The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.
Dublin-based Medtronic plc received a CE mark for its Percept PC neurostimulator to treat neurologic disorders such as Parkinson’s disease. It is the first deep brain stimulation system launched in the EU that integrates the company’s technology to sense and record brain signals, known as Brainsense. It’s intended to enable more personalized treatment driven by that data.
Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.
LAS VEGAS – The U.S. FDA has said it is looking to help those interested in developing digital health tools, and that commitment took center stage this week during the Digital Health Summit, part of CES 2020. Amy Abernethy, principal deputy commissioner at the FDA, gave an overview of the agency’s thinking on the topic, providing the perspective of someone who came from outside the regulatory world.
Caesarea, Israel-based Icecure Medical Ltd. has won the FDA’s nod for additional indications for its cryoablation technology, paving the way for use in kidney, liver, ear, nose and throat and new neurology indications. The agency also cleared Icecure’s new Multisense system.
Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see.
Neovasc Inc., of Richmond, British Columbia, has submitted a premarket approval application to the U.S. FDA for its Neovasc Reducer. The minimally invasive stent, which was granted breakthrough status in October 2018, is used to treat refractory angina.
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