Login
Join
FOLLOW:
Subscribe Free
Magazine
eNewsletter
Checkout
Menu
Magazine
News
Opinions
Top 30
Research
Supply Chain
Device Sectors
Directory
Events
Resources
Microsites
More
Magazine
News
Opinions
Top 30
Research
Supply Chain
Device Sectors
Directory
Events
Resources
Microsites
Current / Back Issues
Features
Editorial
Digital Edition
eNewsletter Archive
Our Team
Editorial Guidelines
Reprints
Subscribe Now
Advertise Now
Top Features
Superior Subtractive Solutions for Machining Medtech
Assembly & Automation Experts Share Thoughts on Medtech Trends
Power Trip: A Discussion of Custom Medical Electronics
The MDR Transition: An Opportunity for Design Change?
Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
OEM News
Supplier News
Service / Press Releases
Online Exclusives
Press Releases
People in the News
Product & Service Releases
Supplier News
Medtech Makers
Technical Features
International News
Videos
Product & Service Releases
Live From Shows
Regulatory
Financial/Business
Top News
Beckman Coulter Helping Labs Comply With Annex 1 Regulation
FDA Clears MeMed BV Direct From Whole Blood
Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
Abbott Completes Acquisition of Bigfoot Biomedical
From the Editor
Blogs
Guest Opinions
Top Opinions
Superior Subtractive Solutions for Machining Medtech
Assembly & Automation Experts Share Thoughts on Medtech Trends
Power Trip: A Discussion of Custom Medical Electronics
The MDR Transition: An Opportunity for Design Change?
Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
Top 30 Medical Device Companies
Market Data
White Papers
Top Research
Medtech’s Most Powerful M&A Drivers
The Link Between Medtech and Connected Medical Devices
Is the FTC Partly Responsible for Muted M&A Activity?
Holistic Risk Management: Navigating the Future’s Uncertainties
Defining End of Life for Medical Devices
3D/Additive Manufacturing
Contract Manufacturing
Electronics
Machining & Laser Processing
Materials
Molding
Packaging & Sterilization
R&D & Design
Software & IT
Testing
Tubing & Extrusion
Cardiovascular
Diagnostics
Digital Health
Neurological
Patient Monitoring
Surgical
Orthopedics
All Companies
Categories
Company Capabilities
Add New Company
Outsourcing Directory
Cirtec Medical
Arthur G. Russell Co. Inc., The
Providence Enterprise USA Inc.
Johari Digital Healthcare Ltd.
Halkey-Roberts Corporation
MPO Summit
Industry Events
Webinars
Live From Show Event
Industry Associations
Videos
Career Central
eBook
Slideshows
Top Resources
A One-Stop-Shop, Turnkey Solution Is Paramount for Success
How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry
Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
How In Silico Simulations Can Slash Medical Device Development Risk
The Top 7 AI Applications Transforming Medical Device Manufacturing
Companies
News Releases
Product Releases
Press Releases
Product Spec Sheets
Service Releases
Case Studies
White Papers
Brochures
Videos
Outsourcing Directory
Cirtec Medical
Arthur G. Russell Co. Inc., The
Providence Enterprise USA Inc.
Johari Digital Healthcare Ltd.
Halkey-Roberts Corporation
Magazine
Current/Back Issues
Features
Editorial
Columns
Digital Editions
Subscribe Now
Advertise Now
News
Directory
All Companies
ALL CATEGORIES
Industry Associations
Company Capabilities
Add Your Company
Supply Chain
3D/Additive Manufacturing
Contract Manufacturing
Electronics
Machining & Laser Processing
Materials
Molding
Packaging & Sterilization
R&D & Design
Software & IT
Testing
Tubing & Extrusion
Device Sectors
Cardiovascular
Diagnostics
Digital Health
Neurological
Patient Monitoring
Surgical
Orthopedics
Top 30 Company Report
Expert Insights
Slideshows
Videos
eBook
Resources
Podcasts
Infographics
Whitepapers
Research
White Papers
Case Studies
Product Spec Sheets
Market Data
MPO Summit
Events
Industry Events
Live From Show Events
Webinars
Microsite
Companies
Product Releases
Product Spec Sheets
Services
White Papers / Tech Papers
Press Releases
Videos
Literature / Brochures
Case Studies
About Us
About Us
Contact Us
Advertise with Us
eNewsletter Archive
Privacy Policy
Terms of Use
Regulatory
All News
Financial & Business News
International News
MPO Movers
OEM News
People
Regulatory
Supplier News
FDA Clears MeMed BV Direct From Whole Blood
Allows clinicians to more rapidly distinguish bacterial from viral infections.
Michael Barbella, Managing Editor
09.22.23
Digital Health
Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech
The video analytics feature uses edge computing to monitor patients and hospital spaces for movement and voice cues, transferring metadata 24/7.
Michael Barbella, Managing Editor
09.21.23
South Korean Regulators Authorize Expanded NeuroStar TMS Indications
Approval is the first international consent for expanded indication and certification for MT Cap and D-Tect technologies.
