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Cardiovascular Devices

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
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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
St. Jude Medical files lawsuit against Muddy Waters and MedSec over false claims
By MDBR Staff Writer
St. Jude Medical has filed a lawsuit against Muddy Waters Consulting, Muddy Waters Capital, MedSec Holdings and MedSec, claiming that the companies have intentionally provided misleading information to reduce the value of its stock.
Specialty Devices > Cardiovascular Devices > News
St. Jude Medical begins clinical trial of Amplatzer Amulet LAA occluder
St. Jude Medical has launched global clinical trial to assess a new therapy option for patients at an increased risk of stroke due to atrial fibrillation (AF).
Specialty Devices > Cardiovascular Devices > News
St. Jude Medical continues to refute allegations made by Muddy Waters Capital and MedSec
St. Jude Medical, a global medical device company, issued the following statement:
Specialty Devices > Cardiovascular Devices > News
Medtronic technologies enhance delivery of cardiac resynchronization therapy
By MDBR Staff Writer
Medtronic has presented data on EffectivCRT for heart failure patients with atrial fibrillation (AF) at the 2016 European Society of Cardiology (ESC) Congress in Rome, Italy.
Specialty Devices > Cardiovascular Devices > News
NICE set to recommend device to help spot heart disease using 3D models of blood vessels
Medical software that creates 3D models of blood vessels in the heart to help clinicians diagnose heart disease is the subject of NICE’s latest draft medical technologies guidance.
Specialty Devices > Cardiovascular Devices > News
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