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Topic: Cardiology

article icon article
Cardiology FDA Approved Structural Heart

Endologix wins FDA approval for abdominal stent graft system

Endologix today said it received FDA approval for its Alto Abdominal Stent Graft System. The […]

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Cardiology Funding Wearables

Element Science collects nearly $150M Series C for wearable personal defibrillator patch

Element Science, a San Francisco startup developing a wearable personal defibrillator, brought in $145.6 million […]

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Cardiology Digital Health Funding

Cardiologist’s digital health startup raises $8.2M

Heartbeat Health, a digital health startup founded by a cardiologist, raised $8.2 million in series […]

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Cardiology CE Mark Neuro

TriGUARD 3 Wins CE Mark for Cerebral Protection During Transcatheter Heart Procedures

Keystone Heart Ltd. announced that is has received the European CE Mark for its TriGUARD 3, […]

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Cardiology Radiology Robotics

Stereotaxis Genesis Robotic Magnetic Navigation System Cleared in U.S.

Stereotaxis, with offices in St. Louis, MO and the Netherlands, has won FDA clearance for […]

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Cardiology FDA

TransMedics to get FDA expert review for heart transplant device PMA

Dive Brief: FDA plans to convene a group of circulatory system device experts April 16 […]

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Cardiology Pediatrics Sensors

Advanced Wireless Neonatal Body Monitors to Improve Outcomes

Babies that end up in the neonatal intensive care unit (NICU) or pediatric intensive care […]

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Cardiology CE Mark Digital Health

Biobeat Receives EU Clearance for Vital Sign Monitoring with Wristwatch and Patch

Biobeat announced recently that it has received CE Mark approval for its patch and wristwatch […]

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Cardiology FDA

FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death

Dive Brief: FDA issued a Class I device recall notice this week regarding Medtronic’s HeartWare […]

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Cardiology FDA Approved Pediatrics Surgery

Masimo Receives FDA Approval for Continuous RRp Monitoring

Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) […]

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Cardiology CE Mark Surgery

V-Wave Shunt for Relief of Heart Failure Symptoms Cleared in EU

Heart failure patients often suffer from high pressure within the left side of their hearts, […]

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Biotech Cardiology FDA

ClotChip Receives FDA Breakthrough Device Designation for Real-Time Coagulation Testing

Cleveland-based XaTek Inc. announced receiving FDA Breakthrough Device designation for ClotChip, a handheld device that […]

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Cardiology Radiology Surgery

Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve

Abbott announced that it received the EU CE Mark for the new FlexNav delivery system […]

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Cardiology Structural Heart Surgery

CryoLife Wins EU CE Mark for E-vita Open NEO Hybrid Stent Graft

CryoLife, Inc., a company based outside of Atlanta, Georgia, announced this week that it has […]

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Cardiology CE Mark Implantables

V-Wave lands CE Mark for heart-failure device

V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark. The Caesarea, […]

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Cardiology Structural Heart

Cardiologist groups back Abbott push to change heart device coverage

Dive Brief: Healthcare professionals have voiced support for Abbott’s request for CMS to stop using […]

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Cardiology Wearables

Jewel Wearable Cardioverter Defibrillator Could Help Prevent Sudden Cardiac Deaths

In the United States sudden cardiac death (SCD) claims 325,000 lives every year. SCDs are […]

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Cardiology Radiology Surgery

Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System

Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. […]

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Cardiology Surgery Vascular

Artificial Self-Assembled Blood Vessels

A team of researchers headed by groups at University of Nottingham and Queen Mary University […]

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Cardiology FDA

Some pacemakers, EKGs, diabetes devices face newly flagged Bluetooth cyber risk

Dive Brief: FDA is warning that a wide range of medical devices using a wireless […]

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Cardiology Funding Wearables

Element Science raises $146M to fund rival to Zoll's wearable LifeVest

Dive Brief: Element Science has raised $145.6 million in Series C financing t​o bring to […]

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Cardiology Diagnostics Surgery

RESPMETER Opioid Overdose Detector Wins FDA Breakthrough Device Status

Altair Medical recently announced that it received FDA Breakthrough Device status for its RESPMETER wearable […]

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Cardiology Implantables Surgery

On-X Ascending Aortic Prosthesis Cleared in EU

CryoLife, based in Kennesaw, Georgia, won EU regulatory clearance for the On-X Ascending Aortic Prosthesis […]

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Cardiology Radiology Surgery

New HydroPICC Prevents Clogged Central Line Catheters

Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its […]

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Cardiology Pediatrics Surgery

FDA Clears First Pulse Oximeter to Measure Breathing Rate

Masimo just received the first FDA clearance for a fingertip pulse oximeter that can measure […]

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Cardiology M&A Neuro

Is Medtronic eyeing LivaNova for a takeover?

Some industry analysts are speculating that Medtronic (NYSE:MDT) might want to acquire LivaNova (NSDQ:LIVN) for its neuromodulation business. A […]

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Cardiology CE Mark Structural Heart

CryoLife wins CE Mark for ascending aortic prosthesis

CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for […]

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Cardiology Diagnostics Wearables

Verily Partnership Could Play a Big Role in iRhythm’s Future

iRhythm Technology’s work with Verily could play an important role for the company this year. […]

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Cardiology M&A Neuro

Medtronic Rumored to Be Looking at a Deal with LivaNova

Reorg Research reported that Medtronic is in early-stage acquisition talks with LivaNova, news that has been […]

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Cardiology Funding Implantables

Aria CV Wants to Offer a Device Option for Pulmonary Arterial Hypertension

Aria CV is venturing into a space that few medtech companies have gone before. The […]

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Cardiology Pediatrics Structural Heart

Adjustable Heart Valves Grow with Kids Hearts

A variety of congenital cardiac abnormalities require the placement of prosthetic heart valves in very […]

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Cardiology FDA Cleared

CHF Solutions wins FDA nod for Aquadex SmartFlow pediatric indication

CHF Solutions (NSDQ:CHFS) announced today that it received FDA 510(k) clearance for its next-generation Aquadex SmartFlow […]

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Cardiology Funding Vascular

Aria CV nets $31M to support first US clinical study of its implant

Aria CV has landed $31 million in Series B funding that will support the first […]

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Cardiology Funding Vascular

Aria completes $31m Series B for its pulmonary hypertension treatment device

Pulmonary arterial hypertension (PAH) treatment developer Aria CV announced today that it completed a $31 million Series […]

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Cardiology FDA Cleared Surgery

LivaNova gets nod for heater-cooler device changes to cut contamination risk

Dive Brief: LivaNova has received 510(k) clearance for a modification to its Heater-Cooler System 3T […]

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Cardiology FDA Cleared Structural Heart

Analysis casts doubt on Boston Scientific TAVR embolic protection device

Dive Brief: A research letter and editorial published online Monday in JAMA Internal Medicine renews […]

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Cardiology Digital Health FDA

J&J and Apple Begin Enrollment for Heartline Study

In the past few years, Apple has greatly increased its presence in healthcare. The Cupertino, […]

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Cardiology FDA Cleared Surgery

Abbott’s Gallant Cardiac Implants Cleared in Europe

Abbott won clearance in the European Union for its new Gallant implantable cardioverter defibrillator (ICD) […]

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Cardiology FDA Cleared Surgery

Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment

Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation […]

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Original post by MassDevice

Written by: Danielle Kirsh

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