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. Read More
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. Read More
What does the landscape look like in terms of funding for digital health? Geoffrey Starr, a partner at Cooley LLP, dove into this question during the Digital Health Summit, part of CES 2020. He acknowledged that 2019 saw a slight dip in funding compared with the record-breaking previous year. With that said, it was the second largest year ever for digital health care financings, with more than one-third of all health care venture financings involving digital health technologies. Read More
HONG KONG – South Korean-based med-tech Lunit Inc., of Seoul, has secured ₩30 billion (US$25.6 million) in series C funding. Founded in 2013, the Korean company has raised $50 million so far. Lunit’s corporate value was evaluated at as much as ₩200 billion as of the fundraising. Read More
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. Read More
