Industry intelligence for founders building surgical robotics and advanced interventional devices. What I’m reading, what it means, and what it changes for the companies I work with.
May 3, 2026
Stealth AXiS Goes Global as Integrated Platforms Redraw Surgical Robotics Competition
Medtronic announced CE Mark for Stealth AXiS on April 28, five days after the first U.S. surgeons performed cases on the cleared Autopilot system at HCA Virginia’s Reston Hospital Center. Intuitive lifted full-year da Vinci procedure growth guidance on Q1 strength and a da Vinci 5 mix shift, and CMR filed a 510(k) to add gynecology to Versius Plus. Bundled planning, navigation, AI, and robotic delivery is now the unit of competition.
Read more →May 2, 2026
Stryker’s Q1 Cyber Recovery Reframes Resilience as a Medtech Strategic Asset
Stryker reported Q1 2026 on April 30 with a 3-week cyber outage absorbed into the numbers and Mako installations at a record quarter, holding full-year guidance. Medtronic disclosed and contained a separate cyberattack a week earlier with no operational impact. Connected medtech is now in a sustained cyber-pressure environment, and architectural separation of corporate and operational networks has moved into strategic-grade decision territory.
Read more →May 1, 2026
CMR’s Versius Plus Gynecology Filing Anchors a Week of Indication Expansion
CMR Surgical filed a 510(k) on April 29 to add benign gynecology indications to Versius Plus, ten days after the cholecystectomy clearance. enVVeno landed the first-ever FDA IDE for a non-surgical replacement venous valve. The EU Breakthrough Medical Device Pilot opened applications, the EUDAMED mandatory deadline closed in, and Prodeon disclosed Urocross BPH outcomes at AUA 2026.
Read more →April 30, 2026
Adagio’s VT Pivotal Anchors a Week of Specialist Interventional Wins
Adagio Medical reported six-month FULCRUM-VT pivotal data on April 27, hitting 98% acute non-inducibility and 84% freedom from ICD shocks in 209 patients with structural heart disease. Imricor began U.S. commercial sales of NorthStar, the first MR-guided EP mapping system. BrioHealth received conditional FDA approval for a pediatric VAD trial, and Abbott posted dual-energy AFib data at HRS 2026.
Read more →April 28, 2026
CMS and FDA Launch RAPID Pathway as Medicare Coverage Compresses to Months for Breakthrough Devices
CMS and FDA jointly unveiled the RAPID pathway on April 23, allowing a proposed national Medicare coverage decision the same day a breakthrough device receives FDA marketing authorization. Boston Scientific reported pivotal first-line PFA data for Farapulse at HRS 2026, Medtronic’s Sphere-9 received breakthrough designation, and SquareMind closed $18 million for an AI-powered skin-imaging robot.
Read more →April 27, 2026
J&J Wins CE Mark for an Ottava-Compatible Stapler Before the Robot Ships
J&J cleared the Ethicon 4000 surgical stapler in Europe on April 24, designed to run on Ottava in a market where the robot itself does not yet have CE Mark authorization. Edwards raised its 2026 TAVR guidance the same week, contrasting with Boston Scientific’s cut. Conavi Medical and Protaryx Medical each cleared FDA 510(k) milestones in interventional imaging and left-heart access.
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