A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda. Read More
Surgical care startup Medivis Inc. tallied $20 million in a series A financing led by Thrive Capital. The funds will be used to advance its 3D holographic clinical visualization system. Initialized Capital and Mayo Clinic also participated in the round, along with investors Bob Iger, Kevin Durant, Robert Spetzler, Hugo Barra and Coalition Operators. With the funding from the series A, Medivis has raised a total of roughly $25 million to date. Read More
Aptamer Group plc and Neuro-Bio Ltd. have developed Optimer binders which could enable the creation of a lateral flow test for the early diagnosis of Alzheimer’s disease. Aim-listed Aptamer saw its share price soar on the news as early detection of Alzheimer could bring substantial benefits to patients, caregivers and health care systems and there is currently a lack of tests available for early stage diagnosis of the disease. Read More
Cala Health Inc. expanded availability of its next-generation bioelectronic Kiq device for relief of action tremors to include individuals with Parkinson’s disease as well as essential tremor. The broad commercial launch of the FDA-cleared wrist-worn device will enable more patients to use the transcutaneous afferent patterned stimulation (TAPS) therapy, which studies show reduces tremors and improves performance of activities of daily living. Read More
The French government is officially launching a major national program for digital health. This priority research program and equipment (PEPR) in digital health is being piloted by two major government research bodies, the National Institute for Health and Medical Research (INSERM) and the National Institute for Research in Digital Science and Technology (INRIA). It has a budget of $65 million over seven years Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Core Sound, Cytosorbents, Dignitana, Histoindex, Ion Beam, Juno Diagnostics, Nordic Bioscience, Raysearch, Shinva, Walgreens. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cutera, Vielight. Read More
