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Search Results for '
hemodialysis
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Chronic Disease
FDA OKs Fresenius Medical Care's 5008X Hemodialysis System
5008X’s high-volume hemodiafiltration uses both diffusion and convection to remove large and small molecules from the blood.
Sam Brusco, Associate Editor
02.09.24
Diality to Conduct Study of its Moda-flx Home Hemodialysis System
First patient enrollments are expected this quarter.
Michael Barbella, Managing Editor
01.26.24
Trace Medical, Outset Medical Team Up to Distribute the Tablo Hemodialysis System
New collaboration will help drive access for home medical equipment providers to first-of-its kind technology for home dialysis.
Michael Barbella, Managing Editor
12.06.23
Rockwell Medical Buys Hemodialysis Concentrates Business From Evoqua
The $16 million deal significantly expands Rockwell Medical's geographic footprint, customer base, and product offerings.
Michael Barbella, Managing Editor
09.11.23
Cardiovascular
Medtronic (Covidien) Hemodialysis Catheter Recall is Class I
Palindrome and Mahurkar catheters recalled over risk of leakage due to hub defect.
Sam Brusco, Associate Editor
08.22.22
Chronic Disease
FDA Warns of Toxic Risk from Fresenius Hemodialysis Machines
NDL PCBA, NDL PCB compounds found in silicone tubing in hydraulics and dialysate lines.
Sam Brusco, Associate Editor
05.10.22
Chronic Disease
FDA OKs Baxter's AK 98 Hemodialysis Machine
Can be used alongside Theranova, Baxter’s novel dialysis membrane.
Sam Brusco, Associate Editor
03.15.21
First Human Trial Begins for Contactless Hemodialysis Imaging Surveillance System
Trial to provide initial experiences in fistula surveillance for early detection and prediction of fistula stenosis.
Michael Barbella, Managing Editor
03.09.21
FDA Clears a Portable Hemodialysis System
Quanta Dialysis Technologies' SC+ system became available in the U.K. last year.
Michael Barbella, Managing Editor
01.26.21
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
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
FDA OKs Outset's Table System for Home Dialysis
First new device cleared for home hemodialysis in 15 years.
PR Newswire
04.02.20
Increase in Dialysis Centers to Drive Renal Dialysis Machines Market
Sector is expected to grow 3.2 percent annually over the next eight years.
GlobalData
03.03.20
Cardiovascular
Enrollment Complete in Trial of Arteriovenous Fistula Support Device
VasQ is intended to promote usability of both forearm and upper arm fistulas.
Videos
Business Wire
Study: New Approach to Dialysis Access Leads to High Patient Satisfaction
Significant success rates reported in patients who had their fistulas created with the Ellipsys Vascular Access System.
Videos
Access Solutions
Patient Monitoring
SunTech Medical and Valencell Collaborate
Plan to develop new blood pressure measurement solutions.
Newswire
01.27.20
Cardiovascular
Concept Medical Granted CE Certification for its Sirolimus Coated MagicTouch Group of Products
Company is now focused on marketing the products in Europe.
Businesswire
11.25.19
Medtronic Drug-Coated Balloon Approved by FDA
Designed to treat arteriovenous fistula lesions.
Medtronic plc.
11.22.19
Concept Medical Granted FDA Breakthrough Device Designation for Sirolimus Coated Balloon
The MagicTouch AVF Sirolimus Coated Balloon Catheter is indicated for use in percutaneous transluminal angioplasty.
Newswire.com
10.14.19
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
Cardiovascular
|
Surgical
Concept Medical's Magic Touch AVF Sirolimus Coated Balloon Granted Breakthrough Status
Magic Touch AVF treats stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure.
PR Newswire
08.30.19
6. BD
...
07.30.19
10. Baxter
...
07.30.19
15. B. Braun
...
07.30.19
17. Fresenius
...
07.30.19
COSTAS Inc. Acquires Medical Nanotechnology Company
New management and board members appointed.
