Enable Injections expands manufacturing with 90,000ft² facility
The expansion follows market clearance of Enable’s EnFuse wearable injector system and a renovation of the company’s headquarters. Credit: Shutterstock / Alexander Lukatskiy. US-based wearable tech company Enable Injections has confirmed plans to expand to a 90,000ft² manufacturing center as it looks to expand its Cincinnati headquarters. The company said that the expansion will help […]
Inspira’s blood oxygenation system receives US patent approval
Traditional fibre oxygenators force blood through layers of fibres, creating a turbulent flow that can lead to high haemolysis. Credit: NPW-STUDIO/shutterstock.com. Inspira Technologies has received US patent approval for its orbiting blood oxygenation delivery system (VORTX). This system is a key component of the INSPIRA ART500 device, which is designed to enable breathing in patients […]
Work begins on Terumo’s VCD facility in Puerto Rico
The VCD is designed to ensure rapid haemostasis following angiographic or interventional procedures. Credit: MAD.vertise/shutterstock.com. Terumo Medical has commenced construction on a new manufacturing facility at its site in Caguas, Puerto Rico, to address the rising global demand for its Angio-Seal VCD The expansion, which includes a 64,000ft² addition and the renovation of an existing […]
US FDA grants breakthrough status to Efemoral’s vascular device
The device works by addressing the specific anatomic challenges, as well as complex biomechanics of individuals living with athero-occlusive disease in the leg. Credit: Valerio Pardi / Shutterstock.com. The US Food and Drug Administration (FDA) has granted breakthrough device status to Efemoral Medical’s Efemoral vascular scaffold system (EVSS). This designation is intended for the treatment […]
SCOPE: Changing protocol language and site actions are key to making trials inclusive
The panel at SCOPE discussed tried and tested ways in which trials can be made more inclusive. Image credit: Abigail Beaney/GlobalData Changing the language used in trial protocols and continually conversing with sites are some ways by which trialists can make clinical research more inclusive of the LGBTQIA+ community, say experts. On the fourth and […]
UK Government invests £10m to rush devices to market
The UK Government has invested £10m across a selection of medical technologies in a move to bring them to market faster. Credit: Shutterstock / chrisdorney. The UK Government has invested £10m ($12.5m) across a selection of medical technologies in a move to bring them to market faster. The spending comes as part of the UK’s Department […]
ZKR Orthopedics secures IDE approval for LIFT implant US trial
It is suggested that up to a third of knee arthritis originates in the patellofemoral compartment. Image credit: Shutterstock/fongbeerredhot. The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to ZKR Orthopedics to begin a pivotal trial evaluating its implant for later-stage patellofemoral cartilage degeneration treatment. The US company has designed an […]
AI company Deepc acquires Osimis radiology imaging software
The acquisition has the added benefit for Deepc of further consolidating its place in the rapidly growing AI imaging market. Credit: Shutterstock / Dmitry Kalinovsky. Deepc, a Munich-based AI-driven software company for radiologists, has announced that it has acquired medical imaging software, the Osimis Platform. Deepc’s bespoke operating system for radiology, DeepcOS, is designed to […]
Testing, testing: the advancing diagnostics for sexually transmitted infections
The CDC recently found a sharp increase in the rates of sexually transmitted syphilis, which rose from 113,739 in 2018, to 203,500 in 2022, representing a five-year rise of 78.9%. Credit: Shutterstock / unverdorben jr. Sexually transmitted infections (STIs) have seen a rise in the years following the Covid-19 pandemic, with 2022 seeing more than […]
FDA green lights Masimo’s fingertip pulse oximeter
Masimo’s MightySat Medical fingertip pulse oximeter, which has been cleared by the FDA. Credit: Masimo via Businesswire. The US Food and Drug Administration (FDA) has granted clearance to health tech company Masimo’s MightySat Medical fingertip pulse oximeter, the first FDA-approved medical fingertip pulse oximeter that patients can buy without an over-the-counter prescription. The oximeter uses […]