CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system. The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022. […]
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CereVasc, LianMedical announce corporate partnership
CereVasc today announced a partnership with LianMedical to bring CereVasc’s technology to Asia. The partnership aims to accelerate the introduction of breakthrough medical technologies to markets in China, Hong Kong, Taiwan and Macaw. The partnership will focus on bringing CereVasc’s eShunt system and related products to the region. “We are very excited by the opportunity […]
Cerevasc has a new chief medical officer
CereVasc announced today that it appointed Dr. Adel Malek as its new chief medical officer (CMO). The Boston-based neurological disease treatment company develops the eShunt system for treating communicating hydrocephalus. In a news release, it said Malek’s appointment can help further accelerate the development and clinical strategy for eShunt. Current treatment for hydrocephalus requires an […]
CereVasc completes first eShunt procedure in U.S.
CereVasc announced today that it completed the first procedure with its eShunt device in the U.S. as part of a pilot study. Boston-based CereVasc’s first eShunt procedure was completed as part of a U.S. pilot study of the system in normal pressure hydrocephalus (NPH) being conducted under FDA investigational device exemption (IDE). Approval for the […]
FDA approves second IDE study for CereVasc eShunt
CereVasc announced today that it received a second FDA investigational device exemption (IDE) for its eShunt system. The IDE allows CereVasc to initiate a pilot trial of the eShunt system in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). The company received its first IDE to begin a trial of the eShunt for […]
CereVasc wins FDA IDE approval to begin eShunt pilot study
CereVasc today announced that it received an FDA investigational device exemption approval to begin a trial of the eShunt for normal pressure hydrocephalus. The Boston-based company can initiate its pilot trial of the eShunt system in patients with normal pressure hydrocephalus (NPH). The eShunt device offers a minimally invasive treatment with the potential to result in […]
CereVasc successfully performs first-in-human procedure with eShunt system
CereVasc announced today that it completed the first treatment with its eShunt system for treating communicating hydrocephalus (CH). Boston-based CereVasc touts the eShunt as the first minimally invasive cerebrospinal fluid shunt and delivery technology designed to avoid the need for invasive surgery and extended hospitalization associated with the current surgical treatment of hydrocephalus. The company […]
CereVasc closes $43.9m Series A
Hydrocephalus treatment developer CereVasc announced today that it closed an expanded Series A financing round, raising a total of $43.9 million. The Perceptive Xontogeny Venture (PXV) Fund and ATON Partners led the funding round, according to a news release. CereVasc intends to use the raised proceeds to support the first-in-human clinical trial for its eShunt […]
Sunrise Labs executes succession plan | Personnel Moves – April 5, 2018
Medical device and life science development group Sunrise Labs said this week that it completed its succession plan, with president Eric Soederberg acquiring the majority of shares in the company through a stock sale with founder and board chair Drew Sunstein. With the transaction, the Bedford, N.H.-based company said that it secured its planned ownership […]
