Devices

1st OTC Continuous Glucose Monitor Cleared

FDA has cleared a Dexcom 510(k) for the company’s Stelo Glucose Biosensor System, which the agency says is the first over-the-counter continuous glucose monitor (CGM). The integrated CGM is intended for “anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels,” an agency release says. “Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.”

The device uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values. FDA says users can wear it for up to 15 days before replacing it with a new sensor. It provides blood glucose measurements and trends every 15 minutes that can be read in the smart app. “Users should not make medical decisions based on the device’s output without talking to their healthcare provider,” the agency notes.

Clearance was based on data from a clinical study that demonstrated the device performed similarly to other CGMs, FDA says, adding that adverse events reported included local infection, skin irritation and pain or discomfort.

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

Read more

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