This article was originally published in The Gray Sheet
Enrolls 24 patients in a six-month clinical study of its PHD personal hemodialysis system to support a future 510(k) submission to FDA. The three-phase trial is being conducted at dialysis clinics located in Washington, Missouri and Mississippi
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Firm raises $11.8 mil. in a private placement of 1.5 mil. shares to institutional investors. Lincolnshire, Illinois-based Aksys is conducting clinical trials of its PHD personal hemodialysis system and expects to submit a 510(k) by the end of October (1"The Gray Sheet" Jan. 10, In Brief). Proceeds will support pre-commercialization activities, including a planned ramp-up in sales staff and manufacturing. U.S. Bancorp Piper Jaffray was placement agent for the financing
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.