Medical Product Outsourcing

Optimize EP Launches CaRM Cardiac Device Data Management Platform

Digital tool automates workflow processes and enhances data algorithms to efficiently improve patient care.

Accesswire 01.15.21

FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.

PR Newswire 01.14.21

Diagnostics

RSIP Vision Announces New Cardiac Diagnostic Tool for PoC Ultrasound Screening

New algorithmic module provides an automated expert-level assessment of heart function for point of care medical teams.

RSIP Vision 12.16.20

First National Pediatric Cardiac Screening Database is Established

FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening.

Business Wire 11.30.20

Cardiovascular

VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution

Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.

Business Wire 11.23.20

Cardiovascular

Medtech Matters: AI-Enabled Cardiac Diagnostics

MPO's Sean Fenske speaks with Cardiologs’ Mark Toland and Rick Anderson about the rapidly evolving technology to help address cardiovascular disease.

Sean Fenske, Editor-in-Chief 11.18.20

Cardiovascular

First Patients Treated With Pulsed Electric Field Cardiac Ablation System

Galaxy Medical's Centauri System is designed as an open energy platform with proprietary interface hardware and waveform control algorithms.

PR Newswire 11.17.20

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 | Surgical

FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System

Allows electrophysiologists to visualize 3D electroanatomic models in real-time, via a wearable headset.

PR Newswire 09.30.20

Cardiovascular

Transformative Raises $1.7 Million Seed Round for Sudden Cardiac Arrest Tech

The company's patented software analyzes data from standard patient monitoring devices in hospitals.

Business Wire 09.21.20

Avive Solutions Raises Additional $7 Million for Cardiac Arrest Response Technology

The funds will accelerate the company’s development of its platform solution.

Business Wire 08.27.20

Cardiovascular | Patient Monitoring

Medtronic's Linq II Insertable Cardiac Monitor Earns FDA Nod, CE Mark

Next-gen ICM offers remote programming, improved longevity, and enhanced accuracy.

GlobeNewswire 07.08.20

Cardiovascular

Boston Scientific's Insertable Cardiac Monitor System Cleared by FDA

Detects arrhythmias associated with heart conditions.

PRNewswire 06.29.20

AtaCor Medical Secures $25 Million for Extracardiac Pacing Development

The company is developing cardiac pacing therapies that do not require any hardware to be placed inside or onto a patient’s heart.

Business Wire 06.25.20

Precordior Awarded Funding to Develop Smartphone-Enabled Cardiac Disease Detector

Research has proven that measurement and analysis of a patient’s chest’s micro-movements and vibrations can identify cardiac diseases and conditions.

Presswire 05.26.20

Cardiovascular | Digital Health

Eko Launches First AI Telehealth Platform for Virtual Pulmonary and Cardiac Exams

Provides clinicians with in-person level exam capabilities during video visits.

Business Wire 05.20.20

Cardiovascular

Impulse Dynamics Appoints Cardiac Electrophysiologist as Medical Director

New executive has spent nearly two decades treating heart failure patients.

Business Wire 05.18.20

Cardiovascular | Patient Monitoring

FDA Grants EUA to VitalConnect's Cardiac Monitoring in COVID-19 Patients

VitalPatch wearable biosensor can monitor for heart-related side effects of Hydroxychloroquine and other treatments.

PR Newswire 05.06.20

Aria CV Announces $31 Million in Series B Funding

Money will support the Aria CV Pulmonary Hypertension System Feasibility Study.

Business Wire 04.24.20

Cardiovascular

VisCardia's Heart Failure Therapy Gains Breakthrough Designation

Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.

NewsWire 04.23.20

Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

The company says it is well positioned for recovery.

Globe Newswire 04.22.20

Cardiovascular

Transcatheter Tricuspid Valve Replacement System Gains Breakthrough Status

Cardiovalve is first company to receive FDA early feasibility study approval for both tricuspid regurgitation and mitral regurgitation indications.

Business Wire 04.17.20

HeartVista Forms Medical and Scientific Advisory Board

Governing body comprised of leaders from Stanford University and the University of Wisconsin.

Business Wire 04.16.20

Device Measures QT Segments in COVID-19 Patients Using Hydroxychloroquine

BardyDx’s CAM Patch will be used at hospitals across the Seattle area to monitor cardiac rhythms for COVID-19 patients on HCQ.

Bardy Diagnostics Inc. 04.09.20

Diagnostics

Nova Biomedical Adds PT/INR Test to Allegro Analyzer

New PT/INR test are available now for purchase in CE regulated countries.

