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Endologix Examining Real-World Performance of its DETOUR System
PTAB1 study will enroll up to 450 subjects, with a focus on including at least 200 women.
Michael Barbella, Managing Editor
04.24.24
Cardiovascular
Enrollment Complete in Study of FIRE1's Remote Heart Failure Monitoring System
The FIRE1 system is a small, minimally invasive implantable sensor designed to accurately identify fluid volume build-up earlier.
Michael Barbella, Managing Editor
04.23.24
Surgical
Watching the Robotic Surgical System Evolution in Real Time
Depending on the study you read, the differences between robotic surgery and laparoscopic procedures are negligible.
Sean Fenske, Editor-in-Chief
04.22.24
Cardiovascular
|
Neurological
Expanse ICE Aspiration Catheter System Wins FDA Nod
Expanse ICE harnesses the aspiration power found in a large bore catheter, in the slender profile of a much smaller device.
Sam Brusco, Associate Editor
04.22.24
First Clinical Trial Patient Treated With Pulmonx's AeriSeal System
The AeriSeal System shows promise in limiting collateral ventilation.
Michael Barbella, Managing Editor
04.22.24
Chronic Disease
|
Diagnostics
Lumicell's Breast Cancer Visualization System Wins FDA Approval
LumiSystem allows scanning the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer.
Sam Brusco, Associate Editor
04.19.24
Wearable Neuromodulation System for Urinary Incontinence Makes its Debut
Avation Medical’s Vivally System eliminates the need for surgery, drugs, and needles.
Michael Barbella, Managing Editor
04.17.24
Cardiovascular
Getinge Gains EU MDR Approval for Advanta V12 Covered Stent System
Advanta V12 is designed for patients with aortoiliac occlusive disease, including lesions at the aortic bifurcation.
Rachel Klemovitch, Assistant Editor
04.11.24
Diagnostics
Siemens Healthineers Wins FDA Nod for New Mammography System
Mammomat B.brilliant is the first completely redesigned mammography platform in over ten years, the company said.
Sam Brusco, Associate Editor
04.05.24
Neurological
Silk Road Medical Launches ENROUTE Transcarotid Neuroprotection System PLUS
The NPS PLUS is the latest addition to Silk Road’s TCAR portfolio and is built on the prior ENROUTE Transcarotid Neuroprotection System.
Rachel Klemovitch, Assistant Editor
04.04.24
Inspire Medical Systems Losing Longtime Board Member
Jerry C. Griffin has been part of the governing body since 2008.
Michael Barbella, Managing Editor
04.02.24
Diagnostics
Olympus and NTT Start World’s First Demonstration Experiment of Cloud Endoscopy System
The two companies will create a reference model for a cloud endoscopy system that enables real-time image processing of endoscopes on the cloud.
Rachel Klemovitch, Assistant Editor
03.27.24
Calyxo Gets FDA OK for Redesigned CVAC System
The company's CVAC system allows a minimally invasive approach for treating kidney stones.
Sam Brusco, Associate Editor
03.26.24
Neurological
|
Surgical
NeuroOne Begins Limited Rollout of OneRF Ablation System
The FDA-cleared thin-film, sEEG-guided RF system can both record electrical activity and ablate nervous tissue.
Sam Brusco, Associate Editor
03.26.24
Envoy Medical Nabs Three Patents for Implantable Cochlear Systems
Company's fully implanted technology features a sensor designed to leverage the ear's natural anatomy rather than a microphone to capture sound.
Michael Barbella, Managing Editor
03.26.24
Diagnostics
Siemens Healthineers Develop Self-Driving Automated C-Arm System
Ciartic Move is remote-controlled with 50% faster intraoperative imaging.
Rachel Klemovitch, Assistant Editor
03.21.24
CE Mark Granted to Reflow Medical's Bare Temporary Spur Stent System
Product treats below-the-knee lesions using stent therapy without the risk of stent implants.
Michael Barbella, Managing Editor
03.21.24
Cardiovascular
Elixir Medical Wins Breakthrough Nod for DynamX Below-the-Knee System
The adaptive implant treats chronic limb-threatening ischemia resulting from below-the-knee arterial disease.
Sam Brusco, Associate Editor
03.21.24
Shawn McCarrey Named Chief Commercial Officer at BioStem Technologies
New executive most recently held the same title at BLUEWAVE.
Michael Barbella, Managing Editor
03.20.24
Surgical
MMI Joins Forces With ab medica to Expand Symani Surgical System Access
ab medica will enhance MMI’s visibility across Italy and expand provider and patient access to microsurgical robotic technology.
Michael Barbella, Managing Editor
03.19.24
Chronic Disease
Sequel's twiist Automated Insulin Delivery System Wins FDA OK
twiist is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose.
Sam Brusco, Associate Editor
03.18.24
HistoSonics' IDE Study of the Edison System Now Underway
FIrst histotripsy treatment performed in central Florida.
Michael Barbella, Managing Editor
03.18.24
Neurological
Axonics Gets CE Mark for R20 Rechargeable Sacral Neuromod System
Axonics plans to begin R20 sales to European customers in mid-April.
Sam Brusco, Associate Editor
03.18.24
CE Mark Granted to iRhythm Technologies' Zio Monitor and ZEUS System
The new Zio monitor is thinner, lighter, and smaller compared to Zio XT to provide a more inconspicuous wear experience.
