Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics.
TORONTO – Seven years after setting up shop in downtown Toronto, high resolution, surgical imaging med-tech company Perimeter Medical Imaging Inc. (PMI) is still wrestling with a statistical heartbreaker: 1 in 4 patients told to return for a second surgery to remove cancerous breast tissue after the first surgery failed to get it all. Now PMI has said it can cut that number down dramatically thanks to a $7.44 million investment from the Austin, Texas-based Cancer Prevention and Research Institute of Texas (CPRIT) to identify wayward breast cancer cells using artificial intelligence technology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Feedback, Gelesis, Philips, Zoll.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airos Medical, GE Healthcare, Gynesonics, Quest Diagnostics.
KARACHI, Pakistan – Beyond stepping up manufacturing of the medical devices it needs to fight COVID-19, Pakistan is using technology platforms to reach out to a large diaspora for help. The country is taking steps to leverage limited resources through a more comprehensive system of telehealth applications that allow for faster self-diagnosis and make it possible to tap into the expertise of Pakistani doctors.
Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona COVID-19 antibody testing platform, combining antibody testing with a blockchain-enabled smartphone app to increase predictability and traceability of potential outbreaks.
Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor BX100, has received FDA clearance and a CE mark and is intended for use in lower acuity hospital care.
Although many companies have experienced struggles during the COVID-19 pandemic, Brisbane, Australia, and Carlsbad, Calif.-based Impedimed Ltd. has seen success with Sozo, the company’s digital health platform. Indeed, the company has as one of its priorities helping patients with lymphedema with the platform, which is a noninvasive bioimpedance spectroscopy device.
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