Devices

FDA Allows Philips IntelliSite System Marketing

FDA says it is permitting marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. An agency news release says it reviewed the data for the PIPS through the de novo premarket review pathway that is used for devices of a new type with low- to moderate-risk that are not substantially equivalent to an already legally marketed device. FDA evaluated data from a clinical study of about 2,000 surgical pathology cases using tissue from multiple anatomic sites. Results of the study found that diagnoses made based on the PIPS images were comparable to those made using glass slides.

As part of its marketing authorization, FDA established special controls that must be met to assure the digital imaging system’s precision, reliability, and clinical relevance. The agency says that risks associated with using the technology are similar to those in using conventional light microscopy.

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