Sim&Cure Announces U.S. FDA 510(k) Clearance for Sim&Size software

September 27, 2019

Montpellier – Sim&Cure is honored and proud to announce last September 17, Sim&Size® obtained U.S.Food and Drug Administration (FDA) 510(k) clearance.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement and deployment of neuro-interventional devices.

Sim&Size® and its numerous advantages

According to the patient’s unique anatomy, Sim&Size® computationally modelizes neurointerventional devices to provide essential information for preoperational planning. Directly integrated into the medical workflow, Sim&Size® seeks to dramatically simplify the process and to benefit to:

  • Patient: faster surgery, less X RAY exposure
  • Hospital: smaller surgery cost, faster surgery
  • Neuro-Interventionalists: improve and facilitate the therapeutic preoperational planning, faster surgery, less X RAY exposure.

"Planning the strategy of the surgery with this level of accuracy is a promising procedure with a growing frame of clinical evidence", said Prof. Vincent Costalat, Head of Department Neuroradiology - CHU Montpellier, "Sim&Size software helps physicians in a clinical routine to treat intracranial aneurysms more efficiently, considering patient specific anatomy to select the best implant for a given patient-specific anatomy"

"There is a growing trend of physicians interested in improving their therapeutic planning and looking for value-based outcomes" said Mathieu Sanchez, Ph.D., chief executive officer at Sim&Cure. "Sim&Cure is pleased to continue to lead the industry with product innovations and training to support this emerging therapy technique"

In collaboration with leading physicians, researchers and engineers worldwide, Sim&Cure offers the broadest range of innovative medical technology for the neuro-interventional treatment of intracranial aneurysms. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Sim&Cure

Founded in 2014 and located in the vibrant MedTech ecosystem in Montpellier, France, Sim&Cure is a digital startup focused on improving endovascular surgery. The first focus of the company is the treatment of cerebral aneurysm with a proprietary software suite Sim&Size (Class IIa medical device with CE mark) that has already been used to treat more than 2,500 patients in 250 hospitals since January 2018.

The company employs 20 people and anticipates a phase of strong growth with 10 additional recruitments in 2019 with in particular, the opening of a subsidiary in the US. Learn more



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Source: Sim&Cure


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