Easyendo Surgical Inc. has won the South Korean Ministry of Food and Drug Safety’s (MFDS) latest breakthrough device designation for its robotized ureteroscope. The device, currently known as Easyuretero, is the first of its type to be developed in South Korea. The next goal for Easyendo will be regulatory approval, said the MFDS. Daejeon, South Korea-based Easyendo is already working towards winning that approval. “We are now preparing to start clinical trials in South Korea, and discussing the start date and scope of the trials with MFDS,” an Easyendo spokesperson told BioWorld.
Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives an influx of investment, companies will be in strong positions to expand their portfolios. So, with 2022 around the corner – what are the investment trends to watch?
Far from the Groundhog Day spectacle of amyloid-targeting antibodies that do little to nothing for patients in trial after trial, researchers have reported success in reducing the risk of Alzheimer’s disease (AD) in unexpected ways. Researchers at the Cleveland Clinic Foundation have discovered that a Viagra prescription was associated with a roughly 70% reduced risk of being diagnosed with AD. And investigators from the University of Washington reported that in the prospective Adult Changes in Thought study, a long-term study into risk and protective factors for dementia, persons who underwent cataract surgery reduced their risk of AD by 30%, an effect that lasted for 10 years after surgery.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amra Medical, Audere, Cosara, Foldax, Linus Biotechnology, Medtronic.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blink, Bluecore, Guebert, Janssen, Juama, Nanosonics, Persephone, Persown, Powered by MRP, Shields Health Care, Sourcemark, Vizient.
Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).
Israeli startup Ophthalmic Sciences Ltd. is targeting 2023 for regulatory clearance of its artificial intelligence (AI)-based contactless intraocular pressure (IOP) measuring device, IO Perfect. The technology, which combines AI visual analysis in a virtual reality headset, enables remote monitoring of glaucoma. The device is designed to be used at home, in eye clinics, emergency room departments, pharmacies and primary physician settings.
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