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Evaluations for the EU: The Impact on Testing & Lab Services
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Evaluations for the EU: The Impact on Testing & Lab Services
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Software & IT
AI Metrics' Liver Imaging Software Earns FDA Nod
Early-stage startup approved for low-cost, low-risk, non-invasive procedures for chronic liver disease patients.
University of Alabama at Birmingham
12.09.20
Digital Health
FDA OKs AireHealth's VitalMed Connected Nebulizer
Bluetooth-enabled, portable nebulizer will help track symptoms and support medication adherence.
Business Wire
12.09.20
FDA Authorizes CorVent's RESPOND-19 Ventilator for Multiple Patient Use
Provides reliable and affordable deployment to treat more patients during surges in clinical demand.
PR Newswire
12.09.20
Modulim Promotes COO to President, CEO
Charles Huiner brings over 25 years of medical device industry executive experience.
Business Wire
12.09.20
Chronic Disease
Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine
The Carpediem system is designed to treat patients requiring renal replacement therapy weighing between 2.5 and 10 kilograms (5.5 to 22 pounds).
PR Newswire
12.08.20
Materials
DURECT to Sell LACTEL Absorbable Polymer to Evonik for $15M
Expands Evonik's position as a global CDMO for drug delivery solutions.
PR Newswire
12.08.20
Survey Finds On-Site Inspections Plummeted by 93 Percent
Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.
Greenlight Guru
12.08.20
Diagnostics
Combo COVID-19, Flu Home Test Gains EUA
FDA authorizes first COVID-19 and flu combination test for use with home-collected samples.
U.S. Food and Drug Administration
12.08.20
MedAcuity Partners With Loft to Support the Full MedTech Product Development Lifecycle
Companies will focus on designing hardware and software that acts in harmony in a single diagnostic or wearable medical device or system.
MedAcuity
12.08.20
SuperResolution Added to World’s Smallest Camera Module for Endoscopic Medical Imaging
Solution combines OmniVision’s Wafer-Level CameraCubeChip Technology with Almalence’s SuperResolution algorithm for images of tiny anatomy parts.
OmniVision Technologies Inc.
12.08.20
Study: Linx Reflux Management System Provides Long-Term Control of GERD
LINX eliminated daily dependance on acid-reflux medications in 79 percent of GERD patients.
Johnson & Johnson Medical Devices Companies
12.08.20
APAC Breathing Filters, Bags Market to Grow 4 Percent in Next Decade
China will account for more than one-third of the market by 2030.
GlobalData
12.08.20
Polygon Composites Appoints CEO
Randy Rice is a seasoned manufacturing executive with over 30 years of experience.
Polygon Composites
12.08.20
Chronic Disease
New Research Sheds Light on Potential Glaucoma Treatment
Hydrogels could provide an alternative to drugs or surgery.
Georgia Institute of Technology
12.07.20
Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor
The wearable sensor is now recognized as a medical device in Europe, capable of providing continuous, medical-grade measurements of a person’s activity.
Shimmer Research
12.07.20
Diagnostics
CRISPR-Based COVID-19 Test Uses Smartphone Camera
The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.
PR Newswire
12.07.20
Manufacturer Develops New Ventilator Sensor
The sensor took only 14 weeks from concept, through validation, to manufacture and delivery.
Hummingbird Sensing Technology
12.07.20
Diagnostics
Handheld DNA ‘Tricorder’ Developed
Device couples with an iPhone app to enable a mobile genetics laboratory.
PR Newswire
12.07.20
LivaNova Announces Board Changes
Update includes the appointment of a new member as well as board leadership changes.
Business Wire
12.07.20
FDA Clears AireHealth’s Connected Nebulizer
The company’s Bluetooth-enabled, portable nebulizer will help patients track symptoms and support medication adherence.
Business Wire
12.07.20
Breaking News
Getinge Donates Extensive Medical Equipment to Ukraine
Olympus Names Julien Sauvagnargues CEO of the Americas
Mark Pugh Assumes CEO Role at Theragenics
Art Taylor Named to Endologix Board of Directors
Michael Bourque Named Chief Financial Officer at Inogen
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 >