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Evaluations for the EU: The Impact on Testing & Lab Services
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DirectMed Imaging Acquires Titanium Medical Imaging
SetPoint Medical Receives FDA Breakthrough Device Designation
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Sequel's twiist Automated Insulin Delivery System Wins FDA OK
Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
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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
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
Hyperfine Rolls Out Update of its AI-Powered Brain Imaging Software
The eighth generation of the firm's Swoop system software has obtained CE and UKCA approval.
Michael Barbella, Managing 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
FDA Clears Cosm Medical’s Gynethotics Pessaries
The new product offers almost 10 million configurations that can be ordered by clinicians online.
Sean Fenske, Editor-in-Chief
03.15.24
Benjamin Bishop Named CEO of Spirair
He’s gained experience within medtech at firms including Revelle Aesthetics, Revance Therapeutics, and Access Closure.
Sean Fenske, Editor-in-Chief
03.14.24
Two Infant Monitoring Devices Released to Market
Dream Sock and BabySat measure oxygen saturation and pulse rate.
Michael Barbella, Managing Editor
03.14.24
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
Integra LifeSciences Releases MicroMatrix Flex in the US
This system includes a flexible tip to deliver flowable Urinary Bladder Matrix (UBM) technology.
Rachel Klemovitch, Assistant Editor
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
electroCore Expands Intellectual Property Portfolio
Two new patents relate to the company’s non-invasive vagus nerve stimulation technology.
Michael Barbella, Managing Editor
03.12.24
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
View More >