Regulatory compliance in MedTech is not getting harder because the regulations are new. It is getting harder because most organisations are still managing it the same way they were ten years ago. Columbus has mapped the four stages of digital compliance maturity, identified where most MedTech compan
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
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, promotes DHSC hosted sector engagement opportunities on value-based procurement (VBP). MedTech suppliers are being invited to engage with officials from the Medical Technolog
The prestigious national Medilink UK Healthcare Business Awards 2026 will celebrate the achievements of some of the most innovative life sciences organisations in the UK, at the iconic Victoria House, Bloomsbury Square, London on Thursday 9th July. Each year, Medilink UK regional organisations host
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, predicts changes to the focus of the NHS under a possible future Andy Burnham premiership. We know that Andy Burnham is prepared to think big. In 2009, as the then Health and
Fifteen NHS trusts across the West Midlands are a significant step closer to leveraging diagnostic expertise on a scale never seen before in the health service, after the largest digital health initiative of its kind in Europe commenced a procurement process. Formally known as the Converged Digital
