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GALWAY, Ireland - Medtronic plc (NYSE:MDT), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $115.42 billion, has announced the FDA approval of its innovative BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI) for patients with Parkinson’s disease in the United States. According to InvestingPro data, the company maintains a strong financial health score, positioning it well for continued innovation in medical technology. This groundbreaking technology adjusts DBS therapy in real-time based on individual brain activity, representing a significant advancement in personalized treatment for the over one million Americans living with this neurological condition.
Deep brain stimulation (DBS) has been instrumental in managing Parkinson’s symptoms for over three decades. Medtronic’s Percept™ DBS neurostimulators now incorporate BrainSense™ Adaptive technology, which allows the system to automatically adjust therapy without manual intervention by patients or clinicians. With annual revenue of $33.2 billion and an impressive gross profit margin of 65.57%, Medtronic continues to demonstrate its commitment to advancing medical technology. This adaptive system is the first of its kind and is touted as the largest commercial launch of brain-computer interface technology to date.
The FDA’s decision follows a comprehensive international clinical trial, ADAPT-PD, which assessed the safety and effectiveness of aDBS compared to continuous DBS (cDBS). The trial’s methodology and sensing data have been published in npj Parkinson’s Disease, part of the Nature Portfolio.
The BrainSense™ Electrode Identifier (EI) also approved by the FDA, streamlines the initial programming of DBS devices, reportedly performing 85% faster than traditional methods. This tool aids clinicians in accurately and efficiently determining optimal settings for individual patients, thus enhancing the precision of therapy.
Medtronic emphasizes that its BrainSense™ technology offers unique insights into a patient’s condition by monitoring brain signals in real-time. The company’s commitment to creating solutions tailored to real-life scenarios is reflected in the development of aDBS, which is expected to set a new standard in Parkinson’s treatment.
Patients in the United States will have access to BrainSense™ aDBS and EI in the upcoming weeks at select healthcare systems, with nationwide availability anticipated in the following months. The technology is also available in Europe. For investors interested in deeper analysis of Medtronic’s market position and growth potential, InvestingPro offers comprehensive research reports and additional insights, including more than 10 exclusive ProTips about the company’s financial strength and market performance.
Medtronic, with a history of serving more than 185,000 individuals with movement disorders and other conditions since 1987, continues to innovate in the field of neuromodulation. The company advises patients considering DBS therapy to consult with their healthcare providers regarding treatment options.
This announcement is based on a press release statement from Medtronic plc.
In other recent news, Medtronic PLC (BVMF:MDTC34) reported its third-quarter earnings for fiscal year 2025, revealing an adjusted earnings per share (EPS) of $1.39, which surpassed analyst expectations of $1.36. However, revenue fell short of forecasts, coming in at $8.29 billion against the anticipated $8.33 billion. Despite the EPS beat, the company’s revenue miss has raised concerns among investors. Stifel analysts maintained a Hold rating on Medtronic with a price target of $87, noting that the company’s third-quarter revenues slightly missed expectations due to distributor de-stocking in the Surgical Innovations division. UBS analyst Danielle Antalffy raised Medtronic’s price target to $95 from $85, maintaining a Neutral rating, and highlighted positive momentum in the company’s Diabetes and Cardiac Ablation Solutions segments. Medtronic’s management remains optimistic, citing confidence in the strength of its core businesses and the belief that the distributor de-stocking is a one-time event. The company has expressed expectations of a revenue and EPS growth acceleration in the fourth quarter, driven by innovations like the HUGO Robotic Platform and Renal Denervation. These developments provide a nuanced view of Medtronic’s current financial landscape and strategic direction.
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