Newronika Receives CE Mark Approval for AlphaDBS, Advancing Adaptive Deep Brain Stimulation for Parkinson's Disease
MILAN, March 24, 2025 /PRNewswire/ -- Newronika, a leader in neuromodulation and adaptive deep brain stimulation (DBS) technology, announced today that it has received CE Mark approval for its AlphaDBS device, a next-generation closed-loop DBS system that dynamically adjusts stimulation based on real-time brain signals. This approval enables the company to commercialize AlphaDBS in Europe, bringing an innovative treatment option to patients living with Parkinson's disease and other neurological disorders.
DBS is a proven therapy for managing many symptoms of Parkinson's disease and has been prescribed for a variety of neurological disorders. Hundreds of thousands of DBS implantations around the world have helped patients manage PD, dystonia, essential tremor, OCD, and more. Conventional DBS devices deliver continuous stimulation at fixed settings. While the therapy has been effective for decades, new techniques and technology have allowed for significant improvement to the customization of DBS therapy.
Newronika's AlphaDBS monitors the patient's brain activity and automatically adjusts stimulation levels in response to real-time neurophysiological feedback. This personalized approach optimizes symptom control while reducing side effects and minimizing the need for frequent programming adjustments by neurologists.
"The CE Mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation," said Lorenzo Rossi, CTO and Co-Founder of Newronika. "This certification validates our vision of bringing truly adaptive neuromodulation to patients. We are excited to bring this technology to market and to set a new standard in the treatment of Parkinson's disease."
The CE Mark approval is based on clinical data demonstrating the safety and effectiveness of the AlphaDBS in delivering adaptive deep brain stimulation. Clinical trials for adaptive DBS have shown that patients experience more time without symptoms or side effects compared to conventional DBS, with improved overall quality of life and greater patient preference for the adaptive stimulation mode.
With this regulatory milestone, Newronika is preparing for the commercial launch of AlphaDBS in select European markets in 2025. The company is also advancing its global expansion, including its recently announced Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial in the United States.
About Newronika
Newronika is a spin-off of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan, and s transforming deep brain stimulation (DBS) through its adaptive platform that uses real-time patient data to optimize therapy. Headquartered in Milan, Italy, the company is committed to advancing neuromodulation beyond conventional limitations. With ongoing research collaborations, a CE Mark for its technology, and now an Investigational Device Exemption from the FDA, Newronika stands at the forefront of next-generation therapeutic innovation for neurological disorders.
For more information, visit www.newronika.com or follow us on LinkedIn.
Logo - https://mma.prnewswire.com/media/2612569/5150136/Newronika_Logo.jpg
ContactMichael FattoreCFO+39 02 84109381info@newronika.com
View original content:https://www.prnewswire.com/news-releases/newronika-receives-ce-mark-approval-for-alphadbs-advancing-adaptive-deep-brain-stimulation-for-parkinsons-disease-302408062.html
SOURCE Newronika
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Popular Dried Fruit Recalled From 19 States for ‘Possible Health Risk
A recall of more than 300 cases of Floria Dried Apricots is underway due to a "possible health risk," the U.S. Food and Drug Administration said this week. Turkana Food Inc., which is based out of Kenilworth, New Jersey, pulled 352 cases of the dried fruit snack from shelves in 19 states, the FDA announced Thursday. The reason for the recall is that the packaging for the dried apricots did not indicate they contained sulfites. Sulfites are commonly used as a preservative in food and drinks, but some people could have allergic reactions to them. "The recall was the result of a routine sampling performed by the New York State Department of Agriculture and markets which revealed that the finished products contained Sulfites that were not listed on the product labelling," the FDA said. "The company has ceased production and distribution of the products as FDA and the company continue their investigation to correct the issue with the manufacturer." The 200-gram paper packaged apricots were taken off the market in Alabama, California, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas and Virginia. The packages of apricots contain the lot number '440090478-15-333' and universal package code label '2539560010." They list their expiration date as November 2026, per the recall notice. Anyone who bought the recalled apricots can return them to the place of purchase for a full refund. As of now, no illnesses have been reported. Popular Dried Fruit Recalled From 19 States for 'Possible Health Risk first appeared on Men's Journal on Jun 14, 2025
