Masimo Corporation’s chief executive is a leading voice in the movement to reduce medical errors, but the Food and Drug Administration says his company isn’t properly investigating complaints.
(Courtesy of the Patient Safety Movement Foundation)
by Marshall Allen and Annie Waldman, ProPublica
This story was co-published with NPR's Shots blog.
Here's a look at some of the top legal news stories for medical device companies this week: Appeals court vacates FDA's rescission of ReGen's MenaFlex implant; Masimo wins $467m verdict in patent spat with Philips; Endo reaches deal to end remaining U.S. lawsuits over mesh; Judge halves $74m pelvic mesh verdict against Boston Scientific; Judge tosses FDA whistleblowers lawsuit
A jury delivers a $467 million verdict for Masimo in a patent infringement spat with Royal Philips over pulse oximetry technology.
Masimo wins clearance in Japan and approval in Europe for its rainbow DCI-mini non-invasive hemoglobin monitor for infants and small kids.
California-based medical device maker Masimo (NSDQ:MASI) is planning a limited market launch of its 1st-of-its kind hemoglobin monitor for infants and small children after winning approval from regulators in Japan and Europe.
First noninvasive total haemoglobin (SpHb) spot-check sensor for infants and small children.
Here's a look at some of the top regulatory stories for medical device companies this week: Masimo reveals FDA warning letter over Pronto 7 monitor; FDA issues new draft guidance on Class III de novos, UDI for small entities; Medicare finalizes coverage for MitraClip
The FDA sends a warning letter to Masimo, saying the company doesn't have procedures in place to adequately investigate and document device failure complaints for its Pronto 7 pulse oximeter.
Masimo (NSDQ:MASI) said it received a warning letter yesterday from the FDA over its procedures for reporting and investigating failure complaints for its Pronto 7 pulse oximeters.