Michael Barbella, Managing Editor
09.21.23
FDA Approves IDE Use of ExThera Medical's OncoBind Extracorporeal Procedure
The blood filtration procedure removes circulating tumor cells in pancreatic cancer patients.
Michael Barbella, Managing Editor
09.19.23
FDA Approves Urotronic's BPH Catheter System
The company won FDA approval for Optilume after running a clinical trial that compared the device to a sham treatment in 148 patients.
Michael Barbella, Managing Editor
09.18.23
FDA Approves IDE Trial of Verve Medical's Treatment for Uncontrolled Hypertension
Company's Renal Pelvic Denervation System showed a 20.3 mm Hg reduction in blood pressure and a 12-month durability.
Michael Barbella, Managing Editor
09.14.23
Pearl's Second Opinion AI Platform Granted EU-MDR Certification
Flagship solution is the first and only AI-based dental pathology detection software to be certified as a Class IIa medical device under EU-MDR.
Michael Barbella, Managing Editor
08.23.23
Canadian Regulators Approve FemCath Intrauterine Catheter
Product is the first intrauterine catheter that allows clinicians to selectively evaluate a fallopian tube with natural saline and air contrast.
Michael Barbella, Managing Editor
08.17.23
Cardiovascular
FDA Clears Tractus Vascular's Tunnel Crossing Catheter
The company's Jigsaw Technology shaft offers high buckle resistance, yielding superior pushability across difficult occlusions.
Michael Barbella, Managing Editor
08.17.23
Cardiovascular
FDA Clears Sparrow’s Smartphone Stethoscope
Breakthrough SaaMD enables smartphones to be used as stethoscopes that capture, analyze, and share cardiovascular and pulmonary sound data.
Michael Barbella, Managing Editor
08.14.23
Cardiovascular
Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
The company recalled the IABPs over unexpected shutdown due to electrical failures in their power management or solenoid boards.
Sam Brusco, Associate Editor
08.10.23
CE Mark Approval Granted to Establishment Labs' MI Surgical Tools
The Motiva Channel Dissector, Balloon, and Injector are designed to be used in next-generation minimally invasive aesthetic procedures.
Michael Barbella, Managing Editor
08.07.23
Cardiovascular
FDA Grants Breakthrough Device Designation to Pulse Medical's μFR System
The angio-based physiological assessment tool has no pressure wire or hyperemic agents.
Michael Barbella, Managing Editor
08.07.23
Health Canada Approval Granted for COVID-19 Treatment With Near Infrared Light
Device is intended for COVID-19 patients who experience acute symptoms within seven days of symptom onset.
Michael Barbella, Managing Editor
08.03.23
Montrose Environmental, Thermo Fisher Partner on EtO Solution
Recent EPA regulations aim to reduce ethylene oxide emissions from chemical plants and commercial sterilizers.
Michael Barbella, Managing Editor
07.25.23
FDA Grants Expanded Pediatric Indication for Orchid Safety Release Valve
Linear Health's device is intended to reduce the risk of IV catheter failure and replacement in hospitals.
Michael Barbella, Managing Editor
07.19.23
Digital Health
Wellthy Therapeutics Secures FDA, HIPAA Certification for SaMD Platform
The platform is already compliant with EU MDR Class 1, ISO 13485, ISO 27001, ISO 27701, IEC 62304, and GDPR.
Michael Barbella, Managing Editor
07.17.23
Neuronetics Granted MDSAP, CE Mark Certification Under New MDR
MDSAP certification covers distribution in five countries, including the U.S., Japan, Canada, Australia, and Brazil.
Michael Barbella, Managing Editor
07.11.23
FDA Clears Hygh-Tec Catheter System for ICU Stool Drainage
Advanced Medical Balloon’s microscopically thin polyurethane balloon catheter systems address indications in intensive care.
Michael Barbella, Managing Editor
07.06.23
Canadian Regulators Approve FemCerv Endocervical Tissue Sampler
Femasys' product is the first endocervical tissue sampler designed to collect and contain a comprehensive sample to maximize quality and quantity.
Michael Barbella, Managing Editor
07.03.23
Trending
Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
Medtronic Obtains EU Nod For Simplera CGM
A New Approach To Post-Market Surveillance
Danaher Names New Environmental And Applied Solutions Company Veralto
Hologic, Bayer Team Up For Contrast-Enhanced Mammography
Breaking News
Beckman Coulter Helping Labs Comply With Annex 1 Regulation
FDA Clears MeMed BV Direct From Whole Blood
Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
Abbott Completes Acquisition of Bigfoot Biomedical
View Breaking News >
CURRENT ISSUE
September 2023
Superior Subtractive Solutions for Machining Medtech
Medical Device Industry Experts' Thought on Assembly & Automation
Power Trip: A Discussion of Custom Medical Electronics
The MDR Transition: An Opportunity for Design Change?
View More >