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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

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