Globe Newswire
07.24.19
Outset Medical Appoints New Chief Financial Officer
Former Illumina executive joins Outset as company scales to meet demand.
Business Wire
07.24.19
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
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
Insera Earns CE Mark Approval for Cyclical-suction Stroke Thrombectomy Platform
Approval was based on mechanical bench tests, safety and efficacy tests conducted in premier stroke device testing centers.
Business Wire
05.24.19
Cardiovascular
PAVmed Announces PortIO Breakthrough
Implantable intraosseous vascular access device achieves unprecedented maintenance-free implant duration of over 60 days in pre-clinical testing.
Globe Newswire
04.24.19
B. Braun Medical Acquires NxStage Medical Inc.’s Streamline Bloodlines
The Streamline Bloodlines adds to the integrated line of dialysis products B. Braun’s Avitum division currently offers.
Globe Newswire
04.08.19
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
NxStage Must Divest Bloodline Tubing Biz to B. Braun to Complete Fresenius Merger
FTC’s complaint alleges the proposed merger would harm competition in the U.S. market for dialysis bloodline tubing sets.
Federal Trade Commission (FTC)
02.20.19
Cardiovascular
Cardiovascular Systems Receives Japanese Approval for Diamondback 360 Coronary System
Regulators okay system with Classic Crown and new ViperWire Advance FlexTip Guidewire.
Business Wire
02.12.19
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
Modern Predicates Can Promote Innovation, Advance Safety and Effectiveness of 510(k)-Cleared Devices
In the coming months, you’ll hear more from the FDA about the use of older predicates.
Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration
11.28.18
Diagnostics
|
Surgical
Past Dues: Medtech's 2018 Year in Review
The industry confronted old ghosts in 2018 as it defended itself against a documentary and crammed for regulatory changes.
Michael Barbella, Managing Editor
11.26.18
Electronics
5 Questions from the Booth: Humphrey Products Company
Optimizing fluid handling and pneumatic control for shrinking medical devices that are moving closer to patients.
MPO Staff
11.12.18
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
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
Outset Medical Raises $132 Million to Accelerate Expansion of its Tablo Hemodialysis System
Technology is designed to reduce the cost and complexity of dialysis and transform patient care.
Outset Medical
08.30.18
Avenu Medical Receives FDA Approval for Ellipsys Vascular Access System
Endovascular arteriovenous fistula (endoAVF) technology approved for hemodialysis access.
Business Wire
08.07.18
Humacyte Appoints President and CEO
Long-time chairman and CEO is named executive chairman.
Business Wire
07.31.18
10. Baxter International
...
07.26.18
B. Braun to Acquire Bloodlines Business of NxStage Medical
Deal contingent upon the closing of the pending merger of NxStage with a subsidiary of Fresenius Medical Holdings.
B. Braun Medical
07.23.18
ExThera Medical Completes CE Mark Trial Evaluating the Safety of Seraph 100 Blood Filter
Trial provides foundation for company’s submission for European CE Mark application.
Business Wire
07.20.18
Second Major Study Demonstrates Superiority of ClearGuard HD Antimicrobial Barrier Caps
The study’s primary outcome was the number of positive blood cultures as an indicator of BSI rate.
Pursuit Vascular Inc.
07.18.18
FDA Broadens ClearGuard HD Antimicrobial Barrier Cap Indications
Caps have been shown to reduce central line-associated bloodstream infections in hemodialysis patients.
PR Newswire
07.11.18
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
Breaking News
ISO 13485 Certification Awarded to Scherdel Medtec North America
FDA Clears AIOMEGA’s Sleep Apnea Treatment Solution
Empatica Initiates AI Seizure Forecasting Study With Debut of Epilepsy Watch
Enrollment Complete in Study of FIRE1's Remote Heart Failure Monitoring System
Medtronic Releases Avalus Ultra Surgical Aortic Tissue Valve
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