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Guardant Health gets EU IVDR certification for Guardant360 CDx blood test
The certification is for tumour mutation profiling in individuals with any type of solid cancerous tumour and covers companion diagnostic indications for certain cancers
AiM Medical Robotics and BWH collaborate on DBS robot trial
The trial will see the use of AiM Medical Robotics’ stereotactic neurosurgery robot to deliver DBS leads with real-time MRI guidance for Parkinson’s Disease patients
AngioDynamics obtains CE Mark for AlphaVac F18⁸⁵ System to treat PE
The AlphaVac F18⁸⁵ System is now approved in Europe for the non-surgical removal of thrombi or emboli from the pulmonary arteries and reduce thrombus burden
DentalMonitoring gets FDA De Novo approval for remote monitoring software
The medical device software analyses images of the oral cavity using advanced image processing algorithms, DM App, smartphone, and other proprietary hardware products
HeartBeam AI with VCG outperforms cardiologist panel in atrial flutter detection, says HeartBeam
HeartBeam’s AI algorithm with VCG outperformed the EP panel, showing a statistically significant 40% improvement in the rate of atrial flutter detection compared to single-lead ECGs, and exhibited a 6% enhancement over an expert panel reviewing 12-lead ECGs
Laborie launches Solar Compact System and Solar AMC for gastrointestinal diagnostics
The Solar Compact System and Solar Anorectal Manometry Catheter are designed to diagnose defecatory disorders and pelvic-floor dysfunction related to constipation and faecal incontinence
Medtronic’s Affera system with Sphere-9 Catheter meets key endpoints in AFib trial
The Sphere-9 Catheter showed an excellent primary safety endpoint rate of 1.4% with no major safety events and 73.8% freedom from AFib against 65.8% in the control arm
Owlet Announces UK Medical Certification of Dream Sock
The UKCA certification, granted by a recognized UK-approved body, follows the recent announcement of Owlet’s EU CE mark certification of Dream Sock earlier this month and now provides Owlet with medical device certifications in key UK and European markets where its distribution partners operate
Coloplast expands its Luja portfolio with next generation catheter for women
Following the successful launch of Luja with Micro-hole Zone Technology, a next generation intermittent catheter for men, Coloplast is now launching Luja for women
Siemens Healthineers announces £250m Oxford facility, the UK’s first major production site for new MRI cooling technology
Construction begins for new site to design & manufacture MRI superconducting magnets