Health Canada authorises Abbott's Esprit BTK system for CLTI
Health Canada has granted authorisation for Abbott’s Esprit BTK Everolimus Eluting Resorbable Scaffold System.| Medical Device Network
The FDA is seeking industry comment on practical approaches towards evaluating the performance of AI-enabled medical devices in the real world. The post FDA seeks industry feedback on AI medical device safety monitoring appeared first on Medical Device Network.| Medical Device Network
GE HealthCare’s Vivid iq ultrasound system has been sent to the International Space Station (ISS). The post GE HealthCare’s Vivid iq ultrasound system heads to space appeared first on Medical Device Network.| Medical Device Network
Europe's healthcare sector faces a dual challenge: delivering high-quality care while managing rising energy costs and reducing carbon emissions. Hospitals and clinics are energy-intensive operations – spending between €2,200 and €3,900 per bed annually on energy. That equates to roughly 2.1–10% of operating expenses, depending on the facility, and represents a significant strain on already tight budgets. The post Healthcare’s energy transition needs creative financing appeared firs...| Medical Device Network
The US Government has shut down for the first time since 2018 after a majority of Democrat senators refused to back Republican legislation that research suggests would result in higher healthcare premiums for millions of Americans. The post US Government shuts down over funding impasse appeared first on Medical Device Network.| Medical Device Network
RefleXion's radiotherapy technology controlled localised disease, while triggering no adverse events (AEs) rated Grade 2 or higher. The post RefleXion’s precision radiotherapy offers 100% local tumour control appeared first on Medical Device Network.| Medical Device Network
The US FDA has granted 510(k) clearance to Zenflow’s Spring Scope & Camera Control Unit (CCU), a single-use cystoscope. The post FDA grants 510(k) clearance to Zenflow’s single-use cystoscope appeared first on Medical Device Network.| Medical Device Network
Natus Medical has acquired the remaining shares of Holberg EEG, securing full ownership of the company, to boost neurological diagnostics. The post Natus fully acquires Holberg EEG to boost neurological diagnostics appeared first on Medical Device Network.| Medical Device Network
Active Life Scientific has gained 510(k) clearance from the US Food and Drug Administration (FDA) for OsteoProbe, a tool for minimally invasive bone tissue quality assessment. The post FDA clears Active Life’s bone tissue assessment tool appeared first on Medical Device Network.| Medical Device Network
RDS has raised €14m ($16.4m) to accelerate the European market roll-out of MultiSense, a remote patient monitoring (RPM) wearable. The post RDS raises €14m to bolster market penetration of patient monitoring wearable appeared first on Medical Device Network.| Medical Device Network
Health Canada has granted authorisation for Abbott’s Esprit BTK Everolimus Eluting Resorbable Scaffold System.| Medical Device Network
Despite Boston Scientific’s pulse field ablation (PFA) system Farapulse demonstrating strong efficacy from the FARADISE registry study, the trial’s principal investigator says that data also indicated that surgeons are using the device beyond recommendations.| Medical Device Network
PAVmed has signed a non-binding letter of intent with Duke University to license an oesophageal imaging technology.| Medical Device Network
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The European Patent Office (EPO) has granted patent no. 3,697,298 to Autonomix Medical’s catheter-based technology| Medical Device Network
The rise of agentic artificial intelligence (AI) is liable to have multiple use cases for healthcare in patient-facing areas including remote monitoring, but it will also bring new legal considerations along with it, an expert says.| Medical Device Network
The upcoming EpiPen patent expiration on 11 September 2025 sets the stage for a pivotal shift in the epinephrine delivery market.| Medical Device Network
The US Federal Trade Commission (FTC) is suing Edwards Lifesciences to stop it from acquiring JenaValve, citing anticompetitive concerns.| Medical Device Network
A key trend in the medical device market is smaller and smarter, which requires advanced materials and is the focus of the latest podcast from Alleima Medical.| Medical Device Network
The US FDA has conditionally approved TransMedics Group’s IDE to commence the next-generation OCS ENHANCE Heart study.| Medical Device Network
To realise the potential of medical device data and maintain security protocols in a more connected medtech reality, network architecture must evolve.| Medical Device Network
Becton, Dickinson and Company (BD) has announced a trial utilising the BD Libertas Wearable Injector for subcutaneous delivery of biologics.| Medical Device Network
Becton, Dickinson and Company (BD) has announced its submission of an application to the FDA for an at-home human papillomavirus (HPV) test.| Medical Device Network
The use of artificial intelligence (AI) and generative AI (GenAI) in the healthcare space is skyrocketing.| Medical Device Network
Axonius has acquired New York-headquartered healthcare cybersecurity firm Cynerio in a $100m cash and stock deal.| Medical Device Network
How can medical device companies improve the sustainability of clinical products?| Medical Device Network
Discover the leading Medical Plastics Manufacturers for the Medical Industry. Download the free Buyer's Guide today for full contact detials.| Medical Device Network
Discover leading Sales & Marketing Intent Data Solutions for the medical device industry. Download the free Buyer's Guide for full details.| Medical Device Network
AI technologies are pushing the boundaries of what constitutes a medical device. Historically, a medical device was defined by its physical characteristics and intended use, but AI introduces complexities that challenge this traditional framework.| Medical Device Network
Firefly Neuroscience is now a non-exclusive distributor for Zeto’s pair of EEG-headsets, called WR19 and Zeto ONE.| Medical Device Network
CVRx has reported durable improvements in heart failure patients with its Barostim device over 24 months.| Medical Device Network
The Class I recall was issued following reports of false negative responses and was linked with 10 reported injuries.| Medical Device Network
Abbott has entered a partnership to integrate its FreeStyle Libre CGM technology with smart insulin pen systems of Medtronic.| Medical Device Network
