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Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided. ....
Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation. ....
Clarius Mobile Health Inc. received CE mark for its latest wireless hand-held whole-body ultrasound scanner, the Clarius PAL HD3. The scanner combines both phased and linear arrays on a single head which provides high image quality of superficial and deep anatomy allowing for better diagnostic capabilities and patient care. ....
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions. ....
Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure. ....