Devices

FDA Backing Off Some Ophthalmic Device Enforcement

FDA says that for the duration of the coronavirus public health emergency in the U.S. it will not object to limited modifications to the indications, functionality, hardware, and/or software of 510(k)-cleared devices for remote assessment and monitoring of ophthalmic parameters. An immediately-in-effect guidance says that in the context of the public health emergency, expanding the capability of remote ophthalmic assessment and monitoring devices may help facilitate patient care while reducing patient and healthcare provider contact and risk of exposure to SARS-CoV-2.

The document says the enforcement discretion applies to specific devices named in the guidance that have the potential to be connected to a wireless network through Bluetooth, Wi-Fi, or cellular connection to transmit a patient’s ophthalmic parameters directly to their eye care provider or other monitoring entity. “Some of these devices also have the potential to apply algorithms to transform a patient’s ophthalmic parameters into a novel index or alarm that may aid an eye care provider in the diagnosis of a particular condition or disease state/severity or be used in the context of a telemedicine visit, with the patient at home, allowing the eye care provider to assess specific ophthalmic parameters remotely,” the guidance 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