Category: MasimoSyndicate content

Medical company may be falling short of its patient-safety ideals

October 6, 2014 by MassDevice

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.

Medical company may be falling short of its patient-safety ideals

(Courtesy of the Patient Safety Movement Foundation)

by Marshall Allen and Annie Waldman, ProPublica

This story was co-published with NPR's Shots blog.

ReGen Biologics wins round in battle with the FDA over its MenaFlex knee implant | Medtech legal news for the week of October 6, 2014

October 6, 2014 by MassDevice

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

Appeals court vacates FDA's rescission of ReGen's MenaFlex implant

September 29, 2014 by Brad Perriello

Masimo wins $467m verdict in patent spat with Philips

October 2, 2014 by Alex Soule

A jury delivers a $467 million verdict for Masimo in a patent infringement spat with Royal Philips over pulse oximetry technology.

Masimo wins $467m verdict in patent spat with Philips

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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.

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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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