Devices

FDA Says Digital Health Policies Help Covid-19 Solutions

FDA says that digital health technologies can provide tools for public health officials and the public to use in managing the Covid-19 response by helping public health officials reach and communicate with a vast number of people more quickly, efficiently, and effectively. An online post says the agency does not consider most apps and software systems for public health surveillance and communication to be medical devices that it regulates.

“These are mobile apps or solutions that are intended for use by public health officials at the CDC and at state and local health departments to improve communication between public health officials and members of the public, including by people who may have been exposed to a disease of interest to public health officials such as Covid-19,” the statement says. “These solutions may help people document the presence or absence of commonly understood symptoms such as fever and shortness of breath in themselves or in others with whom they have had close contact. These solutions may also help people support public health officials’ efforts to retrace locations visited and people with whom they have had close contact.”

The notice says FDA has clarified its risk-based approach to regulating digital health products through a 9/2019 guidance on device software functions and mobile medical applications.

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