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Medical Device Network2d
FDA approves Element Science’s application for Jewel Patch defibrillator
The US FDA has approved Element Science’s premarket approval (PMA) application for its Jewel Patch Wearable Cardioverter ...
Medical Device Network2d
Neurogen and NeuroX partner on early Alzheimer’s detection
Neurogen Biomarking has announced a collaboration with NeuroX to support patients’ journey on its brain health care ecosystem ...
Medical Device Network2d
OcuSciences gains FDA clearance on retinal health scanner
The US Food and Drug Administration (FDA) has cleared OcuSciences’ retinal health assessment device, the OcuMet Beacon.
Medical Device Network3d
HeartBeam’s ECG technology shows promise in study for arrhythmia diagnosis
HeartBeam’s synthesised 12-lead ECG has met the clinical endpoints in the VALID-ECG pivotal study, assessing ...
Medical Device Network3d
FDA approves Edwards’ TAVR system for asymptomatic aortic stenosis patients
The FDA has approved Edwards Lifesciences' SAPIEN 3 TAVR platform for the treatment of patients with asymptomatic severe ...
Medical Device Network3d
Canada’s UHN and U of T develop skin-based test for PSP diagnosis
Canada’s UHN and U of T researchers have created a skin-based test that identifies progressive supranuclear palsy (PSP) ...
Medical Device Network3d
RetinAI and FVS’ retinopathy screening algorithm gains CE-MDR certification
LuxIA, an AI algorithm co-developed by RetinAI US and FVS, has achieved CE-MDR certification for diabetic retinopathy (DR) ...
Medical Device Network2d
GE HealthCare warns of $500m revenue loss due to tariffs
GE HealthCare is expecting its 2025 revenues to take a hit of around $500m due to the Trump administration’s imposition of ...
Medical Device Network4d
AI-automated IVF procedures represent a new era in fertility treatment
A baby has been born following an AI-automated in vitro fertilisation (IVF) procedure conducted remotely by engineers and ...
Medical Device Network3d
New £1bn cancer research hub planned for South London
The London Cancer Hub has been identified as a key district for ‘frontier innovation’ by London Mayor Sadiq Khan.
Medical Device Network5d
FDA grants breakthrough status to Roche’s VENTANA TROP2 device
The US FDA has granted breakthrough device designation to Roche's companion diagnostic VENTANA TROP2 (EPR20043) RxDx Device.
Medical Device Network5d
Sequel strikes deal with Senseonics for one-year CGM system
Sequel’s twiist will become the first automated insulin delivery system to integrate with Senseonics' one-year CGM system.