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Shimmer Research Extends Wearable Sensing Platform for Clinical Trials
Verisense platform can now measure heart rate, oxygen saturation, and emotional responses in addition to overall activity and sleep levels.Michael Barbella, Managing Editor 03.26.21
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First Patient Treated in Pivotal Clinical Trial of Breast Cancer Locator System
Clinical study to evaluate the system’s ability to reduce a positive margin rate.Michael Barbella, Managing Editor 02.02.21
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CarThera Starts New Clinical Trial to Test its SonoCloud-9 Device
Study will determine the safe dose of Abraxane to be used with SonoCloud-9 in recurrent glioblastoma patients.CarThera 01.12.21
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New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System
The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.B3C newswire 01.08.21
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Cardiovascular
Edwards Treats First Patient in Restore Clinical Trial
Evaluates minimally invasive device for mitral valve disease.Edwards Lifesciences Corp. 12.21.20
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Surgical
Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections
The study will use 50 noncardiac, adult operating rooms at Cleveland Clinic.Aerus Medical 12.14.20
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First Patient Enrolled in NovaSignal's Intelligent Ultrasound Clinical Trial
The FDA-cleared NovaGuide is designed to autonomously locate major blood vessels and assess blood flow.Globe Newswire 11.23.20
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Veristat Launches a Flexible Virtual Clinical Trial Solution
Veristat utilizes patient-centric practices to improve clinical trial participation by easing the burden on patients.Business Wire 11.09.20
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Vielight Launches COVID-19 Clinical Trial With Home-Use Device
Study will evaluate whether special light therapy is an effective coronavirus treatment.Globe Newswire 10.14.20
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Digital Health
Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials
Medidata Detect identifies known and unknown risks, and triggers corrective actions.Business Wire 10.05.20
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CVRx Completes Enrollment in BeAT-HF Phase III Randomized Clinical Trial
The company also enrolls the first patient in a post-market heart failure registry.PR Newswire 09.17.20
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ERT Continues to Drive Innovation in Virtualization for Respiratory Clinical Trials
Partnership with Inofab Health keeps respiratory trials on track and ensures patient safety during and after COVID-19.ERT 08.26.20
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Diagnostics
Newsight’s Rapid COVID-19 Detection Test Shows Promise in Clinical Trial
Achieves a 95% success rate under laboratory conditions at Sheba Medical Center.Sheba Medical Center 08.13.20
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Contego Medical Begins Enrollment in PERFORMANCE II Carotid Stenting Clinical Trial
The study will enroll over 300 patients at over 40 sites in the United States and Europe.PR Newswire 08.10.20
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ERT Survey Indicates Swift Adoption of Virtual Clinical Trials Due to COVID-19
More than eight of 10 respondents are implementing elements of virtual trials due to the pandemic.ERT 08.03.20
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First Patient Enrolled in Alucent Biomedical's Natural Vascular Scaffolding Clinical Trial
Multicenter ACTIVATE I Study to enroll up to 15 patients in the United States.Business Wire 07.27.20
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Clinical Trial Begins for Exero Medical’s Wireless Anastomotic Sensor
The study will test the feasibility of Exero’s system for early detection of anastomotic leaks.Exero Medical 07.17.20
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Cardiovascular
AtriCure Announces Results from CONVERGE IDE Clinical Trial
Study showed an 18 percent difference between the Convergent arm and the control arm in evaluable patients at 12 months.Business Wire 07.10.20
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Pivotal Providing Specialized Clinical Research Services for COVID-19 Clinical Trials
Study to discover whether hyperimmune plasma with virus antibodies will benefit patients with COVID-19 acute phase.Targetwire.com 06.25.20
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Patient-Administered ECG Assessment Enables Clinical Trials to Continue During Pandemic
Patients monitor cardiac safety at home with FDA-cleared KardiaMobile 6L personal ECG.ERT 06.19.20
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How Are MPO’s Top 30 Addressing COVID-19?
