Search Results for 'mhlw'
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R&D & Design
Four Considerations for Developers of Next-Generation Combination Products
Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20
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Cardiovascular
Japanese Regulators Approve Non-Invasive Angiography Technology
The CathWorks FFRangio System transforms angiogram images into color-coded 3D renderings of blood flow in coronary arteries.PR Newswire 01.31.20
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Abiomed's Impella Crosses 1,000-Patient Treatment Threshold in Japan
The first patient in Japan was successfully treated in October 2017.Business Wire 11.15.19
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Cardiovascular
Medtronic Launches Valiant Navion Thoracic Stent Graft System in Japan
Lower-profile thoracic endovascular aortic repair device continues to broaden global treatable patient population with thoracic aortic disease.Globe Newswire 10.31.19
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Broad Reimbursement Approval Given in Japan for TransEnterix's Senhance Digital Laparoscopy System
Reimbursement decision provides expanded access to Senhance Digital Laparoscopy for patients, surgeons, and hospitals across Japan.Business Wire 09.26.19
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Profound Medical Sells First TULSA-PRO System in Japan
Japan has the highest number of MRI units per person of all OECD countries.Globe Newswire 08.29.19
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TransEnterix Announces Japanese Regulatory Approval of the Senhance Surgical System
Regulators approved the product for use in laparoscopy for general surgery, gynecology, urology and certain thoracic procedures.Business Wire 07.17.19
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Cardiovascular
Cardiovascular Systems Receives Japanese Approval for Diamondback 360 Coronary System
Regulators okay system with Classic Crown and new ViperWire Advance FlexTip Guidewire.Business Wire 02.12.19
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Cardiovascular | Surgical
Abbott's MitraClip Therapy Now Reimbursed in Japan for Mitral Regurgitation
National reimbursement adds the device into Japan's health insurance system, which enables greater access for patients.Abbott Laboratories 03.19.18
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Act Now to Prepare for MDSAP Audits
...Kim Trautman, Executive Vice President of Medical Device International Services, NSF International 01.29.18
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MDSAP: Its Value to Your Business and How to Adhere
Benefits gained from compliance with this program outweigh the additional challenges encountered at the onset.Online Exclusives Peter Rose, Managing Director Europe, Maetrics 09.12.17
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Abbott’s FreeStyle Libre Now Reimbursed Across Japan
Nationally reimbursed for all people with diabetes on insulin therapy—more than 1 million people, both type 1 and type 2.PR Newswire 08.31.17
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SpaceOAR System Receives Shonin Approval in Japan
Advanced hydrogel technology used during prostate cancer radiation therapy now available in Japan.Business Wire 06.14.17
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Cardiovascular
Cardiovascular Systems Receives U.S., Japanese Approvals for Diamondback 360 Coronary Micro Crown
Product is designed to both pilot tight lesions and treat up to 4 mm vessels with a single device.Business Wire 04.11.17
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Diagnostics
Accuray Radixact System Receives Japanese Shonin Approval
Radixact platform is now available in Japan, certain European markets, and the United States.Accuray Inc. 02.15.17
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Cardiovascular
Abbott's Absorb Bioresorbable Stent Approved as First Fully Dissolving Heart Stent in Japan
Japan becomes the latest country to approve Absorb, following recent approvals in the United States and Canada.PR Newswire 11.07.16
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Glaukos iStent Trabecular Micro-Bypass Stent Approved in Japan
Approved by the MHLW for use in combination with cataract surgery.Glaukos Corporation 03.30.16
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Materials | R&D & Design
