FDA issues breakthrough device designation for Philips’ laser-assisted IVC filter removal device

NETHERLANDS – Food & Drug Administration has granted Philips’ laser-assisted IVC filter removal device a breakthrough device designation (BDD). The proposed device is intended for ablating tissue to remove an IVC filter when previous methods of removal have failed. Under the BDD program, the FDA will provide Philips with priority review and interactive communication regarding device development throughout the submission process. The approval is based on recent research that supports the technology as two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99% effective with a major adverse…

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Philips’ strategic partnership with NicoLab set to accelerate stroke diagnosis and treatment

NETHERLANDS – Royal Philips, a global leader in health technology, has partnered with NicoLab, a MedTech stroke care company, to increase leverage on Philips’ stroke portfolio. Philips has a deep portfolio of stroke care solutions and a strong commitment to further innovation in this field. The partnership with NicoLab brings a cloud-based, end-to-end artificial intelligence (AI) based stroke triage and management solution, StrokeViewer, that aims to improve patient outcome by optimizing the stroke workflow. Together with the recently expanded stroke capabilities of Philips Image Guided Therapy System, Azurion, this new…

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Philips recalls ventilators, sleep apnea machines amid pandemic due to cancer related risks

NETHERLANDS – Dutch medical equipment company Philips has recalled some breathing devices and ventilators because of a foam part that might degrade and become toxic, potentially causing cancer. Philips Chief Executive, Frans van Houten, who said the company was one of the largest makers of sleep apnea machines and ventilators, recounted that up to 4 million worth of equipment will be recalled. Foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways, the group said, as it announced the recall. Gases released by the…

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