Distalmotion targets ASC gynecology programs with new FDA filing
Distalmotion has submitted a 510(k) application to the FDA seeking to expand the label of its Dexter robotic surgery system into additional gynecological indications, the company announced April 1.
The filing covers sacrocolpopexy, sacrocervicopexy and endometriosis resection. Sacrocolpopexy and sacrocervicopexy are procedures used to treat pelvic organ prolapse; endometriosis resection removes tissue growing outside the uterus. The FDA has already cleared Dexter for use in gallbladder, hysterectomy and hernia repair procedures.
Distalmotion has specifically identified ambulatory surgery centers (ASCs) – which often have less space, resources and infrastructure than hospitals – as settings where Dexter could hold a competitive advantage over larger surgical robots. The Swiss company raised $150 million in November to accelerate commercial adoption of the platform.
“Expanding gynecology capabilities in outpatient environments represents an important next step in the evolution of the Dexter robotic program,” CEO Greg Roche said in a statement.
Distalmotion is not alone in targeting the ASC robotic gynecology market.
Intuitive Surgical CEO David Rosa cited benign gynecological surgeries as procedures well-suited to the ASC environment on a January earnings call, and Vicarious Surgical has also identified gynecological procedures as a focus for its ASC-oriented robot.
Stryker acquires Amplitude Vascular Systems to expand peripheral vascular portfolio
Stryker (NYSE: SYK) announced April 13 that it has signed a definitive agreement to acquire Amplitude Vascular Systems (AVS), a Boston-based medical device company developing a next-generation intravascular lithotripsy (IVL) platform for treating calcified peripheral arterial disease.
AVS’ technology uses pulsed CO2-generated pressure waves delivered through an IVL balloon catheter to fracture calcium and optimize luminal gain. The platform is designed to improve catheter deliverability, treatment speed and therapy efficiency.
The acquisition is intended to strengthen Stryker’s Peripheral Vascular portfolio by adding revascularization technology. IVL is described in the release as a fast-growing technology in cardiovascular intervention, with strong adoption expected as physicians increasingly use IVL-based calcium modification in complex procedures.
The transaction is subject to customary closing conditions; financial terms were not disclosed.
Medtronic to acquire CathWorks in deal valued at up to $585 million
Medtronic (NYSE: MDT) announced Feb. 3 that it will exercise its option to acquire CathWorks, a privately held medical device company focused on transforming how coronary artery disease is diagnosed and treated.
The deal is valued at up to $585 million, with potential additional earn-out payments post-acquisition, according to a Medtronic press release.
The acquisition follows a 2022 strategic partnership and co-promotion agreement for CathWorks’ FFRangio System, which uses artificial intelligence and computational science to deliver fractional flow reserve (FFR) values from routine coronary angiograms – eliminating the need for invasive pressure wires and drug stimulation.
“This acquisition allows Medtronic to transform the cath lab with a technology that provides real-time data, informs individualized treatment approaches, and drives new standards of care,” Jason Weidman, senior vice president and president of Medtronic’s Coronary & Renal Denervation business, said in an announcement.
The deal is pending FTC clearance and is expected to close by the end of Medtronic’s fiscal year 2026.
Hopper OS acquires Efferent
Phoenix-based Hopper OS announced March 24 the acquisition of Efferent, a health care informatics company specializing in cloud-based picture archiving and communication systems (PACS), interoperability and enterprise imaging infrastructure.
The deal is intended to allow Hopper OS – which markets itself as a configurable intelligent operating system for ASCs, health systems and physician practices – to add imaging alongside its existing suite of EMR, patient management, agentic AI, analytics and IT services.
Stratus Medical closes $10 million Series B to advance RF ablation technology
Magnolia, Texas-based Stratus Medical announced Feb. 4 the close of a $10 million Series B financing round led by Wasatch Health Partners.
The company, which focuses on radiofrequency ablation treatment for chronic pain, said proceeds will be used to complete development of its RF Generator and neurovasis basivertebral nerve ablation (BVNA) technology – targeting vertebrogenic low back pain, a condition estimated to affect more than 5 million Americans.
Funds will also support a clinical study and expansion of the company’s patent portfolio.
“Stratus Medical is proud to work with outstanding physicians, hospitals, and ASCs, and we are anxious to deliver additional value with our future RF technologies that this financing enables us to complete,” CEO Bret Boudousquie said.
The neurovasis BVNA technology has not yet been submitted to or cleared by the FDA.
