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for medical device companies this week: Masimo reveals FDA warning letter over Pronto 7 monitor; FDA issues new draft guidance on Class III de novos, UDI for small entities; Medicare finalizes coverage for MitraClip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

Abbott inks $20M Pentagon deal for brain injury device

August 15, 2014 by Brad Perriello

The U.S. Defense Dept. inks a $20 million contract with Abbott to develop biomarkers and a diagnostic test to detect traumatic brain injury in military personnel.

Abbott inks $20M Pentagon deal for brain injury device

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Medicare finalizes coverage for MitraClip

August 11, 2014 by Arezu Sarvestani

Medicare regulators agree to reimburse transcatheter mitral valve repair devices, a major win for Abbott and its market-leading MitraClip implant.

Medicare finalizes coverage for MitraClip

The Centers for Medicare & Medicaid Services issued a final coverage decision for transcatheter mitral valve replacement devices, a decision that currently only affects Abbott's (NYSE:ABT) MitraClip implant.

Abbott's MitraClip, St. Jude's CardioMEMS land new Medicare coverage

August 6, 2014 by Arezu Sarvestani

Medicare regulators finalize new reimbursement coverage for Abbott's MitraClip heart valve device and St. Jude Medical's CardioMEMs heart failure monitoring system.

Abbott's MitraClip, St. Jude's CardioMEMS land new Medicare coverage

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Medtech's top stent-makers land SharedClarity contracts

July 29, 2014 by Arezu Sarvestani

Healthcare-provider alliance SharedClarity signs some of medtech's biggest firms to land specialized pricing for peripheral stents.

Medtech's top stent-makers land SharedClarity contracts

Four of medtech's biggest firms agreed to offer peripheral stents at specialized prices to members of SharedClarity, an organization formed through the alliance of some of the country's largest health insurance and care providers.

Abbott CEO chides critics of corporate inversions | Medtech Wall Street news for the week of July 21, 2014

July 24, 2014 by MassDevice

Here's a look at some of the top Wall Street stories for medical device companies this week: Abbott CEO defends inversions amid corporate exodus furor; Medtronic fights tax dodging rhetoric in Covidien merger; Allergan cuts 1,500 jobs, faces SEC complaint; A countdown to failure for Valeant's hostile $53B Allergan takeover; GE Healthcare idles for another quarter

Abbott CEO defends inversions amid corporate exodus furor

July 18, 2014 by Arezu Sarvestani

Abbott CEO defends inversions amid corporate exodus furor

JNJ looks to bolster "subscale" cardiovascular business | The week in medtech M&A

July 23, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Johnson & Johnson eyes acquisitions in cardiovascular, elsewhere; Abbott CEO defends inversions amid corporate exodus furor; Medtronic fights tax dodging rhetoric in Covidien merger; Could Medtronic-Covidien deal get caught in anti-inversion legislation?; Siemens sells clinical microbiology biz to Beckman Coulter

Johnson & Johnson eyes acquisitions in cardiovascular, elsewhere

July 16, 2014 by Brad Perriello

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