Median Technologies, manufacturer of eyonis, has announced eyonis LCS has obtained CE marking as a Class IIb medical device, under the new European Medical Device Regulation (MDR 2017/745), enabling commercialisation across the European Economic Area. The CE marking, granted by the French notified
Olympus Corporation has launched ENDOEYE ULTRA in Europe, the Middle East and Africa (EMEA). The latest addition to the company’s videoscope portfolio for minimally invasive surgery is designed to support both reliable visualisation during procedures and more efficient handling in the operating room
Camgenium has announced the launch of its Foundation Platform, a pre-certified infrastructure spanning firmware, cloud and compliance for connected medical device manufacturers. The platform provides security, connectivity, regulatory infrastructure and cloud hosting as a ready-built foundation, and
Medilink UK has announced the appointment of Sir Andrew Cash as its new chair, marking a significant milestone and strengthening Medilink’s position as the “largest representative body for the UK life sciences sector” according to the organisation. With more than 35 years of senior leadership experi
BrightHeart, a specialist in AI-driven prenatal ultrasound, has announced it has received the CE mark for its flagship medical devices, enabling commercialisation of the B-Right AI Platform across the European Union. The company will make its European debut at the Fetal Medicine Foundation (FMF) Wor
MiniMed, a global leader in diabetes technology, has announced the commercial launch in Europe of both the MiniMed 780G system integrated with the Instinct sensor and the MiniMed Go system integrated with the Instinct Go sensor. The Instinct and Instinct Go sensors, made by Abbott, will be rolled ou
Heartfelt Technologies has announced that the FDA has granted Breakthrough Device Designation to the first-of-its-kind Heartfelt device, an AI-powered home monitoring technology designed to identify worsening heart failure before patients require hospital care. The FDA Breakthrough Devices Program i
When radiology went digital in 2006, it created a massive wave of optimism for NHS digitisation. But why has replicating that success in other disciplines been so challenging? Sectra’s Chris Scarisbrick joins Med-Tech Insights Editor Oli to dive deep into the cultural and technical shifts happening
Spotlight Medical, a Paris-based oncology diagnostics company, has announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). The milestone advances Spotlight Medical’s European commercialisation strateg
BrightHeart, a global leader in AI-driven prenatal ultrasound, has announced it has received the CE mark for its flagship medical devices, enabling commercialisation of the B-Right AI Platform across the European Union. The company will make its European debut at the Fetal Medicine Foundation (FMF)
InHealth has become the first independent provider in Great Britain and Ireland the helium-independent MAGNETOM Flow.Elite MRI system from Siemens Healthineers within a hybrid relocatable imaging environment. The company says this marks an important step towards more flexible and sustainable approac
