FDA Policy/General

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Dextera Surgical has agreed to sell all assets to Aesculap, a B. Braun company. The transaction includes the MicroCutter 5/80 Stapler, PAS-Port and C-Port automated anastomosis system cardiac surgery products, and the firm’s technology portfolio. In 12/2017, Dextera filed a voluntary Chapter 11 bankruptcy petition.

Varian Medical Systems has acquired privately-held Mobius Medical Systems, a provider of radiation oncology quality assurance software. The Mobius QA software is in use at over 1,000 sites worldwide.

Teva Pharmaceutical Industries has completed the sale to CVC Capital Partners of a portfolio of products within its global women’s health business across contraception, fertility, menopause and osteoporosis for $703 million. The portfolio, which is marketed and sold outside of the U.S., includes Ovaleap, Zoely, Seasonique, Colpotrophine, Actonel and additional products. The business will be known as Theramex.

Quest Diagnostics has completed its acquisition of Mobile Medical Examination Service, a national provider of home-based health risk assessments and related services. The transaction is intended to strengthen Quest’s mobile provider capabilities and population health management solutions for health plans.

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