Nova Biomedical 04.07.20

Software & IT

Seeking Software Partners During a Crisis

The COVID-19 pandemic has caught many unprepared to handle increased challenges, leaving them to find assistance.

Online Exclusives Svetlana Anishchenko, Director of Marketing, Auriga Inc. 04.07.20

Cardiovascular | Surgical

Boston Scientific Recalls Imager II Angiographic Catheters

Catheter tip may detach during a procedure or preparation; nine reported injuries.

U.S. Food and Drug Administration 04.07.20

Cardiovascular

VADovations Secures Investment, Development Agreement for Percutaneous Endovascular Delivery System

Product is designed to avoid open surgical implantation while addressing the limitations of current blood pumps.

Business Wire 04.03.20

Digital Health

Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

Michael Barbella, Managing Editor 04.01.20

Tubing & Extrusion

Pathways to Care: Tubing Technologies

Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.

Mark Crawford, Contributing Writer 04.01.20

The Economics of a Sound Regulatory Strategy

While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.

Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20

Cardiovascular

Cardiac Patch with Bioink Could Repair the Heart

Enhances functionality of stem cells to regenerate blood vessels.

Pohang University of Science & Technology (POSTECH) 03.31.20

Cardiovascular

FDA Approves ZOLL's Next-Gen TherOx System for 'Widowmaker' Heart Attacks

SSO2 Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle.

Business Wire 03.30.20

Cardiovascular

Medtronic Releases Evolut Low Risk Bicuspid Study Results

Low rates of paravalvular leak, high survival observed in late-breaking clinical trial.

GlobeNewswire 03.30.20

Philips to Assess PCI Outcomes Using Integrated iFR Technology

Global multi-center study will compare outcomes between physiological guidance by iFR data co-registered on the angiogram vs. angiogram alone.

Royal Philips 03.27.20

Doctors Construct Makeshift Ventilators for COVID-19 Fight

University of Minnesota physicians collaborate on low-cost solution to help treat patients.

Videos University of Minnesota

Cardiovascular | Patient Monitoring

FDA OKs AliveCor's KardiaMobile 6L to Measure QTc in COVID-19 Patients

Monitors QT duration in patients receiving medications that can cause potentially life-threatening QT prolongation.

PR Newswire 03.24.20

4 Medical Manufacturing Trends Driving Growth in 2020

Medical device manufacturing is poised for 5.6 percent growth each year between 2017 and 2023.

Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 03.17.20

Paragonix Reports First Successful Use of its SherpaPak Cardiac Transport System

Product is the only FDA-cleared and CE-marked device that safeguards hearts between donor and recipient patients.

Business Wire 03.17.20

Lantheus Reveals Disappointing Clinical Trial Results for Ultrasound Contrast Agent

The endpoints for the company's BENEFIT 1 study were not met.

Business Wire 03.13.20

Cardiovascular

Ancora Heart Expands U.S. Early Feasibility Study

CorCinch HFrEF study is evaluating the safety of AccuCinch Ventricular Repair System in heart failure patients.

Business Wire 03.12.20

Cardiovascular

Remote Patient Monitoring is the Future of Cardiovascular Disease Management

Trends in non-wearable remote patient monitoring technology focus on digital and electronic stethoscopes, contact-free patient monitoring and portable devices.

IDTechEx 03.10.20

Cardiovascular | Surgical

FDA OKs Stereotaxis' Genesis Robotic Magnetic Navigation

Robotic navigation of magnetic ablation catheters treats heart rhythm disorders.

GlobeNewswire 03.06.20

Cardiovascular

CE Mark for Abbott’s FlexNav Delivery System for TAVI Valve

The system improves control and delivery of the Portico TAVI valve even in complex clinical cases.

PR Newswire 03.05.20

Mayo Clinic Doctor Becomes BIOTRONIK'S First Chief Medical Officer

New executive expected to drive collaboration between physicians, clinical research, and technological development.

PR Newswire 03.05.20

Cardiovascular

Vision-MR Ablation Catheter Receives CE Mark

Product is designed to work under real-time MRI guidance, to help clinicians achieve higher success rates and provide safer cardiac catheter placements.

Business Wire 03.05.20

R&D & Design

Four Considerations for Developers of Next-Generation Combination Products

Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.

Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20

Cardiovascular

Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies

Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.

Sam Brusco, Associate Editor 03.04.20