Devices

Device Cybersecurity Firm Hires Former FDA Reviewer

Medical device cybersecurity consulting firm MedCrypt has hired former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Schwartz as the firm’s new senior director of cybersecurity quality and safety. With six years of device review experience at CDRH and over 20 years of systems engineering experience, Schwartz at MedCrypt will “lead the analysis of cybersecurity designs for medical devices and help medical device manufacturers (MDMs) optimize their cybersecurity framework to meet guidelines set by the FDA,” the company says.

She will also evaluate manufacturer and cybersecurity processes to develop tools that will improve cybersecurity integration into quality management systems and reduce the burden and uncertainty of postmarket management, MedCrypt says.

At FDA, Schwartz approved the software and cybersecurity for the world’s first regulated automated insulin dosing (AID) System and created Class 2 pathways for the three major components of AID systems, MedCrypt says. “Prior to that, Naomi spent 15 years supporting the Department of Defense as a contractor, specializing in radar system requirements and performance analyses, system design, and independent verification and validation.”

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