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Neurological
SetPoint Medical Receives FDA Breakthrough Device Designation
The neuroimmune modulation platform promotes remyelination for those with relapsing-remitting multiple sclerosis.
Rachel Klemovitch, Assistant Editor
03.18.24
Diagnostics
Siemens Healthineers to Close Fast Track Diagnostics Biz
The company said demand for Fast Track Diagnostics' portfolio has dropped significantly since the peak of the COVID-19 pandemic.
Sam Brusco, Associate Editor
03.18.24
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
Cardiovascular
Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
The Freesolve BTK RMS is designed for patients with chronic limb-threatening ischemia (CLTI).
Sam Brusco, Associate 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
Surgical
Titan Medical to Merge with Conavi Medical
The combined company will continue to commercialize Conavi’s Novasight Hybrid system.
Sam Brusco, Associate Editor
03.18.24
Chronic Disease
|
Digital Health
Welldoc's BlueStar Mobile App Earns EU Nod
The solution guides people through living with diabetes using personalized, AI-driven digital coaching and insights
Sam Brusco, Associate Editor
03.18.24
SeaStar Medical's Selective Cytopheretic Device Now Patented for Multiple Uses
The newly issued U.S. patent covers methods for using SCD cartridges to treat inflammatory conditions.
Michael Barbella, Managing Editor
03.18.24
Surgical
FDA OKs Intuitive's Next-Gen da Vinci 5 Surgical Robot
The surgical robot includes Force Feedback technology and instruments.
Sam Brusco, Associate Editor
03.18.24
Five Finalists Compete in Pediatric Device Innovation Pitch
Up for grabs is $50,000 in potential awards for pediatric medical devices created by Hispanic and African American innovators.
Michael Barbella, Managing Editor
03.15.24
Two Infant Monitoring Devices Released to Market
Dream Sock and BabySat measure oxygen saturation and pulse rate.
Michael Barbella, Managing Editor
03.14.24
Neurological
Wrist Device Could Give Early Alzheimer’s Warning
The technology monitors activity in older adults and detects differences between those with brain amyloid buildup and those without.
Sean Fenske, Editor-in-Chief
03.14.24
Digital Health
New Intelligent Automation Tech Significantly Cuts Clinical Trial Deployment Time
AI-powered platform takes electronic clinical outcomes assessment off the critical path to study startup for life sciences industry.
Michael Barbella, Managing Editor
03.14.24
Diagnostics
A Look at Micro-X’s Mobile Stroke Diagnosis Device
The unit is designed to fit within an ambulance where a patient can be assessed and diagnosed while en route to the hospital.
Videos
Sean Fenske, Editor-in-Chief
What’s New with Reprocessing Validations for Reusable Medical Devices
Register Now for Our FREE Webinar on April 17, 2024; 1PM EST!
03.13.24
Surgical
Getinge Launches Corin OR Table and Ezea Surgical Light
Getinge highlighted these technologies at the AORN Conference 2024.
Rachel Klemovitch, Assistant Editor
03.13.24
Cardiovascular
FDA Approves Expanded Labeling of Barostim
U.S. annual market opportunity increases based on real-world adoption and strength of long-term BeAT-HF data.
Michael Barbella, Managing Editor
03.12.24
Diagnostics
Portable Crackle and Wheeze Detection Device Launched
The ChestPal Pro is a Bluetooth-connected, next generation smart stethoscope available in the U.S.
Sean Fenske, Editor-in-Chief
03.12.24
Digital Health
Intelligent Scopes, Mayo Clinic Team Up on AI-Based Urologic Solutions
Collaboration aims to deliver software tools that help urologists with disease detection, surgery, and post-treatment surveillance.
Michael Barbella, Managing Editor
03.11.24
Cardiovascular
Japan's Transcatheter Aortic Valve Replacement Market to Reach $820M in 2033
An aging population, new device approvals, and patient preference for MI procedures are helping drive the country's TAVR market.
Michael Barbella, Managing Editor
03.11.24
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
Researchers Develop Prototypes for Sensitive Skin Applications
Groups have developed an infant mattress for the ICU and a pressure sensor system for paraplegics.
Sean Fenske, Editor-in-Chief
03.11.24
Digital Health
KARL STORZ Releases CollaboratOR 3D App for Apple Vision Pro
The technology enables healthcare professionals to be immersed into 3D-based content from 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
Former Medical Device Company CEO Convicted of Selling Fake Components
Laura Perryman has been found guilty on two counts for Stimwave’s creation and sale of a fake component that was implanted in patients.
Rachel Klemovitch, Assistant Editor
03.08.24
Cardiovascular
Bodyport Announces New Data from its SCALE-HF 1 Study
Bodyport's heart failure monitoring technology detected twice as many heart failure events compared to the weight-based standard of care.
Rachel Klemovitch, Assistant Editor
03.08.24
Chronic Disease
Insulet's Omnipod 5 Outperforms Standard Insulin Pump Therapy
Data showed that using Omnipod 5 led to a 17.5% improvement in time in range.
