Devices

Sky Medical New Geko Device Cleared

FDA has cleared a Sky Medical Technology 510(k) for its new (W3) geko device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency or ischemia. The (W3) device follows the company’s 2021 FDA-cleared (W2) geko device, which was also authorized for venous insufficiency or ischemia, according to the company. The new (W3) geko “brings with it the added benefit of a third electrode, enabling greater patient reach (nerve stimulation), patient comfort and better patient outcomes – and an increase to two 12 hour therapeutic doses, where previously the (W2) device provided two six hour doses,” Sky Medical says.

The company describes the geko as a wristwatch-sized wearable therapy device that is worn at the knee. The disposable device “gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf, at a rate equal to 60% of walking without a patient having to move,” it says. “The device operates without external pressure to the leg and allows complete mobility.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome