The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
Several U.S. government agencies have been involved in the enforcement action directed toward Medifirst Solutions Inc., of Freehold, N.J., including the Department of Justice, but the Securities and Exchange Commission (SEC) has had its say as well. The SEC recently announced that a final consent judgment has been entered against a former Medifirst stock promoter, although there is still no word as to the fate of the company’s former CEO.
The U.S. FDA has granted Alpheus Medical Inc. orphan drug and fast track designations for a therapeutic platform that could improve outcomes for patients suffering from recurrent glioblastoma (GBM), the most common primary brain cancer and among the hardest to treat.
Citing “the current political conditions,” Russian Minister of Health Mikhail Murashko laid out ways for Russia to strengthen its international role in the health care sector, including the development of innovative radiopharmaceuticals. Other promising opportunities involve the improvement of drug provision and an increase in the number of foreign students in Russian medical universities, Murashko said at a July 19 meeting with medical, educational and scientific institutions in Russia.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irthythm, Verily.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Catheter Precision, Hanger, One Health Solution, Ra Medical, Spine Innovations, Spineway, Verustat.
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