Devices

FDA OKs Abbott’s FreeStyle Continuous Glucose Monitor

FDA has approved an Abbott PMA for the FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals to use with their diabetic patients. The device is intended to provide healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), “giving a more simplified and clear overview of not only glucose levels, but also patterns and trends within those levels,” the company says.

Libre Pro tem is applied to patients by healthcare professionals in a clinic setting. A round sensor is applied on the back of a patient’s upper arm. “The water-resistant and disposable sensor is held in place with a self-adhesive pad and remains on the back of the arm for up to 14 days, requiring no patient interaction with the device or the need for the patient to draw blood via a fingerstick to calibrate the sensor,” Abbott says. “The sensor continuously measures glucose in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin. It records glucose levels every 15 minutes, capturing up to 1,340 glucose results for up to 14 days, giving the treating doctor comprehensive data for a complete glycemic profile of their patient.”

After 14 days, the patient returns to the doctor’s office, where the FreeStyle Libre Pro reader is used to scan the sensor and download the glucose results that are stored in it. The data are used to prepare an AGP, a report developed by the International Diabetes Center that is presented in a single, user-friendly, visual chart providing healthcare professionals a complete glycemic view of their patients’ glucose trends, Abbott says.

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