Attune Medical wins 510(k) clearance for drug-delivery model of EnsoETM esophageal device

Attune Medical said today that it won 510(k) clearance from the FDA for a new model of its EnsoETM device capable of administering tube feeds or medication while regulating a patient’s temperature through the esophagus.
The newly-approved model allows clinicians to maintain a patient’s core temperature while simultaneously administering fluids, eliminating the need for a separate feeding tube.
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Source: Mass Device - January 8, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Drug-Device Combinations Endoscopic / Arthroscopic Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance attunemedical Source Type: news