Medical Product Outsourcing

Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.

Electroducer 09.21.21

Cardiovascular

Company Uses AI, Machine Learning to Tackle Heart Disease

Cleerly was founded in 2017 to leverage advanced imaging science to identify people at risk of heart attacks.

Business Wire 09.08.21

Cardiovascular

FDA Approves TransMedics' OCS Heart System for Donor Hearts

Indicated for preservation of DBD (donors after brain death) hearts.

PR Newswire 09.07.21

Cardiovascular

Abiomed's Impella ECP Heart Pump Granted Breakthrough Status

The world’s smallest heart pump, according to the company.

Business Wire 08.19.21

Cardiovascular

Catheter Ablation is Cost-Effective Treatment for Irregular Heartbeat

First-ever analysis of CABANA trial reveals economic benefits of catheter ablation compared to drug therapy.

Heart Rhythm Society 08.06.21

Cardiovascular

FDA OKs Abbott's AI OCT Imaging for Vessels in the Heart

Ultreon 1.0 Software is the first-of-its-kind imaging software according to the company.

PR Newswire 08.04.21

Digital Health

Hello Heart Raises $45M to Expand Digital Heart Health Platform

Series C financing was led by IVP and includes existing investors.

Business Wire 08.02.21

Cardiovascular | Digital Health

BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status

Augments guideline-directed use of heart failure medications.

PR Newswire 07.30.21

Cardiovascular

Successful First Human Use of Foldex's Biopolymer Mitral Heart Valve

Second product from Tria Biopolymer Valve portfolio to move into human study.

Business Wire 07.30.21

Cardiovascular

Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes

The interactive planning tool enables heart teams to modify vessels virtually and determine the optimal treatment strategy before procedures.

Business Wire 07.23.21

Cardiovascular

Study Data Show MobiusHD Device is a Safe Heart Failure Treatment

Company also adds Stan Rabinovich to its Board of Directors.

Business Wire 07.22.21

Cardiovascular | Digital Health

Studies Show AI-Driven Blood Test Accurately Predicts Heart Attack Risk

Data indicate the test also can correctly portend stroke and cardiac death risk.

Business Wire 07.21.21

Cardiovascular

CARMAT Celebrates First Aeson Artificial Heart Commercial Implant

Represents first CARMAT sale, paves the way for the company’s commercial development.

Business Wire 07.20.21

Cardiovascular

HeartFlow to Go Public in $2.8B Merger Deal

HeartFlow’s artificial intelligence-enabled software platform brings precision heart care to cardiology.

HeartFlow Inc. 07.15.21

Cardiovascular

HeartFlow Completes Patient Enrollment in the PRECISE Trial

More than 2,000 patients enrolled in randomized controlled trial to evaluate a precision-testing pathway for suspected coronary artery disease.

Business Wire 07.13.21

Digital Health

Heartbeat Health Raises $20 Million Series B Funding

Money will be used to expand virtual heart care.

Business Wire 07.12.21

Cardiovascular

St. Jude Fined $27M for Allegedly Selling Defective Heart Devices

Allegedly failed to disclose serious adverse health events in connection with premature battery depletion.

U.S. Department of Justice 07.09.21

Cardiovascular

FineHeart Successfully Implants, Removes Cardiac Device in Trial

Study showed the device is easily removed with a beating heart 30 days after implantation without damaging the myocardium.

Business Wire 07.07.21

Cardiovascular

FDA Approves Abiomed's Next-Gen Impella RP for Right Heart Failure

Safe and effective to treat acute right heart failure for up to 14 days.

Business Wire 06.29.21

Cardiovascular

Paragonix Study Shows Improved Outcomes for Heart Transplant Patients

Donor hearts preserved by the company's SherpaPak had statistically significant increases in total ischemic time and travel distance.

Business Wire 06.28.21

Cardiovascular

Abiomed Buys preCARDIA, a Heart Failure Tech Firm

preCARDIA system treats acute decompensated heart failure.

Sam Brusco, Associate Editor 06.01.21

Cardiovascular | Patient Monitoring

Abbott Begins Trial for Patients with Simultaneous AFib and Heart Failure

Will use cardiac ablation and sensors to monitor pulmonary artery pressure and abnormal heartbeats.

