The U.S. has granted final approval to Microvention Inc., of Aliso Viejo, Calif., for its FRED Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in 18 months – 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.

Jenavalve snares breakthrough device designation for flagship TAVR device

Jenavalve Technologies Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, albeit with a slightly different proposed indication for use compared to currently approved TAVR devices. The news comes at a time when the market for TAVR devices seems to expand every year, but Jenavalve said it will likely file for a humanitarian device exemption in the second half of 2020, indicating that the device won’t be commercially available for at least another year.

Medtronic gets CE mark for DBS system that tracks brain signals, as it undergoes FDA review

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 European Union 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. The implant is slated to be available in Western European countries on Jan. 15. The Percept PC neurostimulator is currently under FDA review.

Lunit secures $25.6M in series C funding for AI-based cancer diagnostics software

HONG KONG – South Korean AI-based med-tech company Lunit Inc., of Seoul, has secured ₩30 billion (US$25.6 million) in series C funding. Founded in 2013, the company has raised $50 million so far. Lunit’s corporate value is estimated to be as much as ₩200 billion as of the fundraising. Lunit is focused on cancer diagnostics and therapeutics using AI software. Its products are being used in multiple hospitals in Mexico, the United Arab Emirates, China, Thailand, Taiwan, and Korea. Its Lunit Insight Cxr, an AI analysis system for chest X-rays won the CE mark in 2019.

Digital health funding landscape still active despite slight dip

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. Even so, Starr noted 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. 

Also in the news

Abionic, Alucent Biomedical, Biodirection, Contextual Genomics, Fusion Genomics, Gyant, Jenavalve, Kdx Diagnostics, Medtronic, Microvention, Pentax Medical, Penumbra, Reflow Medical, Stimgenics, Zipnosis