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.
The U.S. FDA granted Edap Tms SA breakthrough device designation for its Focal One system to treat deep infiltrating rectal endometriosis. The company believes that the Focal One high intensity focused ultrasound technology can offer relief to the thousands of women suffering from the debilitating condition.
Phagenesis Ltd. raised $42 million in a series D financing round for its neurostimulation therapy, Phagenyx, which treats swallowing dysfunction. The funds will primarily support commercialization of the device in the U.S. where there is a huge unmet clinical need in dysphagia treatment, Reinhard Krickl, CEO of Phagenesis, told BioWorld.
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.
Amber Therapeutics Ltd. revealed positive data from the first-in-human investigation of its Amber-UI device, an implantable closed-loop bioelectrical therapy for urinary incontinence. Initial results highlight the safety and scalability of the Amber-UI therapy, which has the potential to meaningfully improve quality of life for patients dealing with the condition.
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.
Mainstay Medical Holdings plc raised $125 million in equity financing which it will use to conduct clinical trials and continue the commercial roll out of its Reactiv8 neurostimulation therapy that treats chronic lower back pain.
The $110 million that Medical Microinstruments Inc. (MMI) recently raised in its series C funding round is testament to its unique position in microsurgery, said Olivier Litzka, a board member at MMI and a partner at Andera Partners. “There are not many companies actually working in that space in robotics,” he told BioWorld.
Woven Orthopedic Technologies LLC secured a second U.S. FDA 510(k) clearance for the use of its Ogmend implant enhancement system in spine surgery. The approval is for the large size Ogmend sleeve which is compatible with pedicle screws up to 10.5 mm and will give surgeons a tool to be able to easily secure stable fixation between the screw and bone during orthopedic surgery.
