AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. The investigational technology uses Lead I ECG dat
Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has named long-time medtech executive Trent Reutiman as its new CEO. Based in California’s San Francisco Bay Area, Reutiman will establish a
Sequana Medical NV, a specialist in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces that it has received Premarket Approval (PMA) from the US Food and Drug Administration (FDA) to market alfapump for the treatment of recurrent or refractory
TOSS Machine Components, Inc., a manufacturer and distributor of impulse heat sealing components and supplies, has announced the launch of its new advanced seal and cut heat seal bands. Designed to address the specific needs of the medical and life sciences industry, TOSS claims its seal and cut ban
The Association for the Advancement of Medical Instrumentation (AAMI) has published AAMI TIR17:2024; Compatibility of materials subject to sterilisation. Last updated in 2017 to address an urgent need for information sharing, AAMI TIR17 is relevant to medical device manufacturers, product designers,
Leading health and human performance clinic Marylebone Health has announced the introduction of new, more accessible VO2 max testing technology from Danish MedTech startup VentriJect. The group will be using VentriJect’s Seismofit device, which estimates VO2 max in under three minutes without the n
The Golden Jubilee University National Hospital has become the first hospital to co-design friendly and reusable theatre caps made from sustainable plant-based material as part of a research project being led by the University of Strathclyde and Heriot-Watt University. The project aims to reduce was
Laura Friedl-Hirst, Founder, Managing Director and Principal Consultant at LFH Regulatory discusses the main regulatory changes in the UK and the EU over the past 12 months. The requirements for medical device and in vitro diagnostic are constantly evolving, especially with changes such as the Unite
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, looks ahead at what the coming year holds for the MedT
Stewart Hyde, Executive Vice President of Sales – Europe for Dycem talks to MTI about the company’s contamination control mats for cleanrooms and the technology behind them, as well as looking ahead to regulatory trends in 2025. Q. Describe the products that Dycem offers A. Dycem is committed to pro
by Brian Tifft, Program Manager, Applications Development ; and Dr. Jean Daou, Research & Development Manager, EMEA Advancements in medical device sterilisation have been slow in coming – until recently. Medical device sterilisation is a critical process in healthcare, ensuring that instruments and
During Formnext 2024, LPE, a leader in additive manufacturing, announced the addition of a second Axtra3D Lumia X1 printer to its fleet. This milestone makes LPE the first company worldwide to operate two of these machines. The company says this latest investment is designed to meet the growing dema
