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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

Expanded indication

Okami Medical adds peripheral venous embolization to the LOBO indication

MedDevice Startups Staff · Oct 8 · 2 min read · Via Endovascular Today

FDA expanded the indication for Okami Medical's LOBO vascular occlusion system to cover peripheral venous embolization. Okami announced the change on October 8 and named pelvic venous disease and portal hypertension as the conditions it reaches.

LOBO uses the company's HDBraid construction, a dense braid Okami says holds position while it occludes. Raj Pyne of Rochester Regional Health said the device places precisely and leaves less CT streak artifact, which matters in venous work where patients come back for surveillance imaging. An indication expansion on an existing construction is the cheapest regulatory move in the business, and this one moves LOBO into a second interventional service line with no new build.

Questions & Answers

What did Okami Medical's expanded LOBO indication cover?

FDA expanded the indication for Okami Medical's LOBO vascular occlusion system to include peripheral venous embolization, announced October 8, 2026. Okami cites pelvic venous disease and portal hypertension as target conditions.

What is the Okami Medical LOBO occluder?

LOBO is Okami Medical's vascular occlusion system, built on the company's HDBraid dense braid construction for deliverability and stable placement. As of October 2026 its indication includes peripheral venous embolization.

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