Daily CSR https://www.dailycsr.com/ us 2026-07-15T07:35:09+02:00 tag:https://www.dailycsr.com,2026:rss-97341076 Newronika αDBS Receives CE Mark for Adaptive DBS System Tue, 14 Jul 2026 12:12:00 +0200 us Debashish Mukherjee Newronika αDBS Receives CE Mark for Adaptive DBS System
Newronika S.p.A., a Milan-headquartered medical technology company specializing in advanced deep brain stimulation (DBS), has secured CE Mark certification for the newest commercial version of its αDBS adaptive DBS system. The updated platform now features complete integration with WebBioBank, the company's proprietary cloud-based platform for neural data management.

The certification represents a significant regulatory achievement, making αDBS the first adaptive DBS system approved to continuously monitor neural activity, automatically tailor stimulation based on each patient's therapy settings, and securely transmit this information to a fully integrated cloud-based neural data platform.

Developed through more than two decades of research and innovation, Newronika's technology is designed to interpret the brain's electrical signals and optimize therapy delivery. The system aims to improve treatment effectiveness while minimizing side effects, reducing the frequency of clinical appointments, and easing the overall care burden for both patients and healthcare professionals.

"This certification validates our vision of a fully connected, data-driven approach to neuromodulation therapy, and opens a new era in personalized treatment for patients living with Parkinson's disease and other neurological conditions," said Lorenzo Rossi, PhD, Co-Founder, CEO and CTO of Newronika.

Unlike conventional DBS systems that provide constant stimulation regardless of changes in a patient's neurological state, αDBS® dynamically adapts therapy in real time. Using its patented Adaptive Therapy Stim Engine, the system continuously monitors local field potentials (LFPs), interprets neural activity, and automatically fine-tunes stimulation to help patients remain within their ideal therapeutic range.

The αDBS platform combines an implantable pulse generator (IPG), a physician programming interface, and a patient remote control that supports convenient at-home data collection. Together, these components create a connected care ecosystem in which patient information is transmitted continuously, providing clinicians with long-term data that can help refine treatment strategies over time.

WebBioBank Powers Personalized Neuromodulation
A key feature of the newly certified release is the complete integration of WebBioBank, Newronika's dedicated neural data platform, with the αDBS® implant. The cloud-based system gathers and analyzes neuronal activity alongside clinical information from participating healthcare centers, creating a growing repository of anonymized longitudinal data that expands with each new patient.

Initially developed with funding from the Italian Ministry of Education and validated through peer-reviewed scientific research, WebBioBank has contributed to a deeper understanding of the neurophysiology of deep brain structures, the mechanisms underlying DBS therapy, and the development of next-generation adaptive stimulation algorithms. By providing a common analytical platform for clinicians, researchers, and Newronika, the system supports ongoing advances in personalized neuromodulation treatments.

The platform incorporates a robust de-identification framework designed to safeguard patient privacy while enabling secure data sharing across participating medical centers.

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Medtronic plc, a leading global healthcare technology company, announced its financial performance for the third quarter (Q3) of fiscal year 2026, which concluded on January 23, 2026.

Q3 Highlights
  • Revenue reached $9.0 billion, reflecting an 8.7% reported increase and 6.0% organic growth, surpassing Q3 guidance by 50 basis points.
  • GAAP diluted EPS was $0.89, while non-GAAP diluted EPS came in at $1.36, exceeding the midpoint of guidance by three cents.
  • The company reaffirmed its FY26 organic revenue growth and EPS outlook.
  • Cardiac Ablation Solutions revenue surged 80% overall and 137% in the U.S., driven by strong demand for the pulsed field ablation (PFA) portfolio.
  • Medtronic obtained CE Mark approval for Sphere-360™ and launched a U.S. pivotal clinical trial.
  • The company received FDA clearance for the Hugo™ robotic-assisted surgery platform, with initial procedures completed during the month.
  • Stealth AXiS™ Surgical System also gained FDA clearance for spine surgery applications.
  • Diabetes business revenue increased 8.3%, supported by strong double-digit growth internationally.
  • Two strategic acquisitions were completed during the quarter: CathWorks in Coronary and Renal Denervation and Anteris in Structural Heart.
Geoff Martha, Medtronic’s chairman and CEO, stated that Q3 delivered solid organic revenue growth above expectations, underscoring the strength of the company’s product portfolio. He highlighted Medtronic’s expansion into new markets, investments in high-growth areas, and a robust innovation pipeline as key drivers for sustained long-term growth.

Financial Performance
Medtronic reported Q3 global revenue of $9.017 billion, up 8.7% reported and 6.0% organically. Organic growth figures exclude certain items, including other revenue, divestiture impacts, and foreign exchange benefits.

Revenue by segment:
  • Cardiovascular Portfolio: $3.457 billion, up 13.8% reported and 10.6% organically, with strong growth in Cardiac Rhythm & Heart Failure and moderate gains across Structural Heart, Aortic, Coronary, and Peripheral Vascular.
  • Neuroscience Portfolio: $2.558 billion, up 4.1% reported and 2.5% organically, driven by Neuromodulation and Cranial & Spinal Technologies, with Specialty Therapies flat.
  • Medical Surgical Portfolio: $2.173 billion, rising 4.9% reported and 2.7% organically, supported by Surgical & Endoscopy and Acute Care & Monitoring.
  • Diabetes: $796 million, increasing 14.8% reported and 8.3% organically.
Profitability
  • GAAP operating profit: $1.464 billion (16.2% margin)
  • Non-GAAP operating profit: $2.177 billion (24.1% margin)
  • GAAP net income: $1.143 billion; GAAP EPS: $0.89
  • Non-GAAP net income: $1.750 billion; Non-GAAP EPS: $1.36
FY26 Outlook
Medtronic reaffirmed its FY26 organic revenue growth target of about 5.5% and non-GAAP diluted EPS guidance of $5.62–$5.66. The outlook includes an estimated $185 million tariff impact, unchanged from prior guidance. Excluding tariffs, the company expects approximately 4.5% EPS growth for FY26.

Chief Financial Officer Thierry Piéton noted that the company continued to accelerate growth while investing heavily in R&D, pursuing strategic acquisitions, and improving operational efficiency to support sustainable expansion.

Webcast and Financial Materials
Medtronic will host a video webcast on February 17 at 8:00 a.m. EST to discuss business performance with investors and media. The webcast, replay, transcript, and financial schedules will be available on Medtronic’s Investor Relations and News websites.

Click here to know more.

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