Zinger Key Points
- ReShape's full EU and U.K. device portfolio now certified under MDR and UKCA.
- Company meets updated regulatory requirements before 2027 deadline.
- Get access to the leaderboards pointing to tomorrow’s biggest stock movers.
ReShape Lifesciences RSLS stock is trending up on Tuesday. Here’s what investors need to know.
The premier physician-led weight loss and metabolic health solutions company’s Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the U.K. have been certified under the European Union (EU) Medical Device Regulation (MDR) (EU) 2017/745 and U.K. Conformity Assessment (UKCA), respectively.
The EU MDR, which replaced the Medical Device Directive (MDD) in May 2021, sets significantly more stringent requirements for clinical evaluation, post-market surveillance, and device traceability.
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Its goal is to improve patient safety, transparency and product quality across all 30 European Economic Area (EEA) countries.
The UKCA replaced the CE mark for certain goods placed on the market in Great Britain (England, Scotland and Wales). It ensures that products meet the U.K.’s regulatory requirements for safety, health and environmental protection.
“Achieving MDR and UKCA certification well in advance of the December 31, 2027, regulatory deadline is a significant milestone that firmly establishes ReShape Lifesciences among a select group of medical device manufacturers capable of meeting the European Union’s rigorous new standards,” stated Paul F. Hickey, president and CEO of ReShape Lifesciences.
In the first quarter of 2025, ReShape Lifesciences reported sales of $1.1 million, representing a contraction of 42.7%, or $0.8 million, compared to the same period in 2024.
This decrease in sales volume was primarily due to GLP-1 pharmaceutical weight-loss alternatives and a temporary pause in DTC marketing programs.
In May, ReShape Lifesciences declared a 1-for-25 reverse stock split.
In April, ReShape Lifesciences signed an agreement with Haifa to exclusively import and distribute their neuromuscular rehabilitation devices in the U.S.
The flagship product, the Stimel-03, was showcased at the American Occupational Therapy Association 2025 Annual Conference and Expo.
RSLS Price Action: ReShape Lifesciences stock is up 55.68% at $6.71 at publication on Tuesday.
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