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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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Device Sectors
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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
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
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
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
Diagnostics
|
Software & IT
Precision Diagnostics Save Lives, Optimize Workforce, and Boost Efficiency
Leveraging AI and machine learning tools can enhance a facility’s productivity and precision.
Pravin Vazirani, Assistant Vice President of Operations, Chetu
07.24.24
Surgical
The Changing Role of Suppliers in the Robotic-Assisted Surgery Market
Micro manufacturing of metal and plastic/elastomeric components offers incumbent suppliers a strong strategy.
Tony Freeman, President, A. S. Freeman Advisors LLC
07.24.24
Cardiovascular
|
Digital Health
New AI-Powered Tech Can Predict Cardiac Events a Decade in Advance
Study conclusions based on a comprehensive evaluation of Caristo Diagnotics' CaRi-Heart AI technology.
Michael Barbella, Managing Editor
07.23.24
Cardiovascular
|
Surgical
AtriCure Gets Approval for AtriClip Sale in China
Chinese approval was based on clinical data showing AtriClip’s safety and efficacy.
Sam Brusco, Associate Editor
07.23.24
Cardiovascular
Magenta Medical Gains $105M Funding for Elevate Percutaneous LVAD
The financing will help to advance the company’s U.S. clinical programs in multiple mechanical circulatory support indications.
Sam Brusco, Associate Editor
07.23.24
Cardiovascular
Volta Medical, GE HealthCare Team Up for AI-Powered Electrophysiology
The duo aims to combine their tech to support electrophysiologists during catheter ablation to treat AFib.
Sam Brusco, Associate Editor
07.23.24
Chronic Disease
|
Diagnostics
Guardant Health Releases Major Upgrade to Liquid Biopsy Test
The new test evaluates biomarkers in 739 total genes, 10 times more cancer biomarkers than the previous version of Guardant360.
Sam Brusco
07.23.24
Diagnostics
Proov Launches Proov Empower Perimenopause Testing System
Proov Empower is an at-home perimenopause test to guide hormone balance.
Rachel Klemovitch, Assistant Editor
07.23.24
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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