Reshape Lifesciences Achieves Critical Regulatory Milestones In Europe And The UK
$RSLS
ReShape Lifesciences (Nasdaq:RSLS), a leading provider of weight loss and metabolic health solutions, has recently announced a significant achievement in its regulatory compliance efforts. The company’s Quality Management System (QMS) and its entire range of medical devices available in Europe and the United Kingdom have been certified under the European Union (EU) Medical Device Regulation (MDR) and the UK Conformity Assessment (UKCA), respectively.
Hickey, President and Chief Executive Officer of ReShape Lifesciences, expressed pride in the company’s accomplishment, stating, “Achieving MDR and UKCA certification well ahead of the December 31, 2027, regulatory deadline establishes ReShape Lifesciences among a select group of medical device manufacturers that meet the EU’s rigorous new standards.” He highlighted the company’s investment in infrastructure to comply with the MDR’s demanding framework and to support ongoing innovation, ensuring uninterrupted access to the EEA markets.
Dov Gal, Vice President of Regulatory, Quality and Clinical Affairs at ReShape Lifesciences, also commented on the certification, noting the challenges faced by many legacy devices under the older MDD framework that were still awaiting MDR and UKCA certification. “With only a small percentage of applications resulting in approved certificates at that time, the risk of device shortages across the EU market became increasingly apparent,” Gal explained.
ReShape Lifesciences is known for its comprehensive portfolio of products and services that manage and treat obesity and metabolic diseases. Among its offerings are the FDA-approved Lap-Band® System, which provides a minimally invasive, long-term treatment of obesity as an alternative to more invasive surgical procedures like gastric bypass or sleeve gastrectomy.
Additionally, the company is developing the investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system, which utilizes proprietary vagus nerve block and stimulation technology for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology, another innovative non-surgical solution from ReShape, involves a swallowable, gas-filled intra-gastric balloon designed for long-lasting weight loss.
This regulatory milestone not only secures ReShape Lifesciences’ continued presence in the European market but also reinforces its mission to deliver safe, effective and innovative solutions to patients worldwide. The company continues to expand its product pipeline, these certifications will undoubtedly play a crucial role in its ability to provide cutting-edge treatments and to maintain a competitive edge in the global healthcare market.
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