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EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer

September 10, 2019 By Sean Whooley Leave a Comment

EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure. Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs […]

Filed Under: Cardiac Implants, Clinical Trials, Featured, Food & Drug Administration (FDA), Implants, News Well, Regulatory/Compliance, Structural Heart, Surgical Tagged With: EBR Systems Inc., FDA

EBR Systems adds $30m, ex-Ceterix CEO McCutcheon

August 27, 2019 By Brad Perriello Leave a Comment

EBR Systems said today that it raised a $30 million funding round and tapped ex-Ceterix Orthopaedics CEO John McCutcheon to be its new chief executive. The Sunnyvale, Calif.-based company is developing the Wise wireless pacemaker, designed to use a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle to […]

Filed Under: Cardiovascular, Featured, Funding Roundup, Wall Street Beat Tagged With: Cardiac Rhythm Management, EBR Systems Inc., Personnel Moves

EBR Systems launches trial for wireless pacer

March 8, 2018 By Brad Perriello Leave a Comment

EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval. Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right […]

Filed Under: Cardiovascular, Clinical Trials Tagged With: Cardiac Rhythm Management, EBR Systems Inc.

These medtech companies raised the most VC last year

January 19, 2018 By Danielle Kirsh Leave a Comment

Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]

Filed Under: Cardiovascular, Digital Health, Funding Roundup, Hospital Care, Implants Tagged With: Auris Surgical Robotics, Cereve, EarLens, Ebb Therapeutics, EBR Systems Inc., Epix Therapeutics (formerly Advanced Cardiac Therapeutics), Fractyl Laboratories, immusant, MedTech, Moximed, NeuroPace, Outset Medical, Pulmonx, Respicardia, rxsight, Silk Road Medical Inc., venture capital, VertiFlex Inc., Xenex

EBR Systems pulls in $50m for wireless pacer

November 15, 2017 By Brad Perriello Leave a Comment

EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the […]

Filed Under: Clinical Trials, Funding Roundup, Regulatory/Compliance, Wall Street Beat Tagged With: Cardiac Rhythm Management, EBR Systems Inc.

EBR Systems wins FDA nod for wireless pacer trial

September 13, 2016 By Fink Densford Leave a Comment

EBR Systems said today it won an investigational device exemption from the FDA for a clinical trial of its WiSE wireless cardiac resynchronization therapy device. The Sunnyvale, Calif.-based company claimed the device as the world’s only wireless, endocardial pacing system for stimulating the left ventricle. “WiSE is unique, significant technology that’s cleared for use in Europe and has proven […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: EBR Systems Inc.

EBR Systems wins CE Mark for wireless pacer

October 7, 2015 By Fink Densford Leave a Comment

EBR Systems said Monday it won CE Mark approval in the European Union for its WiSE wireless endocardial cardiac resynchronization therapy device. The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted on the inside of the heart, in the right ventricle, which it uses to synchronize the left […]

Filed Under: Cardiac Implants, Cardiovascular, Regulatory/Compliance, Structural Heart Tagged With: EBR Systems Inc.

HRS 2015: EBR Systems ‘wireless’ pacer passes safety study

May 14, 2015 By Brad Perriello Leave a Comment

HRS 2015: EBR Systems 'wireless' pacer passes safety study

A feasibility study of the “wireless” pacemaker made by EBR Systems confirmed the device’s safety and pointed the way toward further research, according to Dr. Vivek Reddy of New York’s Mt. Sinai School of Medicine.

Filed Under: News Well Tagged With: Cardiac Rhythm Management, Clinical Trials, EBR Systems Inc.

EBR raises $20m for wireless pacer | Medtech funding for the week of April 13, 2015

April 17, 2015 By MassDevice Leave a Comment

EBR Systems raises $20m for wireless pacer

April 10, 2015 by Mark Hollmer

Filed Under: Funding Roundup, News Well Tagged With: Clear Guide Medical, EBR Systems Inc., Leviticus Cardio, National Institute for Health & Clinical Excellence, Ortho Kinematics Inc., ReCor Medical

EBR Systems raises $20m for wireless pacer

April 10, 2015 By Mark Hollmer Leave a Comment

EBR Systems raises $20m for wireless pacer

Filed Under: Funding Roundup, News Well Tagged With: Cardiac Rhythm Management, EBR Systems Inc.

AtriCure aims for FDA approval with “hybrid” atrial fibrillation trial

May 5, 2011 By MedCity News Leave a Comment

AtriCure

The launch of a pivotal clinical trial next year for a “hybrid” procedure to treat atrial fibrillation patients will be an “inflection point” for cardiac surgical device maker AtriCure Inc.’s (NSDQ:ATRC) U.S. business, the company’s CEO said.

The pivotal clinical trial, which could lead to regulatory approval of the hybrid procedure to treat atrial fibrillation and is called DEEP AF, will involve expanding studies from six research centers to 35, CEO David Drachman said.

Filed Under: News Well Tagged With: AtriCure Inc., BioTime Inc., Cardiac Dimensions Inc., Clinical Trials, Corindus Vascular Robotics, cyberonics, EBR Systems Inc., Lantheus Medical Imaging, Navidea Biopharmaceuticals, pSivida Corp., second-sight-medical

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