Sam Brusco, Associate Editor 05.06.21

PolyVascular Awarded $2 Million Grant to Study Pediatric Heart Valve

Company hires Will Clifton as COO to manage the path to human trials in the United States.

Michael Barbella, Managing Editor 05.06.21

Cardiovascular

Getinge Heart Lung Machine Becomes Available for European Hospitals

The HL 40 is designed to increase safety and ensure maximum uptime in cardiac surgery.

Charles Sternberg, Assistant Editor 04.23.21

Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status

Company initiates an early feasibility study in the United States.

Michael Barbella, Managing Editor 04.07.21

Cardiovascular | Surgical

Home Is Where the Heart (Valve) Is

Artificial heart valve makers reached a number of milestones despite the pandemic’s global squeeze.

Sam Brusco, Associate Editor 04.01.21

Cardiovascular

Heart Failure Treatment Using Electrical Microcurrent Shows Promise

Berlin Heals' C-MIC device restores endogenous electric potential gradients using microcurrents, leading to improved myocardial function.

Michael Barbella, Managing Editor 03.30.21

Cardiovascular

FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.

Sam Brusco, Associate Editor 03.26.21

Cardiovascular

Medtech Matters: Treating Hearts Post-Attack

MPO's Sean Fenske speaks with Ken Miller of BioVentrix about how his LIVE Therapy system is helping heart attack victims recover.

Sean Fenske, Editor-in-Chief 03.09.21

Cardiovascular

Novel Heart Failure Treatment Technology Scores Positive Trial Results

All patients treated with Vascular Dynamics' MobiusHD Device showed improvement.

Michael Barbella, Managing Editor 03.01.21

Cardiovascular

FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.

Michael Barbella, Managing Editor 02.25.21

FDA Clears B-Secur's HeartKey EKG/ECG Technology

The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.

Michael Barbella, Managing Editor 02.19.21

Cardiovascular | Surgical

Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

UBC Okanagan research could transform the current gold standard for heart valves.

Sam Brusco, Associate Editor 01.27.21

Cardiovascular

First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.

Business Wire 01.21.21

Cardiovascular

FineHeart Successfully Tests Wireless TET System

A breakthrough in treating patients with severe heart failure.

FineHeart 01.18.21

Cardiovascular

WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.

Business Wire 01.13.21

Cardiovascular | Surgical

Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

Valve designs intended to resist calcification, withstand stresses and strains without failure.

Business Wire 12.14.20

Cardiovascular

LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M

Enables company to sharpen its focus within primary platforms, neuromodulation and cardiovascular.

Business Wire 12.03.20

Cardiovascular

Improved Outcomes Seen in More Complete Revascularization Using Impella Heart Pumps

Impella use led to a 29 percent reduction in MACCE at 90 days.

Business Wire 11.30.20

Cardiovascular

CARMAT Receives Funding to Conduct Artificial Heart Study in France

Two-thirds of the study's total cost will be financed by the French state.

CARMAT 11.19.20

3D/Additive Manufacturing | Cardiovascular | Surgical

3D-Printed, Lifelike Heart Models Could Help Train Future Surgeons

The heart model was structurally accurate and reproducible.

Videos American Chemical Society

Transcatheter Heart Valve Markets Forecast to Grow Despite Second COVID-19 Wave

But valve implantation and repair markets experienced a pandemic-related dip due to procedures being delayed.

GlobalData 11.06.20

HeartHero Inc. Awarded ISO 13485 Certification

Company to continue regulatory path for AED in collaboration with the American College of Cardiology.

Business Wire 11.05.20

Cardiovascular

The Heart of the Matter: Trends in Cardiology

Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.

Maria Shepherd, President and Founder, Medi-Vantage 11.04.20

Cardiovascular | Electronics | Patient Monitoring

Rubbery Bioelectronic Cardiac Patch Can Monitor, Treat Heart Disease

The device can also harvest energy from the heart beating.

University of Houston 11.04.20

Cardiovascular | Patient Monitoring

FDA OKs First Prescriptible Wearable for Continuous Heart Monitoring

Will significantly improve screening and treatment of AFib and other chronic heart conditions.

PR Newswire 10.16.20

Cardiovascular

Coverage Policy Changes for Ventricular Assist Devices to Impact Heart Failure Product Market

Proposed CMS changes will preserve patient access for all labeled VADs currently on the market.

GlobalData 10.06.20

Cardiovascular

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