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Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke. “Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news

HeartFlow wins Japanese reimbursement for FFRct analysis
HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis. The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1. “When a patient presents with symptoms suggesting CAD, we want to be able to quickly and effectively diagnose patients while reducing the need for unnecessary tests or invasive procedures. In clinical studies, we were able to see firstha...
Source: Mass Device - November 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Featured Imaging Software / IT HeartFlow Source Type: news

Medtronic readies pivotal trial in renal denervation
Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial. Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the around the renal arteries in treating hypertension, failed to meet its efficacy endpoint. The company suspended enrollment in its other Symplicity trials around the world and later took a $200 million write-down on its renal denervation assets. News of th...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Wall Street Beat Medtronic Renal Source Type: news

Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market. It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is the...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Biotronik Source Type: news