Sam Brusco, Associate Editor
03.08.24
Neurological
Medtronic Has a Class I Catheter Tubing Recall
Medtronic recalled its Duet EDMS catheter tubing due to the risk of disconnection from patient line stopcock connectors.
Sam Brusco, Associate Editor
03.08.24
Cardiovascular
Getinge Wins FDA Nod for Vasoview Hemopro 3 Endoscopic Vessel Harvesting
New features include enhanced smoke evacuation, regulated energy control, a game controller-styled handle, and an integrated cable.
Sam Brusco, Associate Editor
03.08.24
Digital Health
|
Surgical
Seizing Strategic Opportunities in the Medtech Market
Strategies that medtech companies and manufacturers can use to advance in the medtech market.
Online Exclusives
Kyle Forcier, Senior Director of Services Sales at Model N
03.07.24
Surgical
Siemens Healthineers Releases Cinematic Reality App for Apple Vision Pro
The app allows healthcare professionals and students to interact with realistic renderings of the human anatomy.
Rachel Klemovitch, Assistant Editor
03.07.24
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
Cardiovascular
HeartBeam Granted Two More U.S. Patents
The company now has 14 issued and allowed U.S. patents and four international patents for its VECG technology.
Sam Brusco, Associate Editor
03.07.24
Cardiovascular
Thubrikar Wins Authorization to Expand the TAVI-1 CE Mark Trial in Poland
At less than half the height of commercial self-expanding platforms, the Optimum TAV allows full coronary access.
Michael Barbella, Managing Editor
03.07.24
Chronic Disease
|
Patient Monitoring
Abbott's Real-World Data Backs FreeStyle Libre CGM Use with GLP-1s
People with Type 2 diabetes had a greater HbA1c reduction when using GLP-1 drugs and FreeStyle Libre tech together.
Sam Brusco, Associate Editor
03.06.24
Cardiovascular
Endotronix Boasts Positive Data for Cordella Pulmonary Artery Sensor
The company's PROACTIVE-HF trial met its primary endpoints at six months.
Sam Brusco, Associate Editor
03.06.24
Cardiovascular
Gradient Starts U.S. Pulmonary Artery Denervation Trial
The Gradient Denervation system ablates nerves around the pulmonary artery using therapeutic ultrasound.
Sam Brusco, Associate Editor
03.06.24
Rapid Medical Wins Japanese Approval for TIGERTRIEVER Device
The product is engineered to activate clot integration and protect the vessel from injury in ischemic stroke procedures.
Michael Barbella, Managing Editor
03.06.24
Electronics
Driving Drug Delivery Devices with Miniature Motors—A Medtech Makers Q&A
When delivering life critical drugs, it is wise to work with an experienced drive assembly supplier.
Chronic Disease
|
Patient Monitoring
FDA Clears Dexcom's Stelo, the First Over-the-Counter CGM
Stelo offers an option for those who don’t have insurance coverage for CGM.
Sam Brusco, Associate Editor
03.05.24
Surgical
EDAP Receives FDA Breakthrough Device Designation for Focal One
Focal One Robotic Focal HIFU gains Breakthrough Device designation for deep infiltrating endometriosis.
Rachel Klemovitch, Assistant Editor
03.05.24
Diagnostics
Beckman Coulter's DxFLEX Clinical Flow Cytometer Gets FDA OK
The clearance beings the benchtop IVD flow cytometry system to American labs.
Sam Brusco, Associate Editor
03.05.24
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
Cardiovascular
Getinge CE Certificate for Cardiosave is Temporarily Suspended by TÜV SÜD
Getinge has been given six months to fulfill corrective conditions for the Cardiosave Intra-Aortic Balloon Pump.
Rachel Klemovitch, Assistant Editor
03.05.24
Study: DermaSensor Device Significantly Increases Skin Cancer Detection
Data indicate physicians’ referral of skin cancer increased from 81% to 94%.
Michael Barbella, Managing Editor
03.05.24
Cardiovascular
BD Begins AGILITY IDE Trial for Vascular Covered Stent
The AGILITY IDE study will assess BD's Vascular Covered Stent to treat peripheral arterial disease.
Sam Brusco, Associate Editor
03.05.24
Cardiovascular
Haemonetics to Buy Attune Medical for $160 Million
Attune Medical is the maker of the ensoETM proactive esophageal cooling device.
Sam Brusco, Associate Editor
03.05.24
Diagnostics
Philips and Synthetic MR Partner for AI-based Brain Imaging Technology
The Smart Quant Neuro 3D advances neurology care for patients with combined technology from Philips and Synthetic MR.
Rachel Klemovitch, Assistant Editor
03.04.24
Diagnostics
Royal Philips Launches New AI-Enabled CT 5300
This new system provides more accurate and reliable imaging results.
Rachel Klemovitch, Assistant Editor
03.04.24
Breaking News
DirectMed Imaging Acquires Titanium Medical Imaging
SetPoint Medical Receives FDA Breakthrough Device Designation
Siemens Healthineers to Close Fast Track Diagnostics Biz
Sequel's twiist Automated Insulin Delivery System Wins FDA OK
Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
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