Philips Zenition 90 Motorized receives FDA 510(k) clearance, helping clinicians deliver high quality care with a high-powered and fast motorized mobile C-arm
Royal Philips announced the FDA 510(k) clearance of its Zenition 90 Motorized mobile C-arm. This innovative system enhances clinical efficiency with high-powered imaging (25 kW) and intuitive motorization designed for complex vascular and various clinical procedures such as cardiac interventions, pain management, and urology.
The Zenition 90 Motorized offers automated workflows and touch screen controls to give clinicians greater flexibility and independence. Usability studies show high satisfaction among clinicians, with 100% reporting complete table-side control and 97% noting time savings during procedures. The new system also boasts a 25% improvement in product life and a 13% increase in power efficiency compared to its predecessor.
- FDA 510(k) clearance enhances market credibility.
- High-powered imaging (25 kW) supports complex procedures.
- Automated workflows improve clinical efficiency and save time.
- Table-side controls provide greater flexibility and independence for clinicians.
- Positive feedback from clinicians: 100% reported complete control, 97% noted time savings.
- 25% increase in product life and 13% power efficiency improvement.
- Showcased at 2024 Society for Vascular Surgery Annual Meeting, enhancing visibility.
- availability in select countries could restrict market reach.
- Optional features may increase total system cost.
Insights
The FDA 510(k) clearance for Philips Zenition 90 Motorized C-arm system signals a noteworthy development in the medical device industry. This clearance is an essential regulatory milestone, meaning the device has been shown to be substantially equivalent to a legally marketed device. For clinicians, the high-power (25 kW) motorized features and automated workflows of the Zenition 90 can signify an improvement in procedural efficiency and image quality, especially during complex vascular procedures. This leads to better patient outcomes due to enhanced visualization capabilities.
In the short term, Philips' existing relationships with healthcare providers could see a boost in purchasing decisions, driven by the enhanced features and functionalities. In the long term, the device's sustainability features, like improved product life and power efficiency, highlight Philips' commitment to eco-friendly innovations, potentially attracting environmentally conscious buyers and reducing long-term operational costs for hospitals.
Overall, the integration of the Zenition 90 into clinical settings can enhance operational workflows, save time and improve patient care quality, which is fundamental for healthcare providers.
Philips' launch of the Zenition 90 Motorized C-arm system comes at a time when the demand for advanced imaging solutions is growing. The improvements in workflow efficiency and image quality could potentially place Philips ahead of competitors like Siemens and GE in the mobile C-arm market. The FDA clearance further strengthens Philips' position, as regulatory approvals often give companies a competitive edge.
From a market perspective, the introduction of a high-powered, motorized mobile C-arm system aligns well with the increasing complexity and volume of interventional procedures. This trend can drive higher adoption rates and increase Philips' market share. However, potential drawbacks might include the high cost of such advanced systems, which could limit adoption among smaller clinics and hospitals with tighter budgets.
Investors should note the importance of regulatory approvals in the medical device market, as they can significantly impact a company's financial performance. Philips' ability to navigate the FDA's regulatory landscape and bring innovative products to market is a positive indicator of its operational capabilities and future growth potential.
June 17, 2024
- Intuitive motorization for greater control and high-power (25 kW [1]) for state-of-the-art image quality supports complex vascular needs and a full range of clinical procedures
- Automated workflows contribute to greater flexibility and independence for clinicians, providing more time to focus on achieving the best possible outcomes for patients
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of Philips Image Guided Therapy Mobile C-arm System 9000 – Zenition 90 Motorized, designed to help clinicians deliver high-quality care to more patients. Philips is partnering with its customers to improve productivity. The new mobile C-arm with expanded capabilities is designed to meet complex vascular needs, but also a range of clinical procedures such as cardiac interventions, pain management and urology. Philips will be showcasing its newly introduced mobile C-arm at the 2024 Society for Vascular Surgery Annual Meeting, June 19-22, in Chicago.
Increased control and efficiency with automated workflows
The Philips Zenition Image-Guided Therapy Mobile C-arm Systems bring together innovations in image capture and processing, ease-of-use, and versatility, many of which were pioneered on Philips’ highly successful image guided therapy platform Azurion. Motorized and impressively fast, the Zenition 90 Motorized is an intuitive C-arm that allowsclinicians to control it from the table-side with user-friendly controls and time-saving features – empowering the clinician with greater flexibility and independence. It delivers state-of-the-art image quality for the most challenging procedures and is designed to meet complex procedural needs. The system allows greater clinical efficiency thanks to its automated workflows, the image controls via the Touch Screen Module and the advanced software solutions.
“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,” said Mark Stoffels, Business Leader Philips Image Guided Therapy Systems. “The new Zenition 90 Motorized empowers medical teams to confidently perform a wide range of interventions while achieving the best possible outcome for their patients.”
In independent hands-on usability studies of clinicians from the US and EU with the Zenition 90 Motorized in simulated environments;
As part of its commitment to sustainability and providing customers with responsible choices, Philips leveraged its EcoDesign process for the Zenition 90 Motorized to improve product life by
Philips latest image guided therapy mobile C-arm system is also available in a non-motorized configuration.
[1]Also available in 15 kW
[2] Results obtained during claims substantiation study performed in June 2022 and May 2023 by Use-Lab GmbH, an independent company. Response is based on 25 physicians from the EU and the US, who answered a questionnaire after a usability study with additional hands-on time with the system.
[3] Results obtained during claims substantiation study performed in June 2022 and May 2023 by Use-Lab GmbH, an independent company. Response is based on 49 clinicians from the EU and the US, who answered a questionnaire after a usability study with additional hands-on time with the system.
[4] Compared to its predecessor, Zenition 70
- Zenition 90 Motorized and Zenition 90 are available for sales in a limited number of countries.
- Some features are optional for Zenition 90 Motorized and Zenition 90.
- Actual product representation may vary.
For further information, please contact:
Joost Maltha
Philips External Relations
Tel. : +31 6 10558116
E-mail: joost.maltha@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
Attachments
- Physicians using the Zenition 90 Motorized mobile X-ray system
- Physicians using the Zenition 90 Motorized mobile X-ray system during an intervention
- System image of Philips Zenition mobile X-ray solution
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