FDA Approves Cutting-Edge Surgical Augmented Reality Platform

The US Food and Drug Administration (FDA) has granted 510(k) clearance to SurgicalAR, an augmented reality (AR) platform for use when performing surgery.

Medivis, a medical technology company based in New York City, developed the product and intends to release it commercially throughout the US immediately.

The SurgicalAR platform uses augmented reality, artificial intelligence, and computer vision to provide a visual interface of details that a surgeon would otherwise be unable to see while performing surgery. The platform can potentially reduce surgical costs and increase the probability of positive outcomes for patients.

“Holographic visualization is the final frontier of surgical imaging and navigation,” Osamah Choudhry, MD, a neurosurgeon and Medivis’ founder and chief executive officer, said in a statement.

Christopher Morley, MD, a radiologist and cofounder/president of Medivis added, “Achieving this milestone accelerates our mission to improve surgical precision and safety by allowing surgeons to see the invisible.”

Medivis recently partnered with Verizon and Microsoft and announced over 2 million in funding, primarily from Initialized Capital. They also released their AnatomyX platform for AR medical training in classrooms this year.

In a recent interview with MD Magazine®, Claudette Lajam, MD, an orthopedic surgeon with NYU Langone, expressed excitement for the impending development and progression of augmented reality and telehealth in surgery. But she also tempered expectations, noting that factors such as feedback and follow-up will still be necessary from trained professionals.

"And it also doesn't see the patient postoperatively and understand, well what you do in here is going to turn into something else a year from now," Lajam said. "So, we have a responsibility to learn how to use technologies like robotics, navigation, and now virtual reality is coming more into play with regard to surgery."