Devices

Oracle Technology Guru Named FDA Digital Health Director

After 11 years at cloud and computer tech company Oracle, Troy Tazbaz has joined FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left the agency last May to work for Google Health and its parent company Alphabet as senior director for global health strategy and regulatory (see earlier story).

Tazbaz announced his new job on LinkedIn 1/30 and said he will be “responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. And we enable that vision through technology evaluation, policy development, and strategic partnerships.” At Oracle, Tazbaz most recently served as Industries Business Unit Strategy & Operations senior vice president. From 2017-2019 he was Corporate Operations vice president and from 2011-2017 he was Oracle Cloud Data Center senior director.

Asked to comment on Tazbaz’s hiring, FDA provided this statement to FDA Webview: “As digital health technologies play an increasing and significant role in health care, Troy’s wealth of technology industry leadership and management experience will further support the agency’s vision for digital health and build upon years of progress of the program. In his role, Troy will lead the Digital Health Center of Excellence in its next phase, which is focused on continued growth and improvement of building and sustaining capacity for strategic partnerships, innovating regulatory frameworks for digital health and continued harmonization with other regulators.”

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