Le Lézard
Classified in: Health
Subject: FDA

Respinova Granted FDA 510(k) Clearance for Pulsehalertm


HERZLIYA, Israel, April 6, 2021 /PRNewswire/ -- Respinova Ltd. is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Pulsehalertm. Pulsehalertm is an innovative device that facilitates the opening of airways and clearance of secretions in patients with respiratory diseases.

"Despite the available pharma treatments, patients with COPD, Asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life," commented Professor Raphael Breuer, MD, former Head of the Institute of Pulmonology at Hadassah University Medical Center. "Pulsehalertm brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly", he added.

"This FDA clearance for Pulsehalertm is an important milestone for the company," said Cliff Ansel, CEO of Respinova Ltd.  "We are excited to bring this innovative technology to respiratory patients".

Pulsehalertm is the first device to use patented Dynamic Multi-frequency Pressure Pulsetm technology. Driven by an internal turbine and multi-frequency vibration disc, Pulsehalertm sends air pressure pulsations directly into the lung, making it easier to use for patients with airway restrictions.

About Respinova Ltd.:

Respinova is a privately held medical technology company based in Herzliya, Israel. Our team has decades of experience in developing and commercializing innovative medical devices in diverse therapeutic areas. Respinova is a two-time winner of the prestigious European Horizon program (Horizon 2020 SME and Horizon EIC).

Contact:

Cliff Ansel, CEO
[email protected]
www.respinova.com

 

 

SOURCE Respinova Ltd.


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