J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.Online Exclusives Sam Brusco, Associate Editor 06.09.20
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Australia's Clinical Trial Ecosystem Commitment to Benefit Medtech Industry
Country's health department dedicated $614 million in 2019 towards clinical trials being conducted in rural, regional, and remote areas.GlobalData 06.05.20
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Digital Health
Philips Launches HealthSuite Clinical Trial Accelerator
Helps life science organizations run more flexible, patient-centric clinical trials.Philips 05.19.20
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FDA OKs ALung Hemolung Respiratory Assist System to Treat COVID-19
Hemolung can be a valuable tool to be used in conjunction with invasive mechanical ventilation.Business Wire 04.27.20
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Diagnostics
Enzo Biochem Launches COVID-19 Diagnostic Test
Proprietary molecular diagnostic kits offer improved scale, throughput, and sensitivity.Business Wire 04.23.20
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Endonovo Therapeutics Introduces Support of SofPulse With New Patient Brace
The brace allows site-specific application and promotes ease of use for patients and medical professionals when using the SofPulse device.Globe Newswire 04.23.20
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Medtronic Sees Revenue Losses Due to COVID-19 Pandemic
The company says it is well positioned for recovery.Globe Newswire 04.22.20
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Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19
The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.Globe Newswire 04.22.20
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Fist Assist Announces CE Mark and European Launch
Regulatory milestone allows company to expand its commercialization efforts beyond India and into Europe.Business Wire 04.21.20
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COVID-19 Trial Targets Patients With Underlying Medical Conditions
Trials are now waiting IRB approvals and are about to launch under existing contracts at multiple sites including top U.S. universities.Circularity Healthcare 04.21.20
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3D/Additive Manufacturing | Diagnostics
3D-Printed Swabs Could Help Fill Gap in COVID-19 Test Kits
Clinical trials expected to begin by the end of this week.University of Louisville 04.17.20
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BEAT19 Crowdsourcing Study Jump Starts Data Collection for Coronavirus Research
Two hundred forty million Americans can play a vital role in the search for a vaccine or treatment by contributing critical data from home.Globe Newswire 04.16.20
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Non-Invasive Microcirculatory Device Could Help COVID-19 Patients
Product provides non-invasive, transdermal microcirculation to improve overall oxygen-rich blood flow and treat underlying medical conditions.Circularity Healthcare LLC 04.14.20
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EnClear Therapies Announces $10 Million in Series A Financing
Company also adds three to its Board of Directors.Business Wire 04.09.20
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Stroke Care Expert Joins Ischemia Care Advisory Board as Chairman
Newest member has led or participated in numerous Phase II and III clinical stroke trials over the past 20 years.Business Wire 04.09.20
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monARC Bionetworks CEO Joins Glooko as Chief Operating Officer
Company also recruits LexisNexis Health Care executive for chief commercial officer job.Glooko 04.07.20
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PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables
Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.PhysIQ 04.07.20
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Surgical
Olympus' Non-Surgical BPH Device Wins FDA De Novo
The iTind flexible three-strut nitinol device can be placed during an in-office procedure.Olympus 04.06.20
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3D/Additive Manufacturing
Materialise's 3D Printed Oxygen Mask Helps Ventilator Shortage
COVID-19 solution brought to hospitals quickly and in full compliance with safety regulations.Videos Materialise
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Diagnostics
COVID-19 At-Home Test Ready for Validation Study
Care Access Research will lead clinical trials of the coronavirus test.Care Access Research 04.03.20
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Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic
A reminder of what manufacturers should keep in mind during this turbulent time.Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20
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Diagnostics
Biomerica Working With N.Y. Medical School on COVID-19 Antibody Test
Once developed and scaled-up, the company’s existing production capacity could allow for more than 1 million tests per month.Globe Newswire 04.02.20
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R&D & Design
Why Outsourcing Is in: Piecing Out Projects Makes Sense
Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.Dawn A. Lissy, President & Founder, Empirical 04.01.20
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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
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CORRECTION: Bodysphere's Two-Minute Serological Test Kit To Detect Novel Coronavirus
Company incorrectly indicated the test had acquired an Emergency Use Authorization from the FDA.Sean Fenske, Editor-in-Chief 03.31.20
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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
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FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test
Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.Globe Newswire 03.30.20
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Cardiovascular
Edwards Pauses Enrollments in Pivotal Mitral, Tricuspid Trials
Decision was made in response to hospitals' focus on COVID-19.PR Newswire 03.30.20
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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
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Diagnostics
BD Completes Clinical Trial for BD Libertas Wearable Injector
The drug delivery system is currently in development and is designed to deliver biologics with viscosities up to 50 cP.B3C newswire 03.27.20
