Blockage Leads to Resuscitator Recall
Teleflex Medical has recalled its Hudson RCI Lifesaver single-patient use resuscitator after reports of oxygen intake ports becoming blocked, preventing the delivery of breathing support. The disposable medical device is intended to provide temporary breathing support for patients experiencing acute ventilatory failure. The company initiated the recall May 15 for products manufactured and distributed between June 2014 and April 2015. The FDA has deemed it a Class I recall. Teleflex says it has not received any reports of injuries or deaths related to the recall.
Allergan to Buy Oculeve
Allergan has signed an agreement to acquire South San Francisco, Calif.-based Oculeve for $125 million upfront in an all-cash deal, plus commercialization milestone payments related to the development program of OD-01. Oculeve’s OD-01 is a nasal neurostimulation device that boosts tear production in patients with dry eye disease. The company has completed four clinical studies of the device in more than 200 patients. Allergan plans to conduct two more pivotal trials prior to FDA submission, which is expected next year. Allergan anticipates the deal will close the third quarter of the year.
SculpSure Snags Expanded Indication
Cynosure’s SculpSure lipolysis laser treatment has won an expanded FDA indication for noninvasive fat reduction in the abdomen. The hands-free device uses a laser to treat the desired area in about 25 minutes, and patients can achieve results without downtime or surgery, the company says. The technology is expected to be launched in the U.S. in the second half of the year. In May, the FDA cleared the laser treatment for noninvasive lipolysis of the flanks.
FDA Green Lights Herpes Test
Theranos has gained FDA 510(k) clearance for its herpes simplex 1 virus IgG test system. The test uses finger stick and venous blood testing technology, the Palo Alto, Calif.-based company says. Unlike conventional tests that are cleared for venous samples, the system can be used for venous, venous plasma, capillary plasma and capillary whole blood samples, the consumer healthcare technology company claims. This is the company’s first FDA clearance.
Quantidex Pan Cancer Kit Launched
Austin, Texas-based Asuragen has launched its Quantidex pan cancer kit, a next-generation sequencing oncology panel that classifies mutations on 21 genes associated with different cancers. The assay, which provides analysis of both formalin-fixed paraffin embedded and fine-needle aspiration tissues, features sample multiplexing, high analytical sensitivity and the ability to profile a large number of biomarkers in a single test, according to the company. The Cancer Prevention and Research Institute of Texas helped fund the kit’s development. The assay is intended for research purposes only.