Cyted gets FDA go ahead for oesophageal cancer diagnostic
More than 16,000 tests have been administered to patients in the UK. Credit: PongWang via Getty Images. UK-based gastrointestinal health firm Cyted has gained 510(k) clearance from the FDA for its non-endoscopic diagnostic test EndoSign. The EndoSign system picks up cells from the whole length of the digestive tract – the patient swallows a dissolvable […]
Genesis MedTech concludes US J-Valve study enrolment
The J-Valve TF System is intended to address the unmet needs of patients suffering from aortic valve regurgitation in the US. Credit: Natali _ Mis/shutterstock.com. Genesis MedTech has announced the completion of enrollment for its early feasibility study (EFS) in the US, evaluating the J-Valve TF System for patients with severe aortic regurgitation (AR). The […]
GMLx expands medical device logistics services in Atlanta
The GMLx’s new facility in Atlanta, US. Credit: PRNewswire/GlobalMed Logistix. GlobalMed Logistix (GMLx) has announced a significant expansion of its Atlanta campus in the US, increasing its operational footprint by 200% and introducing new services. The expansion, which includes a 65,000ft² facility, comes in response to the growing demand from healthcare companies for GMLx’s medical […]
Carthera kicks off pivotal trial with blood-brain-barrier opening device
Many drugs are not able to cross the blood-brain-barrier, reducing treatment efficacy. Image credit: Shutterstock/Jaray Sansed. Carthera has enrolled the first patient in a pivotal trial evaluating its low-intensity pulsed ultrasound (LIPUS)-based technology which helps drugs reach the brain in higher concentrations. The French medtech company is initially testing its SonoCloud device in patients receiving […]
Vektor raises $16m for artificial intelligence arrhythmia tool
Vektor’s vMap provides physicians with insights into patients arrhythmias. Credit: cagkansayin via Getty Images. Vektor Medical has raised $16m in Series A financing to expand its artificial intelligence (AI)-based computational electrocardiogram (ECG) mapping system, vMap. The Series A financing round was led by Solas BioVentures and TVM Capital Life Science. Vektor said the funding will […]
More guidance needed to use RWE to support device approvals in EU
It is possible to emulate the data and evidence quality of an RCT by using RWE if you establish a rigorous process to address the limitations of RWE, said Dr Andreas Beust. Image Credit: Phalguni Deswal / GlobalData. There is little to no guidance by the European Medicines Agency (EMA) regarding the advanced use of […]
High risk devices can be exempted from mandatory trials under EU MDR
Thomas detailed the four cases where a clinical investigation is not mandated under the EU MDR. Image Credit: Phalguni Deswal / GlobalData. A clinical investigation may not be mandatory for Implantable and Class III medical devices under Article 61(4)-(6) of the European Union Medical Device Regulation (EU MDR) if one of four cases apply to […]
Advancing diabetes management: why the insulin pumps & CGM market is growing
Insulin pumps and CGMs have played a crucial role in improving the lives of millions of individuals living with diabetes across the world, offering more convenient and precise methods of managing their blood glucose levels. According to GlobalData’s analysis, the global CGM and insulin pumps market was valued at $10.6 billion in 2022, which is […]
FEops HEARTguide shows to boost LAAO procedure efficiency
FEops HEARTguide is a cloud-based predictive procedure planning tool that offers clinicians and medical device manufacturers preoperative insights. Credit: MAD.vertise / Shutterstock.com. FEops has reported that data from a US-based comprehensive single centre experience where left atrial appendage occlusion (LAAO) procedures planned using the FEops HEARTguide demonstrated improved procedural efficiency. The recent evaluation was conducted […]
Aevice Health partners with AI firm to develop asthma monitoring device
The collaboration between the companies is partly funded by the UK government’s Innovate UK business grant scheme alongside Singapore’s, Enterprise Singapore. Credit: Shutterstock / Antonio Guillem An artificial intelligence (AI) driven remote monitoring system designed to predict exacerbations in asthmatic patients has gone into production as part of a deal between the UK and Singapore. […]