International News
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Cardiovascular | Surgical
Medtronic's Affera Mapping and Ablation System Gains EU Nod
Includes the Sphere-9 catheter and Affera Prism-1 mapping software.Sam Brusco, Associate Editor 03.15.23
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Cardiovascular | Diagnostics
Philips, Gibraltar Health Authority Ink 16-Year Strategic Deal
Gibraltar Health Authority prepares to provide local coronary angiography and angioplasty services in a new interventional cardiac suite.Sam Brusco, Associate Editor 03.14.23
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TRUMPF, RSP Systems Collaborating on Miniaturized Non-Invasive Glucose Sensor
RSP Systems already has portable, optical, sensor-based devices that can measure glucose levels but they're the size of a paperback book.Michael Barbella, Managing Editor 03.07.23
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Detection Technology Expands Manufacturing in Finland
The company will focus on the end assembly and testing in Oulu of specific product families.Michael Barbella, Managing Editor 03.02.23
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3DPRINTUK Achieves ISO 9001:2015 Certification
Company supplies 3D printed parts for low volume, on-demand batch production.Michael Barbella, Managing Editor 03.01.23
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Cardiovascular
Health Canada Grants License to Quidel's TriageTrue Heart Attack Test
The Quidel TriageTrue hsTnl Test is now available on the smallest footprint analyzer.Michael Barbella, Managing Editor 02.28.23
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TANAKA Contributes to Venture Capital Fund
Fund aims to encourage the development of new products and technologies in the medical field, and contribute to the future of Japan's medical society.Michael Barbella, Managing Editor 02.28.23
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AI-Enhanced Medical Devices to Boost South Korean Ophthalmic Market
Sector forecast to reach $156 million in 2030.Michael Barbella, Managing Editor 02.27.23
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Diagnostics
Hyperfine's Swoop Portable MRI Receives CE Mark
The clearance was granted under the new EU Medical Device Regulation (MDR).Sam Brusco, Associate Editor 02.21.23
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SIMPLEX QUANTUM Inc. Raises ¥550 Million in Series A Funding
Money will help support the company's clinical trial for heart failure detection AI technology.Michael Barbella, Managing Editor 02.21.23
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Innovative Diagnostics to Provide Better Care for Neurological Disorders in Japan
The country holds a strong position in the diagnostic imaging market, with approximately 26.9% share in the Asia-Pacific region.Michael Barbella, Managing Editor 02.21.23
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Cardiovascular | Digital Health
Methinks Gains EU Nod for AI Stroke Triage Software
Can provide early, automated detection of large vessel occlusions, hyperdense and not, from non-contrast computed tomographies.Sam Brusco, Associate Editor 02.21.23
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Cardiovascular
Medtronic's Extravascular Defibrillator System Gains EU Nod
Aurora EV-ICD's lead is placed outside the heart and veins, which can avoid risks found in transvenous devices.Sam Brusco, Associate Editor 02.17.23
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Japanese Regulators Approve Pulmonx's Zephyr Endobronchial Valve
Approval is based on a review by the PMDA of the positive clinical data from the pivotal LIBERATE study.Michael Barbella, Managing Editor 02.15.23
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Positive Long-Term Prospects for Japanese Diabetes Care Market
Japan is one of the high-potential markets for the development of diabetes care devices.Michael Barbella, Managing Editor 02.06.23
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Sissel Lønning Andresen Named LINK Medical CEO
New leader was most recently the CEO of Pfizer Norway.Michael Barbella, Managing Editor 02.02.23
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Japanese Universities Start Joint Trials for Fall Detection Tech
The two parties are working to offer a millimeter-wave sensor service for privacy-conscious monitoring to hospitals and nursing facilities in fiscal 2023.Michael Barbella, Managing Editor 02.01.23
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Soundbite Medical Forges China Commercialization Pact With VFLO Medical
VFLO will manufacture, develop, and commercialize certain proprietary products in the greater China region.Michael Barbella, Managing Editor 01.26.23
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Surgical
Asensus Surgical Earns CE Mark for Further Machine Vision Capabilities
Expands machine vision capabilities on its previously cleared Intelligent Surgical Unit (ISU).Sam Brusco, Associate Editor 01.23.23
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Japanese Regulators Approve Motiva Implants, Tissue Expander
The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System.Michael Barbella, Managing Editor 01.20.23
