Devices

FDA Taps Industry Vet as Device Evaluation Chief

FDA has appointed former Olympus Medical Systems chief medical officer Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing William Maisel who retired earlier this year and is now senior medical officer at robotics company Intuitive Surgical. During his time at Olympus, Segan likely dealt with significant GMP issues that were raised during an FDA inspection at the firm’s Tokyo facility. In a 3/15/23 Warning Letter, an 11/2022 inspection faulted Olympus for failing to adequately establish and maintain procedures for implementing corrective and preventive actions. The company also failed to ensure that when changes or process deviations occur, they should be reviewed and evaluated or revalidated where appropriate.

Earlier the same year, FDA inspections found GMP deficiencies at two other Olympus facilities in Japan (see story) that led to separate Warning Letters. At the time, then-CDRH director Jeff Shuren noted in a statement that the two Warning Letters are the “most recent in the history of CDRH’s compliance actions against Olympus related to MDR and quality system requirements. CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes. However, as described in the recent Warning Letters, Olympus is not in compliance with MDR reporting and quality system requirements.”

Prior to working at Olympus, Segan served for six years as chief medical officer at Johnson & Johnson’s Depuy Synthes device unit, and before that he was the chief medical officer for six years at Medronic’s Covidien Surgical Solutions.

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