Devices

De Novo OK for Google Phone Thermometer

FDA has granted a de novo marketing authorization to Google and its new body temperature app on its latest Pixel 8 Pro smart phone. The app is part of the company’s January Pixel feature drop and it allows users to quickly scan a person’s forehead with the phone to measure the body temperature. “In clinical trials, our software algorithm was able to calculate body temperature in the range of 96.9°F - 104°F (36.1°C - 40°C) to within 0.3°C when compared with an FDA-cleared temporal artery thermometer,” the company says.

“Bodies emit infrared radiation — or, simply put, heat,” Google says. “The Pixel 8 Pro team added an infrared sensor to the phone next to the rear camera, which at launch was used to power the object temperature feature and now powers the body temperature feature as well. Measuring body temperature on the Pixel 8 Pro is simple: Just point the rear camera at the forehead and sweep across. The Pixel 8 Pro body temperature app accurately measures your temperature by scanning the temporal artery, unlike less accurate forehead thermometers that are pointed at the center of the forehead. The data from the infrared sensor is passed to an algorithm to calculate the temperature that will be displayed on your device, powered by the Tensor G3 chip.”

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