. This clearance signifies that the device is substantially equivalent to legally marketed predicate devices and can be commercially distributed in the United States. The system is designed to enhance surgical precision and control for a variety of procedures, initially focusing on otologic (ear) and neurotologic (inner ear) surgeries. This represents a leap forward in robotic surgery, offering surgeons a new tool for minimally invasive procedures.

Key Features and Technology

The Mendaera system isn’t your typical large, fixed robotic arm. it’s a compact, handheld device offering several distinct advantages:

Handheld Design: Allows surgeons to maintain a natural feel and intuitive control during procedures. this contrasts with traditional robotic systems that often require a learning curve due to their remote operation.

Micro-Robotics: incorporates miniature robotic technology, enabling precise movements within confined surgical spaces. This is notably crucial in delicate ear surgeries.

real-time Control: Provides surgeons with immediate feedback and control, enhancing accuracy and minimizing tissue trauma.

Integrated Visualization: Frequently enough paired with advanced visualization systems (endoscopes, microscopes) to provide a clear view of the surgical site.

Sterile Disposable Instruments: Utilizes sterile, single-use instruments to maintain a high level of hygiene and reduce the risk of infection.

The core technology revolves around miniaturized actuators and sensors, coupled with sophisticated control algorithms. This allows for tremor filtration, motion scaling, and precise positioning – all critical for successful minimally invasive surgery.

Applications in Otology and Neurotology

The initial FDA clearance focuses on applications within otology and neurotology. This includes procedures such as:

Chronic Ear Infections: Precise removal of infected tissue and reconstruction of the middle ear.

Cholesteatoma Removal: Surgical removal of abnormal skin growth in the middle ear. The robotic system’s precision can definitely help preserve surrounding structures.

Cochlear Implantation: Assisting in the delicate placement of cochlear implant electrodes.

Mastoidectomy: Surgical removal of the mastoid air cells, frequently enough performed to treat chronic ear infections.

Stapedectomy: A procedure to correct hearing loss caused by otosclerosis.

These procedures often require extreme precision due to the proximity of critical structures like the facial nerve and inner ear balance organs.The Mendaera system aims to improve surgical outcomes and reduce the risk of complications in these sensitive areas. Ear surgery robotics is a rapidly evolving field, and this clearance positions Mendaera as a key player.

Benefits of the Mendaera System for Surgeons and Patients

The Mendaera handheld robotic system offers a range of potential benefits:

For Surgeons:

Enhanced Precision: Improved accuracy and control during complex procedures.

Reduced Fatigue: The system can help minimize hand tremors and strain,particularly during long surgeries.

Improved Visualization: Integration with advanced imaging technologies provides a clearer view of the surgical site.

Greater Dexterity: Access to hard-to-reach areas with increased maneuverability.

For Patients:

Minimally Invasive Procedures: Smaller incisions, leading to less pain and faster recovery times.

Reduced Risk of Complications: increased precision can minimize damage to surrounding tissues.

Improved Surgical Outcomes: Perhaps leading to better hearing preservation and long-term results.

Shorter Hospital Stays: Faster recovery can translate to reduced hospital stays.

The 510(k) Clearance process: A Closer Look

The FDA 510(k) clearance pathway is a common route for medical device approval. It requires demonstrating that the new device is “substantially equivalent” to a legally marketed predicate device – meaning it has similar intended use and technological characteristics.

The process typically involves:

1. Device Description & Intended Use: Detailed documentation outlining the device’s features and how it will be used.
2. Performance Testing: Data demonstrating the device’s safety and effectiveness.This includes bench testing, animal studies, and potentially clinical trials.
3. Comparison to Predicate Device: A thorough analysis showing how the Mendaera system is similar to and different from existing devices.
4. FDA Review: The FDA reviews the submitted data to determine significant equivalence.

Receiving 510(k) clearance is a rigorous process, and mendaera’s success highlights the quality and innovation of its technology.FDA clearance medical devices undergo thorough scrutiny to ensure patient safety.

Future Developments and Expansion

Mendaera is actively exploring expanding the applications of its robotic system beyond otology and neurotology. Potential future areas of focus include:

Head and Neck Surgery: Precise tumor removal and reconstruction.

Transoral Robotic Surgery (TORS): Minimally invasive procedures for accessing and treating tumors in the mouth and throat.

* Rhino-sinus Surgery: improving precision in