FDA Policy/General

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SleepQuest, a provider of care management services for obstructive sleep apnea, has acquired Grove Medical Equipment based in Alameda, CA. SleepQuest closed the transaction 6/30 and began serving the former customers of Grove Medical 7/1.

ThermoGenesis has entered into an asset acquisition agreement with SynGen, a privately-held Sacramento, CA-based technology company active in the cellular processing field. Under the agreement, ThermoGenesis acquired substantially all of SynGen’s operating assets, including its proprietary cell processing platform technology. In exchange, ThermoGenesis granted SynGen 20% of its common stock and paid a one-time cash payment of $1 million.

Entellus Medical has entered into a definitive agreement to acquire Spirox, a privately-held medical technology company that develops, manufactures and markets the Latera Absorbable Nasal Implant for treating nasal airway obstruction. Under the agreement, Entellus will acquire Spirox for $25 million in cash and 3.4 million shares of Entellus common stock, plus additional contingent payments over four years based on revenue growth.

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