Diagnostics company Neuro Event Labs Oy (NEL) has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for clinical use of its Nelli Seizure Monitoring System in the hospital setting. Nelli, recognised by the FDA as a Breakthrough Device, is the world’s first non-c
NHS Supply Chain is supporting the NHS to treat cancer patients quicker with the supply of 28 ‘cutting edge’ new linear accelerator (LINAC) radiotherapy systems in 2025/26 to NHS cancer centres across the country. The rollout of the new technology is backed by centralised government funding provided
Martin Murphy, Principal Consultant at 42 Technology explains what impact the FDA’s upcoming new regulation will have on drug delivery device developers. The regulatory world of medical devices is undergoing one of the most significant transformations in nearly three decades. The long-standing Quali
Editor Oli Johnson speaks to HiArc President Nate Doemling about the role the company plays in product development for life sciences companies, offering a tactical guide on avoiding common design and regulatory missteps. Earlier this year, HiArc rebranded from its previous name, KMC Systems, as the
Neuraxpharm Group, a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, and mjn-neuro, a start-up that designs, manufactures and markets medical devices, have announced the upcoming launch of EPISERAS, a digital health solution desig
The UK has just seen the first case of treatment for benign prostatic hyperplasia (BPH) with Rezūm Water Vapour Therapy using the newly launched Rezūm EVO Console at Basingstoke and North Hampshire Hospital. BPH is a non-malignant condition which causes an urgent need to urinate, difficulty starting
Leading digital diagnostics company PocDoc has partnered with Romanes Pharmacy Group to increase access to cardiovascular disease (CVD) screening in Scotland. Through the new partnership, residents can book an in-person CVD screening at any of Romanes’ 8 branches across the Scottish Borders and East
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, looks at the impact of a major grant from the Wellcome Trust to fund development of new standards for digital mental health apps. UK medical
After the Autumn 2025 budget was announced by Chancellor of the Exchequer Rachel Reeves, Med-Tech Insights reached out to contacts in the industry for comment on what it would mean for the healthcare space, as well as being inundated with comments from the wider life sciences sector. Mark Leftwich,
Queen Victoria Hospital NHS Foundation Trust (QVH), a specialist hospital providing life-changing reconstructive surgery, burns care and rehabilitation services, has gone live with its first electronic patient record (EPR) system. The partnership with Altera Digital Health successfully launched the
UK-based charity Keep Me Breathing (KMB) has unveiled VENTO, a breakthrough non-invasive wearable CO2 monitor that it says marks a major step forward in respiratory technology for people born with Congenital Central Hypoventilation Syndrome (CCHS) and other rare breathing disorders. KMB says that VE
Elizabeth Norwood, Senior Chemist at MicroCare, LLC, outlines the impact of contamination on optical signal transmission, the role of electrostatic attraction in persistent debris, and the importance of adopting industry-approved inspection and cleaning standards like IEC 61300-3-35. Norwood advocat
