February 16, 2023—The American College of Cardiology (ACC), American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) announced they have jointly issued a clinical document outlining competency-based tr…
Category: endovascular
Perfuze’s Millipede 088 Access Catheter for Acute Ischemic Stroke Receives FDA Clearance
February 16, 2023—Perfuze, an Ireland-based medical device company, announced that its Millipede 088 access catheter was granted United States FDA 510(k) clearance for use in treating acute ischemic stroke.
According to the company, the Millip…
EndoStream Medical Begins Enrollment in United States TORNADO-US Trial for Nautilus Intrasaccular System
February 15, 2023—EndoStream Medical, a company developing solutions for brain aneurysms, announced that the first patient was enrolled in the TORNADO-US clinical study in the United States. The study will evaluate the company’s Nautilus in…
Cydar Medical Names Kenneth Hitchner as Chairman
February 14, 2023—Cydar Medical, a global cloud-based software company, announced the appointment of Kenneth Hitchner as Chairman of the Board with immediate effect. Stepping down from the Board are Lord Mervyn Davies of Abersoch (Chairman since …
Biotronik’s Oscar Multifunctional Peripheral Catheter Gains FDA Clearance and CE Mark
February 14, 2023—Biotronik announced it has received FDA 510(k) clearance and CE Mark for its latest device, the Oscar multifunctional peripheral catheter.
According to the company, Oscar is intended for percutaneous transluminal intervention…
Concept Medical’s MagicTouch PTA SCB Receives IDE Approval to Study Treatment of BTK Arterial Disease
February 13, 2023—Concept Medical Inc. announced that its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) has received FDA investigational device exemption (IDE) approval for the treatment of below-the-knee (…
Cydar Medical Raises Funding to Advance AI Surgical Maps Software
February 13, 2023—Cydar Medical, a cloud-based surgical software company, announced it has completed a Series A funding round and plans to use proceeds to scale-up the commercial rollout of its Cydar EV Maps artificial intelligence (AI) surgical …
BEST II Evaluates Safety of Lowering Blood Pressure After Mechanical Thrombectomy
February 10, 2023—The American Stroke Association (ASA) announced findings from a clinical trial that suggest using medications to lower systolic blood pressure may not be safe or effective among patients who have an acute ischemic stroke and und…
SCAI Comments on CMS National Coverage Determination for Carotid Artery Stenting
February 10, 2023—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that it submitted comments on February 8 to the Centers for Medicare & Medicaid’s (CMS) national coverage analysis for percutaneous transl…
Nanoflex Robotics Secures Funding for Endovascular Navigation Platform
February 9, 2023—Nanoflex Robotics AG, a Switzerland-based developer of magnetically controlled medical soft robotics, announced that it has achieved an initial $12 million in funding. The company’s technology is being developed to generate…