Michael Barbella, Managing Editor
03.13.24
Surgical
Pulse Biosciences Gains 510(k) Clearance for Percutaneous Electrode System
The CellFX nsPFA is used in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
Sean Fenske, Editor-in-Chief
03.11.24
Patient Monitoring
RDS Secures CE Mark for its MultiSense Remote Patient Monitoring System
The MultiSense wearable solution receives a class IIa medical device certification, in compliance with Regulation (EU) 2017/745.
Rachel Klemovitch, Assistant Editor
03.08.24
Cardiovascular
Silk Road Medical Launches Tapered ENROUTE Transcarotid Stent System
The expansion to the TCAR Portfolio offers additional configurations to tailor the TCAR procedure to patient anatomy.
Rachel Klemovitch, Assistant Editor
03.07.24
Align Technology Gains Updated Canadian License for Invisalign Palatal Expander System
Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution.
Michael Barbella, Managing Editor
03.06.24
Cardiovascular
|
Diagnostics
|
Software & IT
Cleerly's Coronary Artery Disease Staging System Granted Breakthrough Status
The Cleerly CAD staging system was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot.
Sam Brusco, Associate Editor
03.05.24
Cardiovascular
|
Patient Monitoring
FDA Clears ADI's Sensinel Cardiopulmonary Management System
The compact, wearable device captures cardiopulmonary measurements to manage chronic conditions like heart failure.
Sam Brusco, Associate Editor
03.05.24
Chronic Disease
Varian's HyperSight Imaging OK'ed for TrueBeam & Edge Radiotherapy Systems
HyperSight allows acquisition of high-quality images during a daily course of radiation treatments.
Sam Brusco, Associate Editor
02.29.24
Diagnostics
|
Neurological
ECR2024: Philips Launches Azurion Neuro Biplane System
New features include enhanced C-arm rotation, angulation, and parking facilities for rapid transition between 2D and 3D imaging.
Sam Brusco, Associate Editor
02.27.24
Surgical
Virtual Incision Gains FDA Authorization for its MIRA Surgical System
MIRA miniaturized robotic-assisted surgery device challenges industry standards in soft tissue robotic-assisted surgery.
Rachel Klemovitch, Assistant Editor
02.26.24
FDA Clears Beckman Coulter Life Sciences' AQUIOS STEM System
Product provides United States with first workflow update in 25 years.
Michael Barbella, Managing Editor
02.23.24
Bayer and CrossBay Medical to Develop Intrauterine System Inserter
New inserter has the potential to improve intrauterine placement.
Michael Barbella, Managing Editor
02.22.24
ENDRA Life Sciences Secures 39th U.S. Patent for TAEUS System Technology
Company's intellectual property portfolio now stands at 71 globally issued patents.
Michael Barbella, Managing Editor
02.21.24
Double-Digit Growth Forecast for China's Robotic Surgical Systems Market
J&J’s new Monarch Platform last fall was the company's first robotic-assisted technology to be approved in China.
Michael Barbella, Managing Editor
02.20.24
Carestream Introduces Digital-Ready HORIZON X-Ray System
The new system features a floating tabletop that allows fast positioning and flexibility for all major exams.
Michael Barbella, Managing Editor
02.14.24
Calyxo Releases Positive Study Data for CVAC Aspiration System
Trial concluded the CVAC Aspiration System is safe and effective for treating large kidney stones.
Michael Barbella, Managing Editor
02.12.24
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
Implantable Cochlear Systems Patent Granted to Envoy Medical
Company's Acclaim Cochlear Implant received FDA Breakthrough Device Designation in 2019.
Michael Barbella, Managing Editor
02.06.24
Hologic Receives FDA Clearance for Genius Digital Diagnostics System
First FDA-cleared digital cytology system.
Rachel Klemovitch, Assistant Editor
02.05.24
Ken Miller Named Chief Commercial Officer at KORU Medical Systems
New executive has over 30 years of extensive healthcare expertise and experience.
Michael Barbella, Managing Editor
02.05.24
FDA Clears KORU Medical's FREEDOM60 Infusion System With Prefilled Syringes
Company claims the FREEDOM Infusion System is the first and only such system cleared for use with prefilled syringes.
Michael Barbella, Managing Editor
01.30.24
908 Devices, Terumo BCT Adding On-line Analytics to Quantum Flex Cell Expansion System
Automation combined with on-line monitoring during the cell expansion step can bring cell therapy manufacturing efficiencies.
Michael Barbella, Managing Editor
01.29.24
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
Cardiovascular
Surmodics Announces the Clinical Use of Pounce LP Thrombectomy System
The platform allows for efficient clot removal of thrombi and emboli below the knee.
Rachel Klemovitch, Assistant Editor
01.23.24
Chronic Disease
Scientist Creates New Drug Delivery System
Wireless drug patch features electronically triggered micro-needles for on-demand drug delivery.
Rachel Klemovitch, Assistant Editor
01.22.24
Microbot Medical Releases Promising Study Data for the LIBERTY Robotic System
Follow-up visual examination three days after the procedures shows 100% success rate and no adverse events.
Michael Barbella, Managing Editor
01.19.24
Study: Paradise Ultrasound Renal Denervation System Helps Reduce Blood Pressure
Data show a maintained blood pressure lowering effect with fewer added medications after using Recor Medical's Paradise uRDN system.
Michael Barbella, Managing Editor
01.18.24
Breaking News
Teleflex Marks Opening of Expanded Manufacturing Facility
Endologix Examining Real-World Performance of its DETOUR System
FDA Clears First Digital Therapeutic for Postpartum Depression
Syed Faridi Joins Catawba Research as Business Development Head
Penumbra's Next-Gen Computer-Assisted Vacuum Thrombectomy Wins FDA Nod
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
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