• Strategy
  • Payers
  • AI
  • Cybersecurity
  • Device Development
  • Studies/Published Research
  • Ethics
  • Regulatory
  • Digital Biomarkers
  • Data Science
  • Companion Diagnostics
  • Clinical Care
  • Digital Therapeutics
  • Academic Research
  • Virtual Reality
  • RWE
  • Digital Endpoints
  • Medical Devices (Class II and Class III)
  • Commercialization
  • Clinical Trials
  • Drug-Device Combinations
  • SaMD
  • Remote Patient Monitoring
  • Patient Engagement
  • Profiles/Q&A

MCRA Aids Attune Medical on FDA Marketing Authorization for Esophageal Thermal Regulating Device

News
Article

EnsoETM is designed to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

Human Body Organs (Stomach Anatomy). Image Credit: Adobe Stock Images/magicmine

Image Credit: Adobe Stock Images/magicmine

MCRA, LLC, medical device focused regulatory advisory firm and clinical research organization (CRO), announced that it will be assisting Attune Medical with its De Novo marketing authorization from the FDA. Specifically, it will focus on the ensoETM device, which was created to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

"Attune Medical's team put their trust in collaborating with the Cardiovascular team at MCRA to ensure the most rigorous and analytic approach to requesting De Novo marketing authorization from the US FDA,” said Fernando Aguel, VP, heart failure and circulatory support, MCRA. “Our team worked diligently to strategize accordingly, bringing in our decades of FDA expertise and industry knowledge to help achieve a positive result for our client. We are thrilled to have been a part of Attune Medical's label expansion for the ensoETM device."

Reference: MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device. PR Newswire. October 11, 2023. Accessed October 11, 2023. https://www.prnewswire.com/news-releases/mcra-assists-attune-medical-on-fda-de-novo-marketing-authorization-for-ensoetm-esophageal-thermal-regulating-device-301953014.html

Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.