Latest news with #EUCE
Yahoo
08-07-2025
- Health
- Yahoo
Morphic Medical obtains CE mark for obesity treatment
Morphic Medical has obtained an EU CE mark for RESET, a device designed to target the underlying cause of obesity and type 2 diabetes (T2D). The Boston-headquartered company's RESET is a novel duodenal-jejunal bypass liner (DJBL) that mimics the effect of gastric bypass surgery and is positioned as a less-invasive option for people with T2D and obesity who have not responded well to medications or require a 'bridge' ahead of bariatric surgery. Implanted endoscopically into the upper region of the small intestine and left in place for up to nine months, RESET creates a physical barrier between receptors in the intestinal wall and food. The approach has been demonstrated to improve weight reduction and metabolic conditions by enhancing natural hormones in the gut in a manner comparable to glucagon-like peptide-1 (GLP-1) agonists. A UK study conducted at the Sandwell and West Birmingham National Health Service (NHS) Trust demonstrated that RESET's use in individuals with diabetes and obesity resulted in an average weight reduction of 17.4kg at the three-year follow up after receiving the treatment, and a 1.9% reduction in blood glucose levels alongside improvements in blood pressure and cholesterol. Morphic Medical president and CEO, Joseph Virgilio commented: "This critical regulatory milestone is an important step toward delivering on our promise and accomplishing our mission to alleviate the symptoms of obesity and metabolic disorders such as T2D for patients fighting these global epidemics. 'We're excited to help patients who have failed to achieve their goals through a programme of diet, exercise, and medical management, and are looking for an alternative therapy.' RESET is currently only available for investigational use in the US. To support a regulatory filing with the US Food and Drug Administration (FDA), Morphic is currently enrolling patients in the STEP-1 RESET pivotal trial (NCT04101669). Planned for completion in 2026, STEP-1 is a multi-centre, randomised, sham-controlled trial that plans to enrol a total of 264 patients to evaluate the safety and effectiveness of RESET, as per the study's listing on "Morphic Medical obtains CE mark for obesity treatment" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
The Sun
02-07-2025
- Automotive
- The Sun
Supratechnic appointed as exclusive distributor for Hidea outboard motors in Malaysia, Singapore
KUALA LUMPUR: Supratechnic (M) Sdn Bhd, a wholly-owned indirect subsidiary of Singapore mainboard-listed USP Group Ltd, and Malaysia's distributor of marine engines, hardware, and related maritime services, signed an exclusive distribution agreement with Hangzhou Hidea Power Machinery Co Ltd, China's leading outboard motor manufacturer. Effective July 1, 2025, the agreement grants Supratechnic sole distribution rights for Hidea's full range of outboard motors, parts, and accessories across Malaysia and Singapore. Under this strategic partnership, Hidea will provide comprehensive technical training and spare parts support, ensuring robust servicing readiness and excellent customer support across Supratechnic's extensive service network. 'We are honoured to partner exclusively with Hidea, a brand that embodies engineering excellence, environmental sustainability, and cost-efficiency,' Supratechnic CEO Melvin Tan said. 'This collaboration not only strengthens our market position but also empowers us to deliver broader, more innovative marine options across Malaysia and Singapore, supported by superior after-sales service and technical expertise,' he said. Hidea operates advanced marine engine manufacturing facilities in Hangzhou, China. Known for its pioneering anti-corrosion technology, robotic automation systems, and high production consistency, Hidea exports over 70% of its 100,000-unit annual output to more than 80 countries, including Europe, North America, and Australia. All products meet international standards and certifications, including ISO9001, EU CE, and US EPA. The partnership includes strategic co-branded marketing opportunities and joint participation in national marine expos to enhance Hidea's visibility in the region. Supratechnic will immediately roll out internal training sessions for its sales and technical teams, implement a nationwide launch campaign aligned with the agreement's effective date, and coordinate logistics, stock planning, and branch allocations based on projected demand. 'We are proud to partner with Supratechnic, one of Southeast Asia's most established and trusted marine distributors,' Hidea founder and executive chairman Zheng Huali said. 'Their deep market knowledge and strong after-sales infrastructure make them an ideal partner as we expand our footprint in Malaysia and Singapore. 'At Hidea, we are committed to delivering highly stable commercial outboard motors, exceptional service, and cost-effective high-horsepower models — engineered to perform reliably in the region's demanding marine conditions,' he said.
