Recently, an artificial intelligence-guided robot successfully performed a laparoscopic surgery to connect two ends of an intestine in four pigs, without any human intervention. And according to the researchers involved, the robot surgeon produced “significantly better” results than humans. Though such an accomplishment is astonishing and signals the inevitable rise of fully autonomous medical robots, it is important to remember that the results generated by artificial intelligence are only as good as the information used to train it.
Continue Reading The Risk of Clinical Data Collection Biases In Fully Autonomous Medical Robots
Studies
The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use
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 procedures or in the prevention or treatment of cancer has not been established.” This action came after the Agency reviewed certain literature suggesting that robotically assisted devices were being used “off-label” in cancer treatment. Incidents like this raise a very important question: How can a company avoid or minimize liability in the event of off-label use?
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Can Robot-Assisted Surgery Be a Pain?
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.
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Will the Rise of the Machine Mark the Fall of Med Mal?
Recently, James Ryan Morales from HealthAim reported on a new study at Children’s National Medical Center in Washington involving the Smart-Tissue Autonomous Robot (STAR) Project. In the study, a supervised autonomous robot performed soft-tissue surgery on a pig’s bowel, demonstrating that robots can now perform surgical operations with very minimal human supervision. It is, therefore, only a matter of time before fully autonomous surgical robots make their way into operating rooms across the country. And so, this begs the question: Will patients still be able to sue their human physicians for injuries allegedly sustained while under an autonomous surgical robot’s scalpel?
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Intuitive Surgical Invests in Robotic-Assisted Surgery Training
Hot off the heels of a recent study linking robotic surgery to negative patient outcomes, Intuitive Surgical—the global leader in robotic-assisted, minimally invasive surgery, and manufacturer of the da Vinci® Surgical System—announced that it “awarded simulator grants to five top U.S. medical centers to advance the field of training for robotic-assisted minimally invasive surgery.”
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Is Robotic Surgery Getting a Bad Rap?
A recent study and a growing number of lawsuits would have us believe that injuries and deaths during robotic surgery are due to failures with the robotic devices. But there is much more to those claims than meets the eye.
Continue Reading Is Robotic Surgery Getting a Bad Rap?