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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

News

Hypertension
Medtronic Announces CMS National Coverage Analysis for Symplicity™ Spyral Renal Denervation System
01/14/2025
The Symplicity Spyral RDN system, approved by the U.S. FDA in November 2023, is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood...
The Symplicity Spyral RDN system, approved by the U.S. FDA in November 2023, is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood...
The Symplicity Spyral RDN...
01/14/2025
Cath Lab Digest
Pulmonary Embolism
AngioDynamics Announces Publication of APEX-AV Trial Results in JSCAI
01/13/2025
Peer-reviewed data highlights successful clinical study with 35.5% clot burden reduction, validating the safety, efficacy, and efficiency of AlphaVac F1885 System in pulmonary embolism treatment. LATHAM, N.Y.--(BUSINESS WIRE)--Jan. 13,...
Peer-reviewed data highlights successful clinical study with 35.5% clot burden reduction, validating the safety, efficacy, and efficiency of AlphaVac F1885 System in pulmonary embolism treatment. LATHAM, N.Y.--(BUSINESS WIRE)--Jan. 13,...
Peer-reviewed data highlights...
01/13/2025
Vascular Disease Management
Thrombectomy
Inquis Medical Completes Enrollment in U.S. Pivotal IDE Trial of the Aventus Thrombectomy System Designed to Treat Patients With Pulmonary Embolism
01/13/2025
MENLO PARK, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Inquis Medical, a leading innovator in venous thromboembolic disease treatment, today announced completion of patient enrollment in its AVENTUS Clinical Trial, a pivotal Investigational...
MENLO PARK, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Inquis Medical, a leading innovator in venous thromboembolic disease treatment, today announced completion of patient enrollment in its AVENTUS Clinical Trial, a pivotal Investigational...
MENLO PARK, Calif., Jan. 13,...
01/13/2025
Vascular Disease Management
Bioresorbable Scaffolds
R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDE Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
01/13/2025
Eric A. Secemsky, MD, MSc, lead investigator for the ELITE-BTK pivotal trial, said, “R3 Vascular’s novel approach in the design of its next generation bioresorbable drug eluting scaffold is of great interest to the physician community and has...
Eric A. Secemsky, MD, MSc, lead investigator for the ELITE-BTK pivotal trial, said, “R3 Vascular’s novel approach in the design of its next generation bioresorbable drug eluting scaffold is of great interest to the physician community and has...
Eric A. Secemsky, MD, MSc, lead...
01/13/2025
Vascular Disease Management
News
20th Anniversary Leipzig Interventional Course (LINC) to Feature 40+ Live Cases, First-to-podium Data Releases
01/13/2025
Clinicians from Germany, Dubai, Japan, U.S., Switzerland among scrub-in and live case transmissions; educational program features 500+ vascular, endovascular presentations. MALVERN PA., (January 13, 2024) — First-to-podium data...
Clinicians from Germany, Dubai, Japan, U.S., Switzerland among scrub-in and live case transmissions; educational program features 500+ vascular, endovascular presentations. MALVERN PA., (January 13, 2024) — First-to-podium data...
Clinicians from Germany,...
01/13/2025
Vascular Disease Management
Ischemic Stroke
Medtronic Expands U.S. Carotid Market Presence With Exclusive Contego Medical Distribution Agreement
01/13/2025
This agreement includes Contego Medical’s portfolio of commercially available products, including the recently FDA approved Neuroguard IEP® System, a unique 3-in-1 carotid stenting system that combines a high-performance stent, post-dilation...
This agreement includes Contego Medical’s portfolio of commercially available products, including the recently FDA approved Neuroguard IEP® System, a unique 3-in-1 carotid stenting system that combines a high-performance stent, post-dilation...
This agreement includes Contego...
01/13/2025
Cath Lab Digest
Clot-Sensing Guidewire
Sensome Announces Data From Two New Studies Showing Clot-Sensing Guidewire Successfully Identifies Fresh Clot to Support Decision-Making in Peripheral Artery Disease Treatment
12/13/2024
Data showcased in two late-breaking clinical trial presentations at Paris Vascular Insights Course PARIS – December 13, 2024 – Sensome, the pioneer of microsensing technology for instant intra-operative tissue analysis, today announced...
Data showcased in two late-breaking clinical trial presentations at Paris Vascular Insights Course PARIS – December 13, 2024 – Sensome, the pioneer of microsensing technology for instant intra-operative tissue analysis, today announced...
Data showcased in two...
12/13/2024
Vascular Disease Management
News
Echo IQ Signs Integration Agreement With Flagship US Hospital
12/12/2024
The integration follows the completion of a successful trial of EchoSolv-AS at Beth Israel in September 2024, in which BIDMC researchers validated the technology’s key performance metrics.
The integration follows the completion of a successful trial of EchoSolv-AS at Beth Israel in September 2024, in which BIDMC researchers validated the technology’s key performance metrics.
The integration follows the...
12/12/2024
Vascular Disease Management
Terumo R2P Navicross
Radial to Peripheral
Terumo Interventional Systems Announces Launch of Its R2P NaviCross Peripheral Support Catheter
12/03/2024
“With the 200 cm length, the R2P NaviCross catheter provides physicians performing percutaneous transluminal endovascular procedures from the radial artery a valuable tool to enhance their ability to safely and efficiently complete more...
“With the 200 cm length, the R2P NaviCross catheter provides physicians performing percutaneous transluminal endovascular procedures from the radial artery a valuable tool to enhance their ability to safely and efficiently complete more...
“With the 200 cm length, the R2P...
12/03/2024
Cath Lab Digest
Bridging Stent for FEVAR
World premiere for Bentley’s BeFlared Bridging Stent: Successful “First in Man” Operation
12/02/2024
Hechingen, November 26th, 2024 -- Shortly after receiving the CE certification for its BeFlared Stent Graft System, the world’s first dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR), Bentley announced the...
Hechingen, November 26th, 2024 -- Shortly after receiving the CE certification for its BeFlared Stent Graft System, the world’s first dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR), Bentley announced the...
Hechingen, November 26th, 2024...
12/02/2024
Vascular Disease Management

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