Mendaera's FDA Clearance Marks New Era in Robotic Needle Delivery

Mendaera, a Silicon Valley-based medical technology company, has received FDA clearance for its innovative handheld robotic needle delivery system, the Focalist. This breakthrough device aims to revolutionize some of the most common medical procedures, potentially impacting up to 200 million procedures annually.

Focalist System: A Game-Changer in Precision Medicine

The Focalist system, weighing about as much as a mobile phone, attaches to a handheld ultrasound probe and utilizes real-time imaging to guide needle placement. The device's touchscreen interface provides users with a clear indication when the needle is correctly aligned and ready for insertion, while also tracking its depth.

Mendaera's technology has shown promising results in improving first-stick accuracy across a range of users, from seasoned specialists to novice practitioners. In comparative studies, the Focalist system demonstrated enhanced performance for all users, with beginners reportedly outperforming experienced interventional radiologists and emergency medicine specialists in certain tasks.

Commercial Launch and Future Developments

Mendaera plans a limited commercial launch of the Focalist system in 2025, initially focusing on urological procedures such as percutaneous nephrolithotomy for large kidney stones. The company aims to expand nationwide across various medical specialties by 2026.

Looking ahead, Mendaera is developing artificial intelligence programs to automatically highlight anatomical features during procedures. The company is also working on telehealth connectivity, which would enable remote observation and guidance by specialists during needle placements performed by front-line clinicians.

Financial Backing and Industry Impact

In September 2024, Mendaera secured $73 million in Series B funding led by Threshold Ventures, with additional support from Lux Capital, PFM Health Sciences, and Frederic Moll, founder of Intuitive Surgical and Auris Health. This substantial investment underscores the industry's confidence in Mendaera's potential to transform routine medical procedures.

Josh DeFonzo, Mendaera's co-founder and CEO, emphasized the company's mission: "Our goal is to ensure that these procedures are delivered safely and efficiently across the healthcare system by enabling more providers with the confidence needed to perform these techniques. Robotics have been shown to increase provider capabilities in complex procedures, and we intend to demonstrate that the same can be true in everyday care."

As Mendaera prepares to introduce the Focalist system to the market, the medical community eagerly anticipates the potential impact of this technology on patient care, procedural efficiency, and the broader landscape of minimally invasive interventions.