artery including News
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BioMimics 3D Vascular Stent System granted Shonin in Japan – December 2019
The BioMimics 3D Vascular Stent System received Shonin regulatory approval in Japan. On December 19th, 2019, Japanese MHLW PMDA granted Marketing Pre-Market Approval (“Shonin”) for BioMimics 3D Vascular Stent System to improve luminal diameter during endovascular intervention in patients with symptomatic peripheral arterial disease in the femoropopliteal artery. The approved ...
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CathWorks FFRangio System Receives Regulatory Approval in Japan
CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, ...
By CathWorks
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Amsel Medical Announces Appointment of Jeff Willis as Senior Director of Engineering
Amsel Medical Corp. today announced the appointment of Jeff Willis as Senior Director of Engineering to help drive the current product commercialization phase and implement the company’s strategy to address the demand for minimally invasive, simple and secure occlusion. “Jeff is an exceptionally focused engineer and executor,” said Amsel Medical CEO David Doster. “He ...
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Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders To Address A Wide Range Of Peripheral Embolization Cases
Aliso Viejo, CA – June 7, 2022 – Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO® Vascular Occlusion ...
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Amsel Medical Announces Expanded Medical Advisor Group
Amsel Medical Corp. today announced the expansion of its medical advisory team as the company advances the current product commercialization phase to address the demand for minimally invasive, simple and secure occlusion. Joining the advisory team are - Col. John Dorsch, DO, USAF, Retired; prior wing surgeon, physician, and medical officer for the 24th Special Operations Wing (Air Force ...
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Amsel Medical Announces Director of Clinical and Medical Affairs
Amsel Medical Corp. today announced the appointment of Lowell S. Kabnick as a consultant acting as Director of Clinical and Medical Affairs, as the company advances the current product commercialization phase to address the demand for minimally invasive, simple and secure occlusion. In addition to serving as the Chancellor of the Vein & Lymphatic University, Dr. Kabnick is the previous ...
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QXMedical Licenses Bioresorbable Embolic Technology from U of MN
QXMédical acquired the world-wide exclusive rights to the bioresorbable embolic technology developed by researchers and physicians at the University of Minnesota to fill a clinical need for resorbable and drug-loadable microspheres and hydrogels. Embolics are used by interventional radiologists and oncologists to occlude vessels for a variety of clinical indications. Current market leaders ...
By QXMedical
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Amsel Medical Announces Appointment of Robert M. Rossell as Chief Commercial Officer
Amsel Medical Corp. today announced the appointment of Robert M. Rossell as Chief Commercial Officer to drive the current commercial phase and implement the company’s strategy to address the demand for minimally invasive, simple and secure occlusion. “I’ve worked with Rob over many years. He brings a great depth of experience, commercial expertise and a track record of ...
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Shockwave Medical Announces Global Launch of New Peripheral Intravascular Lithotripsy Catheter
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the global commercial availability of the Shockwave M5+ peripheral IVL catheter after receiving both CE Mark and U.S. Food and Drug Administration (FDA) clearance. The Shockwave M5+ catheter, which has been in limited launch ...
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Focal Healthcare and CIMTEC Sign Licensing Agreement for a Suite of 3D Ultrasound AI-Based Technologies
The collaboration allows Focal Healthcare to develop a smart 3D ultrasound imaging platform for point of care use. TORONTO, CANADA – Focal Healthcare, known globally as a leading innovator of image-guided prostate cancer technology, is diversifying their product line by developing an AI-based 3D ultrasound imaging platform. Focal Healthcare has licensed patents from the Centre for Imaging ...
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Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation
The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. The approval is based on data from the Phase III VOYAGER PAD trial. This study demonstrated a positive ...
By Bayer AG
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Next Science and 3M Donate $300,000 of Breakthrough Wound Treatment to Jacksonville-Area Charities
Next Science (ASX:NXS), an innovative medical technology company that is the leader in treating biofilm-based infections in humans, announced today that it has donated $300,000 worth of BlastX™ Antimicrobial Wound Gel to The Save A Leg, Save A Life Foundation in Ponte Vedra. The donation will support the foundation’s mission of reducing lower extremity amputations and improving wound ...
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FDA Approves BAVENCIO (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma
BAVENCIO is the first anti-PD-L1 in combination with axitinib approved by FDA for first-line treatment of patients with advanced renal cell carcinoma (RCC) Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib Combination approved based on ...
By Siemens AG
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