Mihai Vrasmasu

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Clinical Robotics Law Journal

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Mihai Vrasmasu

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Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures.  The warning stated, in relevant part, “To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer.” The warning went on to say, “Be aware that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy …
cancer-389921
Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures.  The warning stated, in relevant part, “To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer.” The warning went on to say, “Be aware that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy …
Touch 1
As more and more surgical robots make their way into operating rooms, companies are learning valuable lessons about how their devices function in the real world.  Though many existing design features are proving highly effective, physician response suggests that current systems should evolve to include additional capabilities, like “haptic feedback.”  While discussing what it’s like to perform surgery without it, a UCLA associate professor of electrical engineering recently explained, “You can see what you’re doing, …
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Over the last decade, robotics have revolutionized healthcare. Surgical robots are rapidly making their way into many of our nation’s operating rooms, and are being used in a wide variety of surgeries ranging from gynecological to ocular procedures.  Their popularity stems not only from their relative ease of use, but also from their potential for improved patient outcomes and decreased recovery time. As with any device or product, however, surgical robots and the companies that…
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Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed.  Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or manufacture.  A recent study from Johns Hopkins University may now allow some to argue that surgical robots are also injuring surgeons. …
apple
Though a number of companies manufacture and sell surgical robots in the United States, Intuitive Surgical has been the primary target of product liability lawsuits in recent years. Around 100 such claims have already been filed and at least 700 more are believed to have been placed on the back burner pursuant to a tolling agreement with some plaintiffs’ counsel. To date, only two product liability cases against Intuitive have gone to trial. The jury…
Medical tool
It’s not hard to imagine a time in the not-too-distant future when physicians start using 3-D printing technology to produce tools for their robotic surgery systems that are based on existing copyrighted models but customized to address patient-specific needs. But what happens when the copyright holders of those existing models start attributing depressed bottom lines to unauthorized 3‑D printing? Jesse Camacho and I published an article in Industry Week addressing the issue of how copyright holders…
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In January, I posted regarding the impact of the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015).  In that post I explained that even after Aubin, the consumer expectations test should not be applied in all design defect strict product liability cases because it is still up to the individual trial court judges to decide whether the consumer expectations and risk-utility tests should be given alternatively…
Not too long ago, I had the distinct pleasure of speaking at Shook Hardy & Bacon’s Update of the Law CLE conference in front of about 700 lawyers. Given the overlap in issues between emerging technologies like surgical robotics and 3D printing, I was asked to give a quick 15 minute presentation regarding 3D printing. In the video below you can watch that presentation. In it, I discussed the eight currently available 3D printing methods, how…