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MDT's Ev3 pays $1.3m in whistleblower suit | Medtech legal news for the week of February 16, 2015

February 16, 2015 by MassDevice

Here's a look at some of the top legal news stories for medical device companies this week: Medtronic's new Ev3 unit pays $1.3m in whistleblower suit; Medtronic settles another whistleblower suit for $2.8m; Ex-NFL great Gault must face SEC fraud charges; Appeals court upholds Abiomed win in shareholders lawsuit; Pelvic mesh lawsuits: Boston Scientific wants 700 Philly cases sent to federal court

Medtronic's new Ev3 unit pays $1.3m in whistleblower suit

February 6, 2015 by Brad Perriello

Appeals court upholds Abiomed win in shareholders lawsuit

February 9, 2015 by Brad Perriello

A federal appeals court upholds Abiomed's win in a shareholders lawsuit accusing the company of inflating its stock price with rosy predictions for its flagship Impella 2.5 heart pump.

Appeals court upholds Abiomed win in shareholders lawsuit

Abiomed (NSDQ:ABMD) logged another win in a shareholders lawsuit accusing it and its management of misleading investors over the prospects for its flagship Impella 2.5 heart pump.

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Asante Solutions sets terms for pending IPO | Medtech Wall Street news for the week of January 26, 2015

January 29, 2015 by MassDevice

Here's a look at some of the top Wall Street stories for medical device companies this week: Asante Solutions sets IPO terms; Stryker CEO Lobo: M&A is our top priority for cash; Abiomed surges on Q3 numbers, FDA nod; Credit agencies lower Medtronic's rating post-Covidien merger

Diabetes: Asante Solutions sets IPO terms

January 23, 2015 by Brad Perriello

Abiomed surges on Q3 numbers, FDA nod

January 28, 2015 by Brad Perriello

Abiomed shares surge to an all-time high after the heart pump maker crushes expectations with its fiscal 3rd-quarter results and raises its outlook for the rest of fiscal 2015.

Abiomed surges on Q3 numbers, FDA nod

Abiomed (NSDQ:ABMD) shares surged to an all-time high today after the heart pump maker crushed expectations for its fiscal 3rd quarter and raised its outlook on the rest of the year.

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FDA approves Abiomed's Impella RP

January 27, 2015 by Brad Perriello

Abiomed wins a humanitarian device exemption for its Impella RP

FDA approves Abiomed's Impella RP

Abiomed (NSDQ:ABMD) today said the FDA approved a humanitarian device exemption for its Impella RP heart pump, calling the device the 1st FDA-approved percutaneous, single-access pump for supporting the heart's right ventricle.

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FDA warning letter to Cook Medical finds problems during inspections of plant | Regulatory news for the week of November 3, 2014

November 4, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: FDA warns Cook Medical on 'nonconformance' issues; Abiomed jumps on FDA deal for Impella indication; Hansen Medical launches 3rd-gen Sensei surgical robot; Medtronic wins EU nod for Resolute Onyx stent

FDA warns Cook Medical on 'nonconformance' issues

October 28, 2014 by Brad Perriello

Abiomed jumps on FDA deal for Impella indication

October 30, 2014 by Brad Perriello

Abiomed says it's come to an agreement with the FDA on an indication for its flagship Impella 2.5 heart pump, and now expects to win pre-market approval early next year without a hearing before an FDA advisory panel.

Abiomed jumps on deal with FDA

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