News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Pharmaceuticals buys Oceana. Stryker cuts costs. Senate passes device center funding bill. More news briefs.
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People In Brief
Tactile Systems Technology appoints former Hill Rom CEO Peter S. Soderberg to be chairman. More people briefs.
New Products In Brief
Recent 510(k) clearances include Andrew Technologies’ HydraSolve lipoplasty system for fat reduction; Insulet’s next-generation, tubeless OmniPod insulin pump; and PhysioSonics’ Presto 1000 cerebral blood flow monitor.
'Not-Approvable' Letter Fits Trend For Optical Cancer Detectors, Guided Therapeutics Says
The company's response to an FDA not-approvable letter for its LuViva cervical cancer scanner will be guided by the experiences of other light-based cancer detector developers that encountered the same initial setback. The firm's likely next step: petitioning FDA for an advisory panel meeting.