Medical Device News

Phagenyx System Receives FDA Approval

Phagenyx® System Is Designed to Accelerate Removal of the Breathing Tube by Treating Neurogenic Dysphagia

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Phagenesis Ltd. has announced today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx System is a novel neurostimulation device that helps to restore neurological swallowing control through Pharyngeal Electrical Stimulation.

The FDA Breakthrough Device Program is intended to help patients and health care providers receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Phagenesis with priority review and interactive communication during the Phagenyx De Novo review phase.

Reinhard Krickl, CEO of Phagenesis, said: “Receiving Breakthrough Device Designation is a key milestone, validating Phagenyx as a unique solution to accelerate decannulation that addresses a substantial unmet medical need currently causing negative consequences for risk of pneumonia. This will lead to timely and successful rehabilitation, better patient comfort and positively impact on number of days in the hospital, hospital readmissions and the financial cost of care.”

The Phagenyx System treats the cause of dysphagia. In tracheotomised patients weaned from mechanical ventilation, severe dysphagia with related insufficient airway protection is the primary reason why decannulation cannot be performed. The PHAST-TRAC1 randomized controlled study, published in Lancet Neurology in 2018, demonstrated that tracheotomized patients treated with the Phagenyx System were 5 times more likely to be safely decannulated when compared with untreated control patients.

Greg Behar, CEO of Nestlé Health Science, commented: “Nestle Health Science has been working with Phagenesis for several years in Europe to build the clinical evidence for this treatment and we are excited that the Breakthrough Device Designation will help to accelerate the process of making Phagenyx available to US patients also.”

Note: * Phagenyx® is CE marked in Europe. In the United States, Phagenyx® is currently not available for sales.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.

Valencia Technologies Announces CMS Publication of 2025 Medicare Proposed Rule for eCoin® Procedure

Ann Decker, VP of Reimbursement for Valencia Technologies, stated, "The cumulative effect of the proposed 2025 continuation of APC assignment 5464, the improved ASC payment rate, and the recognition of ITNS as a minimally invasive OAB treatment option in the recently updated guidelines by the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), underscores that the eCoin ITNS system will have a strong reimbursement pathway throughout 2025 and beyond.