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Evaluations for the EU: The Impact on Testing & Lab Services
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Breaking News
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Supply Chain
Device Sectors
TFS HealthScience Acquires Appletree CI Group
Deal expands TFS's ophthalmology and medical device expertise.
Michael Barbella, Managing Editor
03.23.23
Relay Robotics Adds Three Executives to its Product Team
The additions aim to boost software engineering, product management, and industrial design.
Michael Barbella, Managing Editor
03.22.23
FDA Clears Atalante Hands-Free Self-Balancing Device
The self-stabilizing mobility device is designed for stroke patients’ rehabilitation.
Michael Barbella, Managing Editor
03.22.23
Kerecis Debuts New Fish-Skin Burn Products
The GraftGuide additions address the challenges of burn healing, and uneven burn surfaces.
Michael Barbella, Managing Editor
03.22.23
Molding
Accumold Compliments its Tech Capability With Micro AM
Micro molding provider purchases second Fabrica 2.0 machine.
Michael Barbella, Managing Editor
03.22.23
Cardiovascular
Abbott's CardioMEMS HF System Helps Manage Heart Failure
New clinical data shows remote pressure monitoring can improve heart failure patient survival by 25%.
Charles Sternberg, Associate Editor
03.22.23
Neurent Medical's Neuromark System Shows Promise for Chronic Rhinitis Patients in CLARITY Study
Patients who received the Neuromark therapy demonstrated significant improvement in rhinorrhea and nasal congestion symptoms at 3 months.
Charles Sternberg, Associate Editor
03.22.23
Surgical
SurgVision's EXPLORER AIR II Gets FDA OK
EXPLORER AIR II cleared for use with Pafolacianine during intraoperative fluorescence imaging.
Sam Brusco, Associate Editor
03.21.23
Cardiovascular
|
Neurological
Brainomix's Flagship Stroke AI Imaging Software OK'ed
The tool assesses non-contrast CT scans to automatically generate an ASPECTS score.
Sam Brusco, Associate Editor
03.21.23
Diagnostics
Cue Health Nabs EUA for Molecular Mpox Test
Nucleic acid amplification test can detect monkeypox virus and deliver results in 25 minutes.
Sam Brusco, Associate Editor
03.21.23
Cardiovascular
FDA Clears Viz.ai's AI Algorithm for Abdominal Aortic Aneurysm
Viz AAA is the first FDA-cleared, AI-powered solution to detect and triage suspected AAA.
Sam Brusco, Associate Editor
03.21.23
Patient Monitoring
Etiometry's IVCO2 Index Receives EU, Health Canada Authorization
The IVCO2 Index helps visualize inadequate carbon dioxide ventilation with other contextual data.
Sam Brusco, Associate Editor
03.21.23
Materials
|
Surgical
Advamedica's Ax-Surgi Surgical Hemostat Gains FDA Nod
First and only chitosan-based hemostat cleared to control severe surgical bleeding.
Sam Brusco, Associate Editor
03.21.23
Inspire Medical Systems Gains FDA Approval for Pediatric Patients with Down Syndrome
The approval now covers obstructive sleep apnea patients at least 13 years old.
Sam Brusco, Associate Editor
03.21.23
Genetesis Adds Three New Members to its Executive Team
Company expecting FDA approval later this year for CardioFlux.
Michael Barbella, Managing Editor
03.21.23
Able Medical Releases to Market its Looped Sternotomy Sutures
The Valkyrie suture is a stainless-steel looped wire suture used to approximate sternums.
Michael Barbella, Managing Editor
03.21.23
Patient Monitoring
Tool Uses AI to Detect Early Warning of Patient Illness
CoMET continuously monitors data to detect subtle physiological changes.
Michael Barbella, Managing Editor
03.21.23
Machine Solutions Acquires Vela Technologies
Advanced equipment provider enhancing medical device manufacturing offerings with 3D UV curing technology.
Michael Barbella, Managing Editor
03.21.23
J&J Exec Ashley McEvoy Named AdvaMed's New Chairman
McEvoy leads J&J’s $27 billion medtech business.
Sam Brusco, Associate Editor
03.21.23
Surgical
Asensus' Senhance Surgical Robot OK'ed for U.S. Pediatric Patients
Senhance is already approved for pediatric patients in the EU and Japan.
Sam Brusco, Associate Editor
03.21.23
Breaking News
Art Taylor Named to Endologix Board of Directors
Michael Bourque Named Chief Financial Officer at Inogen
FDA Grants Breakthrough Designation to AbSolutions' REBUILD Device
JenaValve Publishes ALIGN-AR Pivotal Trial Results
HHS Releases New Performance Goals to Enhance Healthcare Cybersecurity
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 >