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Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
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Device Sectors
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Digital Health
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards—Mike on Medtech
Mike Drues and Sean Fenske look at the medtech-centric items on the list and discuss why they are a concern.
Sean Fenske, Editor-in-Chief
03.19.24
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
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
Packaging & Sterilization
EPA’s Final EtO Rule: Cut Emissions by 90%
Rule allows for a two-year compliance exemption to be issued to prevent shortages in the medical device supply chain.
Sean Fenske, Editor-in-Chief
03.14.24
Molding
Plastics News Names 2023 Processor of the Year
PTI Engineered Plastics won the award, beating out two other finalists that were named in January 2024.
Sean Fenske, Editor-in-Chief
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
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
Testing
SGS Laboratory Earns ISO/IEC 17025:2017 Certification
Location in Fairfield, N.J. gains accreditation for its chemical and in vitro cytoxicity testing capabilities.
Sean Fenske, Editor-in-Chief
03.11.24
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 >