Intuitive Surgical Inc. strengthened its position as the market leader in robotic-assisted surgery in 2025 on the back of increasing demand for minimally invasive procedures. Intuitive’s da Vinci system is seeing robust growth in procedures and installations, fueling increased revenues.
Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation.
Sometimes the darkest products (names) bring a bright spot of news to their developers, as the U.S. FDA clearance for Galway, Ireland-based Medtronic plc's Onyx liquid embolic system demonstrates. Onyx gained the indication for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma based on the EMBOLISE trial results. The approval represents a significant advancement in treating this common neurosurgical condition.
The first international consensus framework for the use of continuous ketone monitoring in people with diabetes, published in The Lancet Diabetes & Endocrinology, calls development and use of ketone sensors for the prevention of diabetic ketoacidosis “transformational.” Several companies in the diabetes technology market have recently reported that they are developing dual glucose-ketone sensors, though none have gained U.S. FDA approval yet.
The U.S. FDA’s clearance of Medtronic plc’s Hugo robotic-assisted surgery (RAS) system is certainly a boon for the company which is betting on the unit to be a key growth driver. While the soft tissue robotics market is dominated by Intuitive Surgical Inc.’s da Vinci system, the space is growing, and Medtronic has the scale, resources and market presence to make headway but there are also a plethora of smaller, versatile and cost-effective systems looking for a piece of the pie.
Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.
Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral neuromodulation therapy with Medtronic’s Interstim system.
The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.
Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.
Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.
