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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
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Diagnostics
BurstIQ and FlowMetric Life Sciences Launch Novel Vaccine Immune Response Test
The VaxEffect platform empowers both patients and providers to make more informed health decisions.07.23.21
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EPTAM Precision Acquires Mendell Machine and Manufacturing
Deal allows the companies to combine complimentary capabilities.Business Wire 07.23.21
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Venture Capital Fund Launched for Early-Stage Medical Device Firms, Products
Fund from E-merge Capital Partners to focus on disruptive medical technologies with the potential to transform patient outcomes.Business Wire 07.23.21
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Materials
Electronics Integration Impacting Medtech Materials
Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.Online Exclusives Michael Barbella, Managing Editor 07.23.21
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3D/Additive Manufacturing | Molding
Metal Injection Molding and Metal 3D Printing Examination
Both MIM and metal AM serve as alternative options to machining for medtech manufacturers requiring metal components.Mark Crawford, Contributing Writer 07.22.21
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3D/Additive Manufacturing
Back in 3D: AMUG Conference Welcomes Members in the Flesh
This was my first visit to AMUG; I spoke about the role of the FDA in regulating medical devices produced via AM.Dawn A. Lissy, Founder & President, Empirical 07.22.21
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COVID and the U.S.-China Medtech Relationship
The pandemic has occasioned a drastic realignment of the United States’ leading medtech suppliers.Mihir Torsekar, Director of the Global Trade Desk, Level International 07.22.21
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Testing
Guidance on Skin Irritation With a Push to Achieve the 3 Rs
The publication of ISO 10993-23:2021 marks a paradigm shift in prioritizing in-vitro testing alternatives within the medical device biocompatibility space.Nick Hibbard, In-Vitro Scientific Research Fellow at WuXi AppTec Medical Device Testing 07.22.21
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The Top 30 and Their Impact on the C-Suite
MPO’s top companies report is an excellent time to reflect upon the wide range of impacts these industry giants have on the medical device industry.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 07.22.21
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Tips for Protecting Intellectual Property to Secure Funding
This column provides tips on how to ensure a medtech company’s other valuable intellectual property is ready for due diligence.Roman Fayerberg, David J. Dykeman, Todd Basile, Registered Patent Attorneys, Greenberg Traurig LLP 07.22.21
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MEDICAL & BIOTECH MANUFACTURING
ISO 13485:2016 • FDA Registered
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Philips Introduces the New Spectral Computed Tomography 7500 System
Intelligent system provides spectral data for all patients, including cardiac, pediatric, and bariatric.Royal Philips 07.22.21
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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
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Cardiovascular
Philips' Laser-Assisted IVC Filter Removal Device Earns Breakthrough Status
Intended for ablating tissue to remove IVC filter when previous removal methods have failed.GlobeNewswire 07.21.21
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Software & IT | Surgical
Hillrom Launches Helion Integrated Surgical System in U.S.
Provides operating room connectivity, flexibility, and efficient staff communications.PR Newswire 07.21.21
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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
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Electronics
Electronic Medical Device Design Considerations—A Medtech Makers Q&A
Ensuring the proper connections are made can be a greater challenge than device manufacturers may realize.
