Drugs

DermaSensor AI Skin Cancer Detector Cleared

FDA has granted a marketing authorization for DermaSensor's real-time, skin cancer evaluation system. The device uses the company’s AI-powered spectroscopy technology to “non-invasively evaluate cellular and subcellular characteristics of a lesion in question for skin cancer,” the company says. “The wireless, handheld device then provides an immediate, objective result using an FDA-cleared algorithm.”

The prescription device is indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and over to assist healthcare providers in determining whether to refer a patient to a dermatologist, the agemcy says. "The device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists," it says. "The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm a diagnosis of skin cancer." The agency also says it is requiring that DermaSensor conduct additional post-market clinical validation performance testing on the device in patients from demographic groups representative of the U.S. population.

The clearance relied on a pivotal study of over 1,000 patients, led by the Mayo Clinic across 22 study centers to validate device performance. It showed that the device had a sensitivity of 96% across all 224 skin cancers, according to DermaSensor. “A negative result had a 97% chance of being benign for all skin cancers,” it says. “In a companion clinical utility study with 108 physicians, the DermaSensor device was found to decrease the number of missed skin cancers by half (from 18% to only 9%), increasing the physicians’ accuracy and confidence in assessing cancerous lesions.”

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