Lung cancer claims more lives each year than any other cancer, making early and accurate diagnosis crucial to improving survival rates. To that end, the U.S. FDA has cleared the integration of Intuitive Surgical Inc.’s Ion endoluminal system and Siemens Healthineers AG’s Cios Spin mobile imaging cone-beam CT imaging technology to enhance robotic lung biopsies.

Ethicon Endosurgery Inc. and Intuitive Surgical Inc. have been sparring in the courts over patents for robot surgery systems for some time, and the U.S. Court of Appeals for the Federal Circuit has ruled on yet another of those disputes.

The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.

Ethicon Endosurgery Inc. has had its hands full protecting a patent for robotic surgical systems, but the U.S. Court of Appeals for the Federal recently delivered some good news. The Federal Circuit affirmed the results of an inter partes review (IPR) of three claims for an endocutter patent, leaving Ethicon with another win in its efforts to sustain a critical patent for the robotic surgical space, and major player Intuitive Surgical Inc. coming out on the short end of the argument.

Intuitive Surgical Inc. benefited from keen interest in resuming surgeries during pandemic troughs and hospitals investing in its Da Vinci robotic system in preparation for a more endemic phase of COVID-19, Intuitive CEO Gary Guthart said in a presentation at the J.P. Morgan 40th Annual Healthcare Conference on Jan. 12. The company’s unaudited preliminary fourth quarter and full year 2021 results also showed strong growth in procedure volumes – 19% year-over-year compared to 2020 and 13% compared to 2019. Still, Intuitive reported that “during 2021, COVID-19 resurgences continued to impact Da Vinci procedure volumes. The impact of the COVID-19 pandemic on the company’s business has, and continues to, differ by geography and region.”

The FDA has posted an advisory regarding robotically assisted surgery (RAS) for mastectomy, but the agency also pointedly noted that it is aware of studies underway for such indications without the appropriate oversight. The FDA did not name Intuitive Surgical Inc. in the notice, but the company nonetheless responded to the FDA statement by confirming the absence of any devices thus approved or cleared. The FDA had previously issued a Feb. 28, 2019, advisory stating that the safety and efficacy of RAS devices for mastectomy and the prevention or treatment of breast cancer had not been established.

Roughly four years after Intuitive Surgical Inc. petitioned for an inter partes review for a patent owned by Ethicon Endo-Surgery Inc., the Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board (PTAB) finding that the first 14 claims in Ethicon’s 9,585,658 patent are invalid. While the fate of two other claims are still up in the air pending remand to the PTAB, the net effect of the hearing was significantly damaging to an Ethicon patent for surgical staplers that has been in place for only four years.

Robotic-assisted surgery-focused Intuitive Surgical Inc. revealed its second-quarter results late July 21, with worldwide Da Vinci procedures falling about 19% vs. the same period of 2019. Driven by this decline, second quarter 2020 instruments and accessories (I&A) revenue fell by 20% to $461 million, vs. $579 million in the second quarter of 2019.

Robotic-assisted surgical procedures have fallen off steeply as the ongoing global pandemic has unfolded, but the real impact on Intuitive Surgical Inc. will come as its hospital customers may have to limit orders for expensive equipment upgrades as they struggle to manage unprecedented financial burdens. The U.S. accounts for about 70% of its robotic surgery procedures, but by the last few weeks in March, that activity had been curtailed by roughly two-thirds.