Magic Leap, the storied unicorn developing enterprise AR headsets, announced at CES 2023 that its flagship device Magic Leap 2 earned a certification that clears it for use in the operating room.

The company first intimated it had pursued IEC 60601-1 certification at SPIE’s XR conference in January 2022, however the news largely went unreported since the information was presented in a single slide at the conference.

At AMD’s CES 2023 keynote, Magic Leap CEO Peggy Johnson confirmed Magic Leap 2 has indeed obtained IEC 60601-1 certification for its flagship AR headset.

As explained by TÜV Rheinland, the IEC 60601-1 certification specifies a device that is “intended to diagnose, treat, or monitor a patient under medical supervision and, which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such an energy transfer to or from the patient.”

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Magic Leap says this certification allows Magic Leap 2 to be used both in an operating room as well as in other clinical settings, allowing medical professionals such as surgeons to focus on the patient and not have to refer to 2D screens.

By and large, this gives software developers a non-inconsequential inroad into gaining FDA certification for apps that could be used during surgery, and not just for pre-surgical training.

One such Magic Leap partner, SentiAR, is currently under review by the FDA for its app which connects physicians to live clinical data and images, allowing them to do operations such as navigating a catheter through blood vessels of the heart using a 3D map of a patient’s heart and the location of the catheter in real time.

Founded in 2010, the Plantation, Florida-based company initially exited the gate with consumer ambitions for its first AR headset, Magic Leap 1 (previously styled ‘One’). After awkwardly straddling the segment with its $2,300 AR headset, the company made a decisive pivot in mid-2020 when co-founder Rony Abovitz announced he would be stepping down as CEO, positioning the company to reprioritize its future devices away from consumers. It has since released Magic Leap 2, which is largely targeted at enterprise.

The well-funded company, which has amassed $4 billion in funds to date, has recently taken on $450 million from Saudi Arabia’s sovereign wealth fund, giving the country a majority share in the US-based augmented reality company.

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Scott Hayden
Well before the first modern XR products hit the market, Scott recognized the potential of the technology and set out to understand and document its growth. He has been professionally reporting on the space for nearly a decade as Editor at Road to VR, authoring more than 4,000 articles on the topic. Scott brings that seasoned insight to his reporting from major industry events across the globe.
  • kool

    Pretty cool and scary!

  • another juan

    Very nice, but I’d rather not be an unconscious early adopter

  • Andrew Jakobs

    I just wonder if the screens aren’t making the working area too dark. But in the near future of tye glasses can be really clear like normal glasses, I certainly think this is the way forward, especially with realtime overlays and information. AI will be a good help and hopefully even in the near future replace human surgeons, so going into surgery is much shorted and faster and healthcare can finally be much MUCH cheaper and available to anyone.

    • Guest

      Cheaper, magic-ier, or AI-ier! What sort of surgery do you deserve???

  • david vincent

    Doctors must learn how to wear googles first (see the hilarious photo)

    • Adrian Jamrozik

      Those are well fitted – look at the strap overhead.ML2 gives you app that ensures good fit before you start using system.

  • Ad

    The Saudi Arabian regime owning them needs to be something disqualifying. We’re talking about a state sponsor of terror, currently bombing one of their neighbors to hell, a place where dissidents have been publicly beheaded. Why is XR just escalating in terms of the people who own these companies? There are conversations to be had about bytedance being located in china and having bad data practices but this is just straight up if Putin wore a crown and bought this company.

    • Bob

      No politics in here please.

      • Ad

        This is literally a political story, I’m not a fan of overlooking beheadings, terrorism, and brutal wars because it offends your gamer sensibilities to mention them.

        • Bob

          “This is literally a political story”

          No it isn’t. It’s about an XR based company certifying their product(s) to be used for medical applications. Are we reading the same article here? Or is a narrative to suit a personal agenda being projected here?

          Also – please refrain from labelling others if you don’t know them. It’s exceptionally rude and disrespectful.

          • Ad

            “It’s exceptionally rude and disrespectful.”

            It’s far more rude to act like a spoiled video game obsessed child when adults are talking.

          • Bob

            No it has nothing to do with “video games” and certainly nothing to do with myself. I think you’re taking this far too personally for an unknown reason.

            This is an XR website where discussion is about XR topics. You came into the comments section with a politically charged statement which is irrelevant to the nature of the article. There’s a plethora of other publications and websites better suited for this if you wish to raise awareness of political agendas. Certainly not in here.

            By your logic every topic can be made political including an obscure article about teeth brushing. News flash: It’s only political if you make it so.

            Finally, I’m not prepared to waste further time on this since it’s clearly a futile effort to engage in a civilized conversation with you.

          • Ad

            You’re not civilized for trying to suppress relevant information.

    • Stu Woody

      I have to agree with Ad on this one. When I heard about this majority share holding I made a conscious and personal choice to cross the brand off my list of options. How short our memories, remember that Saudi chap called Bin Laden? Well you can guarantee there’s very few steps if any between his sympathizers and these investors. I have no problem with forums like this being used to raise awareness be it brand ethics, technical issues, or product experience. ESG is part of the value chain whether we like it or not.

      • Ad

        His family are still well connected billionaires in the country and the royal family has close ties to people like him across the middle east who still hurt a lot of people.

  • Jim Cherry

    I had forgotten magic leap had pivoted away from celebrity’s to industrial guess theyre taking the ibm rout to irrelevance ;}