Yahoo
3 hours ago
- Yahoo
Polyshine Solar Shines at SNEC 2025 with Five Application- Specific Solutions
SHANGHAI, June 14, 2025 /PRNewswire/ -- The global PV and energy storage industry event, 2025 SNEC PV&ES was held in Shanghai, China. As an innovative leader in the field of lightweight PV modules, Polyshine Solar brings five application-specific solutions, enabling global industry professionals offered by lightweight PV Technology. New product debut: JG-Series Lightweight and flexible is the result of Polyshine solar's market research. Over the past few years, We have focused on solving application for low- load and curved surfaces. However, our observations reveal that "lightweight" is the core demand for most application scenarios. The JG-Series lightweight module utilizes a 1.1mm ultra-thin glass package, reducing weight by over 50% compared to traditional modules. With a module conversion efficiency of up to 23.3%, it provides a more cost-effective lightweight solution for a wider range of rooftops. Five Application-Specific Solutions Scenario 1: High Energy Consumption Plant Polyshine Solar's lightweight innovative solution addresses common challenges in traditional high energy-consumption plants, such as insufficient load-bearing capacity and curved structures. Weighing less than 5.5 kg/sqm, it significantly reduces roof pressure. With a 0.5m bending radius, it conforms to curved surfaces. Furthermore, its self-cleaning coating reduces PV plant maintenance, lowering operational costs and increasing revenue. Scenario2: Traffic Sound Barrier Noise Noise reduction, power generation, lightweight, safety! Polyshine Solar's traffic photovoltaic solution is designed for elevated roads. Using ultra-lightweight and safe materials, it combines noise reduction with high-efficiency power generation. This transforms road sound barriers from basic infrastructure into revenue generators! Scenario 3: Harbor Art Museums Art museums by the sea demand unique aesthetics, while the hot and humid coastal climate presents an extreme challenge for photovoltaic modules! Polyshine Solar's customizable color module solution meets the aesthetic requirements of landmark buildings. Our patented encapsulation technology reliably withstands harsh seaside environments. Scenario 4: Flower Market Polyshine Solar's double-sided translucent, lightweight, and flexible PV modules feature customizable light transmittance. Generating power on both sides to capture solar energy, they simultaneously provide optimal lighting conditions for crop growth. Scenario5: Balcony PV Struggling with difficult installation and high labor costs for residential PV solutions? Polyshine solar's balcony-specific PV module are designed for easy installation: simply secure them using cable ties. A single module can be installed by one person in just two minutes. They adapt to various balcony and garden railing, making it easy to start generating solar income. "Where light exists, there is Polyshine! " View original content to download multimedia: SOURCE Polyshine Solar CO.,LTD Sign in to access your portfolio
Yahoo
3 hours ago
- Yahoo
Dr Pepper Has Recalled Thousands of Cases of Soda
In perhaps the funniest mislabeling blunder ever, Pepsi Beverages Company is recalling over 19,000 cases of Dr Pepper Zero Sugar products because they actually do, in fact, contain sugar. Whoops! The Class II recall has a low risk of serious health consequences, but temporary or reversible effects may occur, according to the FDA. To date, no illnesses or adverse reactions have been reported. While the recall pertains to a large amount of product, the sodas in question were only distributed to retail locations in three states—Florida, South Carolina, and Georgia. The affected products were packaged in 12 fl oz. aluminum cans in both 12-pack and 24-pack cartons and have a "best by" date of February 16, 2026 and product code XXXXRS05165. While the average consumer might not have issues with accidentally consuming these mislabeled products, the error could indeed pose health risks for people with diabetes or anyone with conditions instructed to monitor their sugar intake. A can of regular Dr Pepper contains 39 grams of sugar, while Dr Pepper Zero Sugar, obviously is meant to contain zero. The latter does, however, contain artificial sweeteners and additional ingredients like aspartame, acesulfame potassium, and sodium phosphate. Good thing we have a doctor in the house. All recalled products should either be thrown away or returned to your place of purchase. You Might Also Like Can Apple Cider Vinegar Lead to Weight Loss? Bobbi Brown Shares Her Top Face-Transforming Makeup Tips for Women Over 50
