Category: MasimoSyndicate content

Masimo takes new infant monitors to Europe, Japan

August 28, 2014 by Arezu Sarvestani

Masimo wins clearance in Japan and approval in Europe for its rainbow DCI-mini non-invasive hemoglobin monitor for infants and small kids.

Masimo takes new pediatric monitors to Europe, Japan

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.

Press Release: Masimo announces CE Mark and limited market release of rainbow DCI-mini

August 28, 2014 by MassDevice

First noninvasive total haemoglobin (SpHb) spot-check sensor for infants and small children.

Press Release: Masimo announces CE Mark and limited market release of rainbow DCI-mini

Masimo receives warning letter from FDA over its Pronto 7 pulse oximeters | Regulatory news for the week of August 18, 2014

August 19, 2014 by MassDevice

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stories for medical device companies this week: Masimo reveals FDA warning letter over Pronto 7 monitor; FDA issues new draft guidance on Class III de novos, UDI for small entities; Medicare finalizes coverage for MitraClip

Masimo reveals FDA warning letter over Pronto 7 monitor

August 15, 2014 by Brad Perriello

Masimo reveals FDA warning letter over Pronto 7 monitor

August 15, 2014 by Brad Perriello

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.

FDA warns Masimo on inadequate complaint reviews

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.

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Masimo sinks as Q2 misses the mark

August 8, 2014 by Arezu Sarvestani

Masimo's stock drops 13% as its latest quarter misses analysts' estimates and full-year guidance narrows down.

Masimo sinks as Q2 misses the mark

California device maker Masimo (NSDQ:MASI) got no Wall Street love this week after announcing results for its most recent quarter.

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Masimo escapes blood testing patent lawsuit

July 1, 2014 by Brad Perriello

A California federal judge dismisses a blood testing patent infringement lawsuit brought against Masimo after finding that the plaintiff, Dominion Assets, didn't own the patents when it filed the lawsuit.

Masimo escapes blood testing patent lawsuit

Masimo (NSDQ:MASI) dodged a patent infringement lawsuit last week after a federal judge in California found that the plaintiff, Dominion Assets, didn't actually own the patents when filed the suit.

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