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Fractyl Seeks to Turn Diabetes On Its Ear with Revita DMR
Fractyl Seeks to Turn Diabetes On Its Ear with Revita DMR
Jun 03, 2020
The Lexington, MA-based company won an IDE from FDA to launch a pivotal trial of the study. Revita DMR is a same-day, outpatient endoscopic procedure that uses heat to resurface the lining of the upper intestine in a minimally invasive, outpatient...
New EUA Places Abiomed Firmly in the COVID-19 Conversation
New EUA Places Abiomed Firmly in the COVID-19 Conversation
Jun 01, 2020
Abiomed said it was granted Emergency Use Authorization for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism. The Danvers, MA-based company initially received...
Medtronic Issues Recall for HVAD Pump Outflow Graft
May 29, 2020
The Dublin-based company is recalling the HeartWare HVAD pump outflow graft and outflow graft strain relief because of the risk of breaks and tears during the pre-implant pump assembly process. FDA has identified this as a Class I recall.
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