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stories for medical device companies this week: Masimo reveals FDA warning letter over Pronto 7 monitor; FDA issues new draft guidance on Class III de novos, UDI for small entities; Medicare finalizes coverage for MitraClip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.
Masimo's stock drops 13% as its latest quarter misses analysts' estimates and full-year guidance narrows down.
California device maker Masimo (NSDQ:MASI) got no Wall Street love this week after announcing results for its most recent quarter.
JenaValve taps ex-AtriCure chief David Drachman to be its new CEO.
, Bioject Medical Technologies Inc.
, Echo Therapeutics Inc.
, Hill-Rom Holdings Inc.
, Integrity Applications
, U.S. Veterans Affairs Dept. (VA)
, GI Dynamics
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 (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.
Masimo reveals a probe by federal prosecutors in California over its Pronto and Pronto-7 patient monitoring devices.
Masimo (NSDQ:MASI) said yesterday that federal prosecutors in California this week issued a subpoena over some of its patient monitoring devices.
Here's a look at some of the top personnel stories for medical device companies this week.
Alphatec Holdings Inc.
, Elekta AB
, EndoGastric Solutions Inc.
, Given Imaging
, Hansen Medical Inc.
, Orthofix International
, American Medical Systems Holdings Inc.