News In Brief
This article was originally published in The Gray Sheet
Edwards Lifesciences buys BMEYE for $42 mil. Sapien valve sales in Q3 fall below firm’s expectations. Hospira draws FDA warning letter. More news briefs.
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ClearSight is intended to reduce the risk of post-surgical complications by non-invasively monitoring blood volume and flow based on information gathered by a small finger cuff with an infrared sensor.
The warning letters cite quality system regulation violations related to the firm’s infusion pumps, including inadequate corrective and preventive actions related to complaints of over-infusion and device bladder ruptures.
OIG announces investigation of Medicare’s competitive bidding program in four states and, separately, finds inappropriate and questionable CMS billing for diabetes test strips. AHRQ seeks information about imaging tests for diagnosis and staging of pancreatic cancer. More reimbursement news.