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%.
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.
Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines recommended for approval by regulators from Europe’s Committee for Medicinal Products for Human Use (CHMP) in a busy sitting.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Incannex, Junshi, Karyopharm, NLS, Obsidian, Olema, Pliant, Recursion, Sandoz, Sangamo.
Smiths Medical Inc., of Minneapolis, has undertaken a recall of its Medfusion 3500 and 4000 series of syringe infusion pumps because of software issues that could lead to over- or under-infusion of the drug. The U.S. FDA said the devices swept up in this class I recall are associated with seven serious injuries and one fatality, although the manufacturer indicated that a software update is in the works.
Data privacy laws are springing up more regularly in the past couple of years, including in several U.S. states, but Congress seems inclined to step in to avoid a patchwork of regulations across the 50 states. The House Energy and Commerce Committee gave a ringing endorsement of new legislation via a 53-2 vote for H.R. 8152, a bill that would largely preempt the growing list of state privacy laws, but makers of health apps and other digital products might eventually be subject to private litigation under the terms of the bill.
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.
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