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Lessons from the Pandemic: Mitigating Product Liability Risk in Supply Chains
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Linus Health Acquires Together Senior Health
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KORU Medical Systems Announces Leadership Changes
Abbott Issues Voluntary Medical Device Correction for Small Number of Freestyle Libre 3 Sensors
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Medical Molders Are Specialized Sculptors
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Breaking News
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Supply Chain
Device Sectors
Neurological
Linus Health Acquires Together Senior Health
The deal expands Linus’ virtual therapeutic platforms to offer end-to-end workflow capabilities.
Rachel Klemovitch, Assistant Editor
07.26.24
Software & IT
GE HealthCare, AWS Team Up on Clinical Generative AI Apps
The collaboration will focus on developing multi-modal foundation models to analyze a huge array of unstructured medical data.
Sam Brusco, Associate Editor
07.26.24
Align Technology Introduces iTero Design Suite
This software offers intuitive design capabilities for in-practice 3D printing of models, bite splints, and restorations.
Rachel Klemovitch, Assistant Editor
07.25.24
KORU Medical Systems Announces Leadership Changes
Christopher Pazdan was appointed Chief Operating Officer, effective July 18, 2024.
07.25.24
Chronic Disease
Abbott Issues Voluntary Medical Device Correction for Small Number of Freestyle Libre 3 Sensors
This correction impacts a small subset of FreeStyle Libre 3 sensors from among those within three lots in the U.S. only.
Rachel Klemovitch, Assistant Editor
07.25.24
Diagnostics
FDA Grants bioMérieux Special 510(k) Clearance and CLIA-waiver for New BIOFIRE SPOTFIRE Panel
This Respiratory/Sore Throat (R/ST) Panel Mini is the fourth panel in the BIOFIRE SPOTFIRE range.
Rachel Klemovitch, Assistant Editor
07.25.24
Diagnostics
bioMérieux Gains US FDA 510(k) Clearance for VITEK REVEAL AST System
The VITEK REVEAL AST System results come directly from positive blood cultures.
Rachel Klemovitch, Assistant Editor
07.25.24
Diagnostics
Microstructure Imaging Gains FDA Clearance for MICSI-RMT
MICSI-RMT is a software suite, designed to enhance MRI image quality.
Rachel Klemovitch, Assistant Editor
07.25.24
Cardiovascular
First-in-Human Implantation of BiVACOR's Total Artificial Heart
The Texas Institute conducted the implant procedure on a patient with end-stage heart failure.
Rachel Klemovitch, Assistant Editor
07.25.24
Neurological
Arsenal Medical Releases NeoCast Clinical Trial Results
Data show NeoCast met primary endpoints and enabled significant distal penetration of hypervascular brain tumors.
Rachel Klemovitch, Assistant Editor
07.25.24
Hologic Finalizes Endomagnetics Acquisition
Hologic purchased the UK-based breast cancer technologies company for $310 million.
Rachel Klemovitch, Assistant Editor
07.25.24
Heather Simonsen Joins Access Vascular's Board of Directors
New board member is president and CEO of Boomerang Medical.
Michael Barbella, Managing Editor
07.24.24
Endoron Medical Raises $10 Million in Series A Funding
The money will help Endoron pursue clinical validation of its Artoseal product.
Michael Barbella, Managing Editor
07.24.24
Diagnostics
|
Digital Health
Study: AI-Enhanced MRI Selection Method Enhances Breast Cancer Detection
A newly developed AI technology can accurately assess mammogram images and identify women at high risk for missed cancer.
Michael Barbella, Managing Editor
07.24.24
Cardiovascular
Breakthrough Device Designation Awarded to CellFX Cardiac Surgery System
Pulse Biosciences' CellFX nsPFA tech delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue.
Michael Barbella, Managing Editor
07.24.24
Cardiovascular
Edwards to Buy JenaValve & Endotronix for $1.2B
The acquisitions expand Edwards' ability to address the unmet needs of aortic regurgitation and heart failure patients.
Sam Brusco, Associate Editor
07.24.24
Surgical
Biogennix Launches New Agilon Surgical Matrix
This new wound care solution helps to create a successful wound-healing environment.
Rachel Klemovitch, Assistant Editor
07.24.24
FDA’s CDRH Director Jeff Shuren to Retire
Dr. Michelle Tarver will assume the role of acting director, effective July 28.
Rachel Klemovitch, Assistant Editor
07.24.24
Cardiovascular
Peerbridge Health Begins Enrollment for EF-ACT Pivotal Trial
The trial will measure ejection fraction severity from an AI-enabled remote ECG wearable.
Rachel Klemovitch, Assistant Editor
07.24.24
Three Companies Form the MedTech Laser Group
The Group consists of ARC Laser, neoLaser, and Afinum 9.
Rachel Klemovitch, Assistant Editor
07.24.24
Breaking News
Linus Health Acquires Together Senior Health
GE HealthCare, AWS Team Up on Clinical Generative AI Apps
Align Technology Introduces iTero Design Suite
KORU Medical Systems Announces Leadership Changes
Abbott Issues Voluntary Medical Device Correction for Small Number of Freestyle Libre 3 Sensors
View Breaking News >
CURRENT ISSUE
July/August 2024
Designing Medical Devices with Human Factors Engineering
Mitigating Product Liability Risk in Supply Chains
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