Search Results for 'renal disease'
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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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CloudCath Announces $12 Million Series A Financing
Funds will be used to advance commercialization of technology enabling remote, real-time complication monitoring for at-home dialysis.Business Wire 04.07.20
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Medtronic Drug-Coated Balloon Approved by FDA
Designed to treat arteriovenous fistula lesions.Medtronic plc. 11.22.19
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FDA Encourages Patient Engagement in Medical Device Clinical Investigations
The agency is releasing draft guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.U.S. Food and Drug Administration 09.24.19
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Materials | Packaging & Sterilization | R&D & Design
Case in Point: Robust Sintered PTFE Material Helps to Reduce Risk of HAIs
...Jack Chan, Global Marketing Director—Medical, Porex 07.30.19
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Electronics
Hydration Sensor Could Improve Dialysis
Noninvasive device could benefit patients with kidney disease, congestive heart failure, or dehydration.Videos Anne Trafton, MIT News Office
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CVS Health Begins Home Hemodialysis Trial
HemoCare Hemodialysis System is designed for home dialysis to enable patients to benefit from longer treatment as compared to in-center treatments.PR Newswire 07.17.19
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R&D & Design | Surgical | Testing
New Technology May Lead to Implantable Artificial Kidneys
Kidney researchers develop pioneering breakthrough in blood purification.PR Newswire 07.09.19
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Fist Assist Devices Announces Approval of FACT by University of Chicago Medical Center
Intermittent Compression Device clinical trial aims to prove vein dilation to improve fistula outcomes in patients with Stage 4 kidney disease.Business Wire 05.29.19
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Digital Health | Patient Monitoring | Software & IT
FDA Grants Breakthrough Device Designation to KidneyIntelX
Provides priority regulatory review of AI-enabled diagnostic for fast-progressing kidney disease.The Mount Sinai Hospital/Mount Sinai School of Medicine 05.06.19
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ExThera Medical Creates Scientific Advisory Board
Governing body created to advance the company’s global clinical trial program.Business Wire 04.23.19
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Fist Assist Devices Forms Global Medical Advisory Board
The board includes renowned leaders in the fields of vascular access and surgery.Business Wire 04.04.19
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Diagnostics
Early Detection, Home Monitoring Tests for Lupus Nephritis Under Development
Transformative research is empowering patients to monitor themselves.University of Houston 04.03.19
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Patient Monitoring
FDA OKs Masimo's Rad-67 Pulse CO-Oximeter
The cleared product touts next generation SpHb Spot-check Monitoring & rainbow DCI-mini Reusable Sensor.Business Wire 03.25.19
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Baxter Starts U.S. Clinical Trial for on-Demand Peritoneal Dialysis Solution System
The system designed to improve home dialysis experience and simplify therapy management.Business Wire 02.20.19
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Outset Medical Names New Members of Leadership Team
Dr. Michael Aragon and Stacey Porter bring wealth of clinical and organizational expertise during time of company growth.Business Wire 01.17.19
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AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
The device allows dialysis to be performed "on-the-go."PR Newswire 01.11.19
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Baxter and Mayo Clinic Partner to Establish Renal Care Center of Excellence in the U.S.
Project stems from five-year collaboration to advance care across different therapeutic areas.Business Wire 11.05.18
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Cardiovascular | Diagnostics | Patient Monitoring | Surgical
11 Finalists Selected for $100K Pediatric Medical Device Competition
This year’s competition focuses on pediatric cardiovascular devices, an area of significant need.Childrens National Health System 09.19.18
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Avenu Medical Receives FDA Approval for Ellipsys Vascular Access System
Endovascular arteriovenous fistula (endoAVF) technology approved for hemodialysis access.Business Wire 08.07.18
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Humacyte Appoints President and CEO
Long-time chairman and CEO is named executive chairman.Business Wire 07.31.18
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Surgical
BD Acquires TVA Medical to Advance Chronic Kidney Disease Solutions
TVA Medical's everlinQ endoAVF System also received FDA De Novo marketing authorization.PR Newswire 07.09.18
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Diagnostics
Mologic Signs Agreements with Medisur and Peripal to Distribute PERiPLEX POC Diagnostic in Europe
Point-of-care test for detection of infection in dialysis patients available in a half-dozen countries.Mologic Ltd. 06.05.18
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Diagnostics | Digital Health | Neurological
FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
The agency will work closely with selected applicants to accelerate product development.U.S. Food and Drug Administration 05.31.18
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CVS Enters Home Dialysis Market with New Device
Company's unique enterprise assets can help improve patient outcomes and control costs.CVS Health 04.06.18
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Cardiovascular
Secant Develops First Synthetic Regenerative Cardiovascular Graft
Supports regeneration of new vascular tissue structures without need for cell seeding or biologic growth promoters.Business Wire 01.16.18
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Surgical
FDA Approves Bard's Lutonix 035 DCB for Dysfunctional AV Fistulae Treatment
New option to preserve vascular access and help hemodialysis patients extend time between reinterventions.Business Wire 08.28.17
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Baxter Achieves Regulatory Milestone for New Peritoneal Dialysis Technology
New system may reduce barriers and offer more patients access to home therapy.Business Wire 05.18.17
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Cardiovascular
Studies Show Benefits of Flow Forward's Arteriovenous Fistula Eligibility System
Data validate the rapid rate of vein dilation during AFE System treatment.Business Wire 02.15.17
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CBSET Appoints Director of Research and Innovation
New executive will provide scientific direction to CBSET’s translational research programs.Business Wire 11.11.16
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CBSET Appoints Director of Business Development
New executive was co-owner of preclinical research organization Care Research.Business Wire 11.09.16
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R&D & Design | Software & IT
Baxter’s AMIA with SHARESOURCE Telehealth Platform Receives Innovation Award
Product is touted as the only medical device for home dialysis therapy with two-way telehealth platform.Business Wire 11.07.16
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Testing
FDA Clear's Teleflex's Arrow JACC with Chlorag+ard Technology and Tunneler
The device is a long-term, tunneled, small french size antithrombogenic and antimicrobial central venous catheter.Business Wire 10.10.16
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R&D & Design
Quintiles and DaVita Clinical Research Announce Strategic Alliance
Companies will work together to optimize renal disease trialsBusinesswire 08.03.16
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Software & IT
Baxter Attains Health Canada Approval of AMIA Automated Peritoneal Dialysis System
Canadian home dialysis patients to gain access to therapy with two-way connectivity with healthcare team.Business Wire 06.30.16
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Gore VIABAHN Endoprosthesis Found to Provide Superior Patency and Reduced Interventions
Study illustrates role device can play in maintaining and salvaging failing dialysis circuits.Business Wire 06.28.16
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Contract Manufacturing
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Fresenius Renal Therapies Introduces Next-Generation Sentinel Technology
Product supports fluid management challenges in the end stage renal disease community.Business Wire 05.04.16
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Materials
Fresenius Rebrands its Dialysis Division
Company claims name change better demonstrates its focus.Fresenius Medical Care 04.19.16
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Nephros Receives FDA Clearance for Point of Use Hemodialysis Machine Filter
Filter designed to protect patients from water-borne bacteria.Nephros Inc. 04.14.16
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NxStage Appeals to Medicare/Medicaid: Reconsider Changes to End-Stage Renal Disease Payment Plans
Company contends proposed change does not provide enough reimbursement for home hemodialysis training.09.06.13
