Sometimes little things can create big problems, which seems to be the case with the recall of the power unit used with the Abbott Heartmate 3 left ventricular assist device (LVAD). According to the FDA recall announcement, the power cords used with the power supply might not stay fixed in place, which would leave the power supply with 15 minutes of backup battery runtime before depletion.
The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerlin Medical, Medtronic, Myriad, Tensive, Terumo.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearpoint Neuro, Ibex, Roche.
If a cancer patient has bone metastases, they will frequently have anemia as well. Given that the bone marrow is the site of blood cell formation, this observation is perhaps not unexpected. But its molecular underpinnings had been unclear to date. Now, researchers at Princeton University and the Rutgers Cancer Institute of New Jersey have identified a specialized group of iron-transporting macrophages in the metastasis-anemia link.
You can’t fault Alcon AG’s focus. In the midst of an extended series of acquisitions, the company has a clear vision of creating a deep ophthalmic treatment pipeline – and diagnostics fall outside that line of sight.
The U.S. Department of Health and Human Services (HHS) reported Sept. 3 that it will engage in “active enforcement” of information blocking rules, each violation of which carries a fine that may reach seven figures.
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