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Diagnostics
Nova POC Creatinine/eGFR Method More Accurate Than Lab Method
One of the first studies to compare the accuracy of POC creatinine/eGFR devices to iohexol mGFR method yields promising results.Nova Biomedical 07.20.21
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Cutera Appoints Sheila Hopkins to its Board of Directors
Newest member was executive vice president and president, Global Vision Care, for Bausch + Lomb.Business Wire 07.20.21
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Chronic Disease
Integra Highlights Data from Diabetic Foot Ulcer Study
Positive clinical outcomes for PriMatrix dermal repair scaffold for management of hard to heal diabetic foot ulcers.GlobeNewswire 07.20.21
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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
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Cardiovascular
Endologix's ChEVAS System Gains Breakthrough Status
Investigational EVAS system designed for patients with complex abdominal aortic aneurysm.Business Wire 07.20.21
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Diagnostics
Owlstone Medical Launches Breath Testing for Digestive Health
Testing enables patients to take better control over their digestive health through a simple at-home breath test.Owlstone Medical 07.19.21
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Chronic Disease | Software & IT
Dexcom's Real-Time APIs for Third-Party Apps, Devices Earn FDA Nod
Gives Dexcom users more choice in where and how they interact with their glucose data.Business Wire 07.16.21
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Surgical
FDA OK's Palliare's EVA15 Insufflation for Endoscopic Surgery
Shipments of new END-200 tubeset to commence in Q4-2021.Business Wire 07.16.21
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Patient Monitoring
Philips introduces integrated Interventional Hemodynamic System
The system features the Patient Monitor IntelliVue X3 to improve workflow and patient focus during image-guided procedures.Royal Philips 07.16.21
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DaVita, Former CEO Indicted on Labor Collusion Charges
U.S. government claims the chief executive conspired with other companies to block the hiring of certain workers.U.S. Department of Justice 07.16.21
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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
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Kathy Sherwood Joins Pelvital USA Board of Directors
New member has more than 30 years of medical device industry experience.Business Wire 07.15.21
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Patient Monitoring
Spacelabs, Masimo Partner on Patient Monitoring Advancements
Collaboration to bring brain function monitoring, and O3 regional oximetry into select Spacelabs multi-parameter monitors.Business Wire 07.15.21
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Integra Receives Innovative Technology Contract from Vizient
Contract is for SurgiMend collagen matrix for soft tissue reconstruction.GlobeNewswire 07.15.21
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Diagnostics
NanoDx Inc. Enters Licensing Agreement with IBM Research
Collaboration aims to enhance and expand accurate, rapid testing for several indications, including COVID-19, Traumatic Brain Injury, Sepsis and Stroke.NanoDx Inc. 07.15.21
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Digital Health
DataRobot Launches AI for Health Incubator
Company is accelerating critical healthcare research to help physicians and medical professionals better leverage AI.Business Wire 07.14.21
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VistaMed, OneProjects and Tyndall Receive €5.1 million to Improve Treatment of Cardiac Arrhythmias
Project aims to provide a catheter to deliver direct 3D, intraprocedural analysis of the success of cardiac ablation, in the treatment of atrial fibrillation.VistaMed 07.14.21
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Patient Monitoring
Survey: Patient Focus Breeds Success for Remote Cardiac Monitoring Programs
Data show practices struggle to keep patients engaged in their care, straining staff and making it impossible for clinical and financial benefits to be realizedBusiness Wire 07.14.21
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Digital Health
Tilak Healthcare Launches U.S. Pilot for Medical Vision Monitoring App
The smartphone app is especially suited to monitor patients with chronic eye diseases associated with aging.Business Wire 07.14.21
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Diagnostics
Hologic Gains CE Mark for Saliva Samples with COVID-19 Test
Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.Business Wire 07.14.21
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Substantial Growth Predicted for Global Ventilators Market
Aging population, increasing infectious disease rates to drive growth through 2026.Market Study Report 07.13.21
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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
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Cardiovascular
Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina
Company expands global reach with latest endovascular aneurysm repair technology.07.13.21
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Patient Monitoring
Canary Medical’s ‘Smart’ Implants
MPO's Sean Fenske speaks with Dr. Bill Hunter of Canary Medical about his firm’s smart implant technology for orthopedics.Sean Fenske, Editor-in-Chief 07.13.21
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Digital Health
Heartbeat Health Raises $20 Million Series B Funding
Money will be used to expand virtual heart care.Business Wire 07.12.21
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Materials
Specialty Wire Benefits for Manufacturers—A Medtech Makers Q&A
Ulbrich Specialty Wire Products’ Ed Treglia and Ryan McFarland speak to specification considerations for wire for medical applications.
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3D/Additive Manufacturing
Desktop Health Adds PhonoGraft Platform to Its Technology Platform
Will support the body’s functional and morphological regeneration of the tympanic membrane.Desktop Health 07.09.21
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Contraline Expands Board of Directors
Medical device industry veteran Martin J. Emerson has joined the company's board.Business Wire 07.09.21
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Digital Health
ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance
Compliant transmission of medical grade data from the home enables providers to safely monitor patients and meet demand for scalable remote care.Business Wire 07.09.21
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Cardiovascular | Patient Monitoring
FDA OKs QTc Interval Measurement for AliveCor's Personal ECG
Long QTc interval is a potentially life-threatening side effect of certain medications.PR Newswire 07.09.21
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Diagnostics
Lumos Diagnostics Appoints Three Industry Leaders as Independent Directors
Trio brings strong knowledge of equity markets and broad corporate governance expertise to the firm.Business Wire 07.09.21
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Digital Health
Philips, Cognizant Ink Digital Health Solutions Collaboration
Pairs cloud-based healthcare platform with experience-oriented application design.Philips 07.09.21
