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Medical Devices DECODED

Latest edition: 15 May 2024
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Spotlight

FDA issues recall notice for Philips after another respiratory device fails

The FDA has issued the notice for the company’s Trilogy EVO Continuous Ventilators, warning that they are liable to be ‘battery depleted’ despite being connected to power and halting therapy.

Latest news

Meacor secures $15m for heart valve repair technology development

The technology is poised to provide an effective solution to halt regurgitation.

Saladax receives approval from Health Canada for 5-FU TDM test

The My5-FU test allows for patient-specific dose adjustments, thereby improving efficacy and reducing toxicity.

Innovate UK funds digital health compliance platform

Innovate UK has awarded the London and Amsterdam-based startup £322k to boost digital healthcare compliance in the NHS.

PhotoPharmics brings in first PD patients for phototherapy device trial

PhotoPharmics is aiming to enrol 300 patients with Parkinson’s disease in a pivotal trial evaluating its phototherapy device.

Brixton Biosciences secures $33m to develop osteoarthritis pain platform

The company will use the capital to initiate two new clinical studies into its pain management platform.

Somnee launches new features of smart sleep headband

The app for the smart sleep headband introduces features such as brain mapping, a sleep journal, and sleep readiness scores.

Profound wins FDA clearance for AI support to Tulsa system

iCAD, Inc, a global medical technology leader providing innovative cancer detection and therapy solutions, announced that ProFound AI Version 3.0 for Digital Breast Tomosynthesis (DBT) was cleared by the U.S. Food and Drug Administration (FDA). Compared to previous versions of the software, the ProFound AI 3.0 algorithm offers up to a 10% improvement in specificity performance and up to 1% improvement in sensitivity. ProFound AI Version 3.0 also offers up to 40% faster processing on the new PowerLook platform.

15th Annual Outsourcing in Clinical Trials East Coast 2024

The upcoming Outsourcing in Clinical Trials Europe 2024 conference will explore advancements in the clinical trial industry.

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