Category: Abiomed Inc.Syndicate content

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.

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.

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

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Medtronic taps Brigham & Women's prez Nabel for board | Personnel Moves

September 18, 2014 by Brad Perriello

Medtronic taps Dr. Elizabeth Nabel, president of Brigham & Women's Faulkner Hospital in Boston, for a seat on its board of directors.

Medtronic taps Brigham & Women's prez Nabel for board | Personnel Moves

Abiomed touts survival rates for its Impella right-side heart pump | TCT 2014 Roundup

September 17, 2014 by Arezu Sarvestani

Abiomed unveils new results from an IDE study of its Impella Right Percutaneous heart pump, reporting 73% survival in patients with right ventricular failure.

TCT 2014 Roundup

Abiomed (NSDQ:ABMD) got some Wall Street love today after releasing positive outcomes from a clinical trial of its minimally invasive Impella Right Percutaneous heart pump.

Researchers reported an overall 73% 30-day survival rate in the small study of patients with right ventricular heart failure, according to data Abiomed released during the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.