Medical Devices DECODED
Latest edition: 10 May 2024
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Spotlight
Neuralink's first brain chip implant faces setback
Despite the partial retraction, the patient was still able to use the implant to play chess on a computer using his thoughts.
Latest news
Tandem's insulin pump app glitch triggers FDA Class I recall
Tandem’s insulin pump iOS app crash caused the pump’s battery to drain and shut down resulting in 224 reported injuries leading to a Class I recall.
R3 Vascular secures funding to support bioresorbable scaffold trial
The company’s bioresorbable scaffolds are crafted from an ultra-high molecular weight polylactic acid polymer.
UK MHRA pilots AI Airlock regulatory sandbox
The MHRA has set out a system designed to test AI-driven devices in isolation, aimed at laying the groundwork for future regulation.
Freyja wins FDA clearance for VereSee device
The VereSee device is a 2mm abdominal-access video-entry device designed for laparoscopic surgery in women’s health.
OrthoXel's Vertex Hip Fracture Nail system obtains US clearance
OrthoXel’s system aims to provide a stable and versatile solution for surgeons.
ProAxsis awarded Innovate UK grant for respiratory monitoring
The grant will be used to develop ProAxsis’s respiratory diagnostics point-of-care range.
Reflow Medical eyes follow-up data in retrievable stent trial
Already CE marked, Reflow has completed enrolment in a US trial for its retrievable stent therapy device.
In our previous edition
Medical Devices Decoded
FDA issues warning on Getinge device amid quality concerns
09 May 2024
Medical Devices Decoded
Samsung to acquire foetal ultrasound AI software company Sonio
08 May 2024
Medical Devices Decoded
Medtronic's renal denervation system receives approval in China
07 May 2024
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