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Philips Receives FDA 510(k) Clearance on Image-Guided Surgical Therapy

by Syed Hamza Sohail 04/24/2024 Leave a Comment

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What You Should Know:

–              Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced its Philips Zenition 30 mobile C-arm has received FDA 510(k) clearance, making image-guided surgical procedures available to more US patients at lower cost.

–              By giving surgeons greater flexibility, control, and personalization of C-arm movement and user settings, Zenition 30 reduces their dependency on support personnel, helping alleviate staff shortages that limit patient access and increase waiting times.

Advanced Imaging and Control with Zenition 30

Enhanced Workflow and Budgetary Relief: The Zenition 30 addresses both budgetary constraints and workflow efficiency in hospitals by reducing the need for support staff during procedures. Surgeons can treat more patients while dedicating more time to each, improving both patient and staff experiences.

Superior Imaging with Dose Efficiency: Incorporating Philips’ latest flat detector technology and advanced imaging algorithms, Zenition 30 ensures superior image quality while minimizing X-ray exposure for patient and staff safety. Personalized user profiles and automatic workflow customization streamline procedures, reducing manual adjustments and improving imaging accuracy. Philips BodySmart software further enhances image consistency, particularly when targeting off-center anatomy.

Tailored Features for Specific Needs: Philips MetalSmart software adjusts image contrast and brightness for patients with metal implants, maintaining image quality while minimizing X-ray dose. Pediatric mode reduces dose rates for young patients. The system’s digital subtraction angiography capability enables clear imaging of vasculatures, enhancing its utility across a wide range of surgical procedures.

Enhanced Surgeon Control: With easily accessible pushbuttons on the flat detector, surgeons can control C-arm positioning during procedures, eliminating the need for manual effort to release and apply brakes. Usability studies show high confidence in the system’s enhanced control and personalized imaging profiles, indicating potential for greater independence and reduced image capture requirements during procedures.

Innovative Mobile Platform: The Zenition mobile C-arm platform consolidates advancements in image capture, processing, ease-of-use, and versatility, building upon Philips’ successful Zenition platform. Royal Philips is committed to leveraging health technology to improve people’s health and well-being through meaningful innovation, offering personal and professional health solutions for both hospital and home settings.

“Based on our Zenition platform’s proven ease of use and workflow efficiency, the new Zenition 30 offers a unique combination of personalized control and image clarity to enhance the speed and accuracy of decision making for a range of clinical procedures at a price point that meets today’s economic and business goals,” said Mark Stoffels, General Manager Philips Image Guided Therapy Systems.

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Tagged With: FDA clearance 510k

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