MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

Thursday, October 12, 2023

MCRA, LLC, a prominent regulatory advisory firm and clinical research organization (CRO) specializing in medical devices, has proudly announced its pivotal role in assisting Attune Medical with obtaining a De Novo marketing authorization from the US Food and Drug Administration (FDA) for the ensoETM™ device. This innovative device is designed to mitigate the risk of ablation-related esophageal injuries resulting from radiofrequency cardiac ablation procedures.

Attune Medical's ensoETM is a disposable thermal regulation device placed within the esophagus, similar to a standard orogastric tube. It is connected to an external heat exchange unit, forming a closed-loop system for proactive temperature management. This successful marketing authorization introduces a new Product Code, broadening ensoETM's classification as a temperature regulation device for esophageal protection during cardiac ablation procedures. This development represents a significant leap forward in the clinical approach to RF cardiac ablations, potentially benefiting numerous patients.

MCRA's regulatory expertise, complemented by its extensive services covering clinical trial operations, reimbursement, market access, healthcare compliance, cybersecurity, quality assurance, and Japan distribution logistics, has played a pivotal role in achieving this milestone. MCRA's commitment to fostering trust and collaboration with its clients, such as Attune Medical, is crucial in expediting the safe introduction of innovative medical devices to a wider market, ultimately enhancing patient care. This achievement underscores the dedication and proficiency of MCRA's regulatory team and their unwavering focus on advancing healthcare.


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