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Navigating Regulations When Starting an OBL

03/03/2018

Mark Garcia, MD, explains the nuances of regulations and the importance of contacting a lawyer who can assist in navigating the process.


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Vascular Disease Management Newsletter

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News

thrombectomy
Surmodics Receives FDA 510(k) Clearance for Pounce™ XL Thrombectomy System, Expanding the Pounce Thrombectomy Platform to Larger Peripheral Arteries up to 10 mm in Diameter
10/02/2024
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter, making it suitable for iliac, femoral, and other arteries within...
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter, making it suitable for iliac, femoral, and other arteries within...
The Pounce XL Thrombectomy...
10/02/2024
Vascular Disease Management
News
Microbot Medical Announces the Successful Enrollment of 50% of the Patients in its Pivotal Human Clinical Trial for the LIBERTY® Endovascular Robotic Surgical System
09/20/2024
BRAINTREE, Mass., September 17, 2024 -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal...
BRAINTREE, Mass., September 17, 2024 -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal...
BRAINTREE, Mass., September 17,...
09/20/2024
Vascular Disease Management
Pulmonary Embolism
SPIRARE I Trial: Jupiter Endovascular Announces First Patients Successfully Treated in First Clinical Study of Vertex Pulmonary Embolectomy System Using Endoportal Control
09/19/2024
“In these first cases, the Vertex system was successful in safely navigating through the right heart and into the pulmonary vasculature, facilitating an efficient and effective pulmonary embolectomy with no safety issues,” said Professor...
“In these first cases, the Vertex system was successful in safely navigating through the right heart and into the pulmonary vasculature, facilitating an efficient and effective pulmonary embolectomy with no safety issues,” said Professor...
“In these first cases, the...
09/19/2024
Cath Lab Digest
Carotid Stenting
InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard Prime Carotid Stent System
09/18/2024
The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May.
The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May.
The PMA application is based on...
09/18/2024
Cath Lab Digest
Carotid Artery Revascularization
Boston Scientific Closes Acquisition of Silk Road Medical, Inc.
09/17/2024
Silk Road Medical, Inc., is a medical device company that pioneered a new approach for stroke prevention and the treatment of carotid artery disease through a minimally invasive procedure called transcarotid artery revascularization (TCAR).
Silk Road Medical, Inc., is a medical device company that pioneered a new approach for stroke prevention and the treatment of carotid artery disease through a minimally invasive procedure called transcarotid artery revascularization (TCAR).
Silk Road Medical, Inc., is a...
09/17/2024
Cath Lab Digest
Professional Training
Calling Clinicians: Dartmouth Health Announces Launch of Medical Device Innovations Training Program
09/17/2024
"The medical device ecosystem needs active clinicians to guide the development process at companies and regulatory agencies," says Aaron V. Kaplan, MD, FACC, FNAI. “This program will provide scholars with a deep understanding of the medical...
"The medical device ecosystem needs active clinicians to guide the development process at companies and regulatory agencies," says Aaron V. Kaplan, MD, FACC, FNAI. “This program will provide scholars with a deep understanding of the medical...
"The medical device ecosystem...
09/17/2024
Cath Lab Digest
Philips LumiGuide Navigation Wire
Intravascular Imaging
Philips Announces FDA Approval for Enhanced LumiGuide Guidewire and Marks 1000th Patient Treated With Its Breakthrough 3D Device Guidance Technology
09/17/2024
“LumiGuide unlocks the color visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically...
“LumiGuide unlocks the color visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically...
“LumiGuide unlocks the color...
09/17/2024
Cath Lab Digest
Shockwave E8 Peripheral IVL Catheter
Intravascular Lithotripsy
Shockwave Medical Expands U.S. Peripheral IVL Portfolio with Enhanced Catheter
09/16/2024
The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).  
The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).  
The Shockwave E8 catheter is...
09/16/2024
Cath Lab Digest
News
Argon Medical Launches CLEANER Vac™ Thrombectomy System to Remove Blood Clot in the Peripheral Venous Vasculature
09/16/2024
PLANO, Texas, Sept. 16, 2024 /PRNewswire/ -- Argon Medical Devices, a leading provider of medical device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announced the launch of the...
PLANO, Texas, Sept. 16, 2024 /PRNewswire/ -- Argon Medical Devices, a leading provider of medical device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announced the launch of the...
PLANO, Texas, Sept. 16, 2024...
09/16/2024
Vascular Disease Management
Aneurysms
Study: Why Aortic Aneurysms Form at the Arch or in the Abdominal Segment
08/20/2024
In order to find out what distinguishes the repeatedly affected vascular regions from others, Daniela Wenzel and her team developed a method to specifically examine the endothelium of the aorta. “We know from other vascular diseases such as...
In order to find out what distinguishes the repeatedly affected vascular regions from others, Daniela Wenzel and her team developed a method to specifically examine the endothelium of the aorta. “We know from other vascular diseases such as...
In order to find out what...
08/20/2024
Cath Lab Digest

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