Focus Malaysia
01-07-2025
- Automotive
- Focus Malaysia
Supratechnic appointed as Hidea Outboard Motors exclusive distributor in Malaysia, Singapore
SUPRATECHNIC (M) Sdn Bhd, Malaysia's premier distributor of marine engines, hardware and related maritime services, has today (July 1) sealed an exclusive distribution agreement with Hangzhou Hidea Power Machinery Co Ltd, China's foremost and leading outboard motor manufacturer. Today's agreement grants the wholly-owned indirect subsidiary of Singapore Mainboard-listed USP Group Ltd sole distribution rights for Hidea's full range of outboard motors, parts and accessories across Malaysia and Singapore. Under this strategic partnership, Hidea will provide comprehensive technical training and spare parts support, thus ensuring robust servicing readiness and excellent customer support across Supratechnic's extensive service network. 'We are honoured to partner exclusively with Hidea, a brand that embodies engineering excellence, environmental sustainability and cost-efficiency,' commented Supratechnic's CEO Melvin Tan. ALL SYSTEMS GO: (Form left) Supratechnic (M) Sdn Bhd CEO Melvin Tan Wei Yang and Hidea Power Machinery Co Ltd founder & executive chairman Zheng Huali 'This collaboration not only strengthens our market position but also empowers us to deliver broader, more innovative marine options across Malaysia and Singapore while being supported by superior after-sales service and technical expertise.' Hidea currently operates one of the world's most advanced marine engine manufacturing facilities in Hangzhou, China. Known for its pioneering anti-corrosion technology, robotic automation systems and high production consistency, Hidea exports over 70% of its 100,000-unit annual output to more than 80 countries, including Europe, North America and Australia. All its products meet international standards and certifications including ISO9001, EU CE and US EPA. The Supratechnic-Hidea partnership entails strategic co-branded marketing opportunities and joint participation in national marine expos to enhance Hidea's visibility in the region. Supratechnic (M) Sdn Bhd's headquarters in Shah Alam Towards this end, Supratechnic will immediately roll out internal training sessions for its sales and technical teams, implement a nationwide launch campaign aligned with the agreement's effective date as well as coordinate logistics, stock planning and branch allocations based on projected demand. Meanwhile, Hidea's founder & executive chairman Zheng Huali is proud to partner with Supratechnic which he described as 'one of Southeast Asia's most established and trusted marine distributors'. 'Their deep market knowledge and strong after-sales infrastructure make them an ideal partner as we expand our footprint in Malaysia and Singapore,' envisages Zheng. 'At Hidea, we're committed to delivering highly stable commercial outboard motors, exceptional service and cost-effective high-horsepower models which are engineered to perform reliably in the region's demanding marine conditions.' – July 1, 2025
United News of India
12-06-2025
- Business
- United News of India
Renalyx launches world's first indigenous AI-based Smart Hemodialysis Machine
Pune, June 11 (UNI) Renalyx Health Systems Pvt. Ltd., a pioneering technology innovation company in renal care, has launched RENALYX – RxT 21, the world's first fully indigenous, AI and cloud-enabled smart hemodialysis machine with real-time remote monitoring and clinical connectivity facility. RENALYX – RxT 21 will make dialysis affordable and accessible to a larger population and bridge the demand-supply gap in the renal care across semi-urban and rural regions. Completely designed and manufactured in India, RENALYX – RxT 21 leverages latest technologies including cloud-based telenephrology platforms to offer safety and quality care to kidney patients, end-stage renal disease (ESRD) patients especially those with cardiovascular, pulmonary and acute kidney injury-related issues, said release today. RENALYX – RxT 21 makes Renalyx the sixth company globally and first in India to produce an advanced dialysis machine with EU CE certification. Renalyx has plans to invest INR 800 crores in the next four years to build the manufacturing capacity of 5,000 machines by FY25-26 and will develop additional capacity of 1500 machines by FY27-28. The company also has plans to manufacture consumables indigenously. The company has manufacturing facilities at Bengaluru and Mysuru in Karnataka and at Mumbai in Maharashtra to support its scale-up plans and meet the growing demand. The company plans to raise funds through the sale of equity, backed by strong interest from prominent Indian and international investors. In addition, it will raise debt, and the promoters will also invest capital. Renalyx also has plans to go public within the next three years, said the release. UNI SP RN
New Indian Express
11-06-2025
- Business
- New Indian Express
Renal care firm Renalyx to invest Rs 800 crore in Karnataka manufacturing plants
MUMBAI: Bengaluru-based Renalyx Health Systems, which is into renal care, has launched what it claims to be the world's first fully indigenous, AI and cloud-enabled smart hemodialysis machine with real-time remote monitoring and clinical connectivity facility. The company also claimed that they are the sixth in the world and the first company in the country to produce an advanced dialysis machine with EU CE certification. The company has also announced Rs 800 crore of investments in its Bengaluru manufacturing facility over the next four years. Called the Renalyx RxT 21, the machine comes for Rs 6.70 lakh, which is significantly lower than the price of imported machines, thus helping make dialysis affordable and accessible to a larger population and bridge the demand-supply gap in the renal care across semi-urban and rural regions.
