Hospi Corporation, a patient-centric medical device company, announced that it has received CE Mark approval – Conformité Européenne, which is required for sale of medical products in the EU and other international countries – for the company’s flagship product, the Macy Catheter. Hospi also received ISO 13485 Certification, demonstrating that its quality systems conform to world-class standards.
“These developments support our plans to broaden distribution of the Macy Catheter and our continued commitment to quality,” said Igal Ladabaum, CEO at Hospi. “The CE Mark approval is an important milestone and we’re thrilled to be able to bring the many benefits of the Macy Catheter to patients and providers in Europe. As a medical device innovator and manufacturer, we take quality very seriously and we are very pleased with the recognition that ISO 13485 certification provides.”
The innovative Macy Catheter is the only device designed solely for ongoing rectal delivery of medications and fluids. It offers clinicians and caregivers an easy, discreet, and comfortable alternative to oral or intravenous (IV) administration in a variety of settings when patients are unable to swallow. The Macy Catheter received Food and Drug Administration (FDA) clearance in 2014 and is being used by hospice and palliative care organizations throughout the United States. More recently, published research has demonstrated that the Macy Catheter can be effectively used in the emergency room and intensive care unit settings.
“While we focus our direct commercial efforts in the United States, we look forward to working with distribution partners in Europe and other markets where the CE mark is required,” said Ladabaum.