SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The IMPEDE Embolization Plug family, previously […]
Peripheral/Endo
Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma
– TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery. – Approval builds on a trusted solution in neurovascular embolization for over 25 years. IRVINE,…
Profusa U.S. Study Met Primary End Points as Presented at Late Breaking Clinical Trials at Paris Vascular Insights 2025
Data from FDA-advised study demonstrates Lumee™ Oxygen tissue monitoring is a safe and effective long-term method in PAD patients and will support potential FDA submission; strongly correlates with transcutaneous partial pressure of oxygen
MMI Wins FDA Clearance and Completes First U.S. Clinical Use of Robotic Microsurgical Dissection Instruments with Symani
First U.S. Patient Treated with NanoWrist Dissection Instruments, Marking Early Clinical Adoption and Portfolio Growth JACKSONVILLE, FL —December 9, 2025 — MMI (Medical Microinstruments, Inc.), a robotics company dedicated to expanding treatment options and improving outcomes for patients with complex conditions, today announced that it received U.S. Food and […]
Brainomix Announces New Study Published in Lancet Digital Health Demonstrating Impact of Brainomix 360 Stroke to Increase Endovascular Thrombectomy Rates
Study in Lancet Digital Health represents the largest real-world evaluation of stroke AI imaging, encompassing data from more than 450,000 patients admitted to 107 NHS England hospitals over a 5-year period Brainomix 360 Stroke was deployed to 26 hospitals to evaluate the impact on stroke…
Carta Healthcare Partners with Fivos to Elevate Data Quality and Advance Vascular Patient Care
SAN FRANCISCO, Dec. 2, 2025 /PRNewswire/ — Carta Healthcare, a leading provider of AI-powered clinical data abstraction solutions, today announced a strategic partnership with Fivos, a leading provider of data solutions for medical research organizations and device manufacturers, as well…
MMI Announces CPT Code and CMS Reimbursement for Robotic Lymphatic Surgery, Unlocking Market Access and Growth Potential
MMI, today announced that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT®) code for lymphovenous bypass.
MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease
MannKind Announces U.S. FDA Accepts for Review its sNDA of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in adults with CHF or CKD
Microbot Medical® Announces Emory University Hospital as the First Hospital in the World to Adopt the New LIBERTY® Endovascular Robotic System
Microbot Medical® Announces Emory University Hospital as the First Hospital in the World to Adopt the New LIBERTY® Endovascular Robotic System
RapidAI Extends the Reach of Deep Clinical AI with Five New FDA Clearances
New clearances expand the Rapid Enterprise Platform, advancing radiology precision, and elevating neurology and vascular care through deep clinical AI SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the pioneer of deep clinical AI and global leader in enterprise imaging, today announced the U.S. Food and Drug Administration (FDA) clearance of five new imaging […]



