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EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation

Legacy MEDSearch

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Often, conservative treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. Food & Drug Administration (FDA).

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Hyperfine, Inc. Announces FDA Clearance for Improved AI-Powered Software and Expanded Field of View for the Swoop® Portable MR Imaging® System

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. We are committed to continuous improvement to optimize the clinical utility of the Swoop® system while driving commercial adoption across leading institutions globally. Hyperfine, Inc.,

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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

Food and Drug Administration for commercial use in the United States. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. For more information, please visit: www.NeuroLogica.com.

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Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Legacy MEDSearch

Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”. Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021.

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MicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications

Legacy MEDSearch

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.