Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.
Current Health Ltd. closed an oversubscribed series B financing, securing $43 million in a round led by Northpond Ventures. The Edinburgh, U.K.-based company will use the funds to scale up its remote care management platform. Other participants included Lrvhealth, OSF Healthcare, Section 32, Elements Health Ventures, as well as existing investors. With this latest infusion, Current Health has raised a total of $66 million to date.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Ambu, Getinge, Impedimed, Nēsos, Novocure, Orthofix, Soundbite.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Better Therapeutics, Diacarta, Elixir Medical, Solace Therapeutics.
Keeping you up to date on recent developments in diagnostics, including: AI-based model to triage brain MRIs; Tiny light probes enhance brain imaging; Predicting natural menopause age.
As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.
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