Devices

At-home AI Skin Cancer Screener Being Studied

Sklip Inc. says it has received IRB approval to clinically test its Sklip artificial intelligence (AI) skin cancer triage system with patients in home settings. The device, which has gained a breakthrough designation from FDA, is considered a “software as a medical device” tool that uses “proprietary artificial intelligence technology to triage skin cancers using digital dermoscopy images,” according to the company. The company says the data from the home-based study will be used to support a planned 510(k), adding that the home-based digital health tool has the “potential to reduce wait times to see a dermatologist from an average of 6 months to 10 days.”

Sklip says it has made it simple for health professional and patient users to acquire the images on their smartphones when using its Sklip dermatoscope attachment. The attachment does not require an adapter and when aligned with a smartphone rear-facing camera, allows the user to take high-definition medical grade images of self-selected moles of concern. “The use of Sklip System AI can identify early signs of skin cancer with an accuracy above 95%,” it says.

The company says that making Sklip System Artificial Intelligence available in American homes can potentially improve earlier triage and detection of skin cancers. “Early identification of melanoma skin cancer before it becomes invasive can increase five-year survival rates from 24% to 99%,” it 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