How is Europe’s MedTech industry navigating the EU MDR?
The upcoming Outsourcing in Clinical Trials: Medical Devices Europe 2023 conference will dissect the challenges and opportunities for running medical device trials in Europe and the impact of AI in the field. Image Credit: Arena International Events Group The technical documentation requirements of the EU’s Medical Device Regulation (EU MDR) can be exhaustive and resource-consuming. […]
Providence’s CAVUX FFS-LX system receives FDA approval
The CAVUX FFS-LX integrated cage and screw system. Credit: PRNewswire/ Providence Medical Technology. Providence Medical Technology has received US Food and Drug Administration (FDA) clearance for its CAVUX FFS-LX Lumbar Facet Fixation System, designed for lumbar spinal fusion surgery. CAVUX FFS-LX is an integrated cage and screw system that can be implanted bilaterally in the […]
The need for speed: Faster medical device timelines with the right coating
Speed is of the essence for new medical devices entering the market – and the coating plays a vital role. Delays in the commercial launch of a medical device can have a serious impact on the bottom line and impede revenue generation. For a smaller company, bringing in this revenue is what will ultimately secure […]
Integer acquires contract manufacturer Pulse Technologies
Pulse Technologies serves various markets including structural heart, heart pump and leadless pacing. Credit: Yurchanka Siarhei/Shutterstock.com. Integer has acquired Pulse Technologies, a contract manufacturer specialising in complex micro machining of medical device components, for $140m. Based in the US, Pulse Technologies serves various markets including structural heart, neuromodulation, electrophysiology, heart pump and leadless pacing. The […]
Distalmotion, Proximie on robotic surgery platform extension
Distalmotion’s Dexter surgical robot. Credit: Distalmotion. Distalmotion has announced a partnership with Proximie, a health technology platform, to globally extend the capabilities of its Dexter robotic surgery system. The collaboration will provide customers of Distalmotion with access to Proximie’s healthcare platform, which is designed to offer telepresence, content management and data-driven insights. By integrating Dexter […]
3Spine completes enrolment in lumbar fusion device trial
The trial comes off the back of two other trials consisting of 151 completed lumbar total joint replacement surgeries and 174 real-world posterior lumbar fusions. Credit: Shutterstock / Roman Zaiets Tennessee-based medical device firm 3Spine has announced that it has completed the enrolment in a clinical trial set to pave the way for regulatory clearance […]
Ultromics partners with Pfizer to advance EchoGo AI technology
The EchoGo Amyloidosis algorithm utilises deep learning to analyse echocardiograms. Credit: PRNewswire/Ultromics. UK-based health technology company Ultromics has announced a partnership with Pfizer to expedite the development and pursue US Food and Drug Administration clearance for its artificial intelligence (AI) platform to detect cardiac amyloidosis. Referred to as EchoGo Amyloidosis, the platform leverages AI for […]
The crucial intersectionality of sexual health and prenatal screening
Screenings occur in the first and second trimesters. Credit: Jirsak via Shutterstock. National Birth Defects Awareness and Prevention Month is observed in January, and it is vital to recognise the intersection of prenatal screening and sexual health. The two are interconnected, with prenatal screenings important in ensuring the well-being of the expectant parent and their […]
Meeting plated components demand: Why Alleima is scaling up its Swiss operations
Alleima has had considerable success since it became a standalone company more than a year ago and has continued to deliver its strategy of driving profitable growth and operational sustainability. Through a series of acquisitions, including nitinol experts Endosmart, the company continues to expand its capabilities. The medical unit within Alleima specialises in ultra-fine medical […]
Hyperfine introduces new AI-powered software for brain imaging
Hyperfine’s Swoop is a portable, ultra-low-field, magnetic resonance brain imaging system. Credit: Business Wire/ Hyperfine, Inc. Medical device company Hyperfine has launched its AI-powered eighth generation of the Swoop system software for improved brain imaging. This software, which has received both CE and UK Conformity Assessed (UKCA) approval, features an FDA-approved diffusion-weighted imaging (DWI) AI […]