Regulatory harmonization and reliance are the orders of the day at this year’s meeting of the International Medical Device Regulators Forum (IMDRF), but that does not mean individual regulators are waiting for IMDRF to act on their own imperatives.
The U.K. government said it will take action to tackle potential bias in the design and use of medical devices after an independent review found that there is extensive evidence of poorer performance of certain technologies, like pulse oximeters, in patients with darker skin tones.
Rehab Technologies Lab recently unveiled a new robotic exoskeleton, Twin, designed for lower limbs to allow patients with spinal cord injuries to walk independently. Although Twin is currently a prototype, the company will work towards getting CE mark to bring it to the market to help patients with physical impairments integrate back into social and work environments.
Researchers from the University of Edinburgh seek protection for an algorithm developed using artificial intelligence that could be used by doctors to diagnose heart attacks more quickly and effectively.
Rhythm Diagnostic Systems SA received CE mark approval from EU authorities for Multisense, a wearable device that continuously monitors patients remotely. The company looks to market the device first in France and Germany.
In a sign that Royal Philips NV is not letting the problems in its business in the U.S. stop its innovation, the company has launched the Azurion neuro biplane, a new image guided therapy system for patients suffering from stroke and other neurovascular diseases. It also teamed up with Syntheticmr AB and launched Smart Quant Neuro 3D, an AI imaging tool which will help health care professionals diagnose and assess brain disorders like multiple sclerosis, traumatic brain injury and dementia.
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.
The U.K.’s National Institute for Health and Care Excellence (NICE) has given people looking to lose weight another treatment option by recommending endoscopic sleeve gastroplasty (ESG) as a therapy to help treat obesity. The move comes amidst increasing awareness of the disease brought on by the growing prevalence of GLP-1 agonists.
The €173 million (US$187 million) in capital that Earlybird Health recently raked in from investors will go towards bolstering investment in European health care startups, many of which are still recovering from the impact of COVID-19, Thom Rasche, a partner at Earlybird Health, told BioWorld. The fund is looking to invest in the technologies that can improve patient care.
Through its intellectual property holding company, Eindhoven, the Netherlands-based Bambi Medical BV is seeking patent protection for an enhancement to its flexible sensor belt that is worn around the abdomen for monitoring the vital signs of neonates.