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Cardiovascular Devices News

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151-165 of 2593 results
BioStable Science seeks FDA approval for HAART 300 aortic annuloplasty device
Cardiovascular device company BioStable Science & Engineering is seeking approval from the US Food and Drug Administration (FDA) for its HAART 300 aortic annuloplasty device.
Specialty Devices > Cardiovascular Devices > News
Heart Test Labs completes regulatory submission for FDA 510(k) and CE mark
Heart Test Laboratories has announced that it has submitted its 510(K) application to the Food and Drug Administration (FDA) and a CE Mark certification submission to the British Standards Institute (BSI) group for its MyoVista electrocardiographic device.
Specialty Devices > Cardiovascular Devices > News
Medtronic reports one-year clinical trial results of Avalus surgical aortic valve
Medtronic has announced positive clinical data for its investigational Avalus pericardial aortic surgical valve, intended for the treatment of aortic valve disease.
Specialty Devices > Cardiovascular Devices > News
FDA classifies two field actions related to HeartWare HVAD system as class 1 recalls
Medtronic announced that two previously communicated global voluntary recalls related to the HeartWare International (HeartWare) HVAD System have been classified as Class 1 by the U.S. Food and Drug Administration (FDA).
Specialty Devices > Cardiovascular Devices > News
Philips partners with World Heart Federation to prevent cardiovascular disease
Royal Philips announced a new partnership with the World Heart Federation (WHF) to help people better manage their heart health.
Specialty Devices > Cardiovascular Devices > News
Edwards Lifesciences wins CE mark approval for Inspiris Resilia aortic valve
By MDBR Staff Writer
Edwards Lifesciences has received CE mark approval for its Inspiris Resilia aortic valve to treat heart valve patients.
Specialty Devices > Cardiovascular Devices > News
SentreHEART announces closing of $35m funding round for aMAZE trial
SentreHEART, the manufacturer of the LARIAT technology for catheter-based, non-implant left atrial appendage closure (LAAC), announced it has closed a $35m Series D round of financing.
Specialty Devices > Cardiovascular Devices > News
Claret Medical seeks FDA approval for Sentinel cerebral protection system
By MDBR Staff Writer
Claret Medical is seeking approval from the US Food and Drug Administration (FDA) for its Sentinel cerebral protection system (CPS).
Specialty Devices > Cardiovascular Devices > News
Versa Capital buys US medical technology firm SynCardia Systems
By MDBR Staff Writer
Versa Capital Management has acquired US medical technology company SynCardia Systems for an undisclosed sum.
Specialty Devices > Cardiovascular Devices > News
Boston Scientific’s new Lotus Edge valve system wins CE mark approval
By MDBR Staff Writer
Boston Scientific has secured CE mark approval for its Lotus Edge valve system, which is indicated to replace aortic valve in patients with serious aortic stenosis who are considered at high risk for surgical valve replacement.
Specialty Devices > Cardiovascular Devices > News
Shockwave's Lithoplasty system gets FDA approval to treat calcified peripheral artery disease
By MDBR Staff Writer
Shockwave Medical has secured approval from the US Food and Drug Administration (FDA) for its Lithoplasty system to treat calcified plaque in peripheral artery disease (PAD) patients.
Specialty Devices > Cardiovascular Devices > News
Medtronic gets Japanese approval for Reveal LINQ insertable cardiac monitor system
By MDBR Staff Writer
Irish medical technology firm Medtronic has received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for its Reveal LINQ insertable cardiac monitor (ICM) system.
Specialty Devices > Cardiovascular Devices > News
EBR Systems gets FDA IDE approval to begin clinical trial of WiSE CRT system
By MDBR Staff Writer
EBR Systems has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start the pivotal trial of wireless stimulation endocardially (WiSE) for cardiac resynchronization therapy (CRT).
Specialty Devices > Cardiovascular Devices > News
New ESC guidelines support recent Medtronic innovations for patients with atrial fibrillation
Medtronic innovations were acknowledged in updated guidelines published by the European Society of Cardiology (ESC): cryoballoon ablation for patients with diagnosed atrial fibrillation (AF), and long-term cardiac monitoring for survivors of stroke who do not have an established diagnosis of AF.
Specialty Devices > Cardiovascular Devices > News
Terumo to distribute CytoSorb anti-inflammatory device in six European markets
By MDBR Staff Writer
CytoSorbents has partnered with Terumo Cardiovascular Group to sell its CytoSorb extracorporeal blood purification adsorber in six European markets.
Specialty Devices > Cardiovascular Devices > News
151-165 of 2593 results