Robotic Surgery

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

Medtronic chairman and CEO Geoff Martha addressed the promise of artificial intelligence in the company’s medical technologies, AI monetization opportunities, and risk of AI overregulation in a 4 September session at the Wells Fargo Healthcare Conference.

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.

The US Food and Drug Administration released six warning letters and two close-outs last month, including four warnings to marketers of unauthorized continuous positive airway pressure (CPAP) cleaners or sanitizers.

Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.

Caresyntax said it will use the $180m it recently raised in a series C extension and debt financing round to build out its vendor-neutral surgery platform aimed to help surgeons with real-time and long-term decision support to improve patient outcomes and efficiencies.

J&J Medtech announced the FDA clearance of its dual-use robotics platform Velys Spine with plans to go to market in the first half of 2025.

This week, the US FDA sent a warning letter to maker of batteries for AEDs, AMCO; Virtual Incision successfully completed the first hysterectomy its miniaturized robotic-assisted surgery device MIRA; The DOJ finalized a rule that requires government-operated health care facilities to provide accessible equipment for people with disabilities; the FDA compiled its resources on reprocessed medical devices onto a new web page; and more.

CMR Surgical has launched a multicenter pediatric clinical trial for its Versius surgical robot system across three UK sites. The trial will enroll 150 children for urological procedures, with patient outcomes followed for up to a year post-surgery.

This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the government $5m for violating anti-kickback law; eCential Robotics’ spine platform made its debut for human use; and more.

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.

Cutting edge technology could significantly enhance operating room efficiency, according to a new report from Medtronic. The problem, however, is that most ORs don’t have it.

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

This week, the ACLA filed a lawsuit against the US FDA; Philips recalled around 100,000 ventilators; women’s health companies Natural Cycles and Gameto padded their coffers; and Canary Medical and J&J’s Ethicon received FDA nods.

A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.

This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.

Delays have plagued J&J's soft tissue surgical robot. However, the company has now solidified at least its near-term plan and hopes to commence trials later this year.