Knowledge Center
Industry Articles
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Surgical
Ethicon Unveils ECHELON LINEAR Cutter in U.S.
Product is capable of delivering 47% fewer leaks at the staple line to help reduce surgical risks.Michael Barbella, Managing Editor 05.28.24
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Cardiovascular
Nordson to Buy Atrion Corporation for $800 Million
Atrion, made up of Halkey Roberts, Atrion Medical, and Quest Medical, specializes in medical infusion fluid delivery and niche cardiovascular solutions.Sam Brusco, Associate Editor 05.28.24
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Diagnostics
QT Imaging's Tech Similarly Effective as Digital Breast Tomosynthesis
The company's solution has a high specificity in determining benign cysts and thus decreasing benign recall rates, according to study data.Michael Barbella, Managing Editor 05.28.24
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Digital Health
SimBioSys, Magic Leap Team Up on Surgical Oncology Treatment
The pair is integrating SimBioSys's AI-powered TumorSight Viz product with Magic Leap's augmented reality technology.Michael Barbella, Managing Editor 05.28.24
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Chronic Disease | Digital Health
CamDiab Wins FDA Nod for Hybrid Closed-Loop Insulin Delivery App
The CamAPS FX app lets a compatible insulin pump and continuous glucose monitor “speak” to each other and create an “artificial pancreas.”Sam Brusco, Associate Editor 05.28.24
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Cardiovascular | Patient Monitoring
FDA OKs Terumo's CDI OneView Monitoring System
The next-gen CDI Systems platform offers visibility of key parameters during pulmonary bypass surgery.Sam Brusco, Associate Editor 05.28.24
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Diagnostics
Babson Diagnostics Develops Hand-Warming Device for Capillary Blood Samples
Company collaborated with the University of Texas at Austin on a prototype design.Michael Barbella, Managing Editor 05.24.24
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Cardiovascular
Foldax Marks TRIA Surgical Valve Milestone
The product's proprietary polymer has been shown to resist calcification.Michael Barbella, Managing Editor 05.24.24
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Cardiovascular | Surgical
Stereotaxis Earns CE Mark Recertification Under EU's MDR
The recertification covers all the company’s devices available in Europe.Sam Brusco, Associate Editor 05.24.24
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Cardiovascular | Neurological
FDA OKs Heuron ICH AI-Powered Stroke Triage and Notification Tool
The AI solution automatically screens and signals potential intracranial hemorrhage cases using only non-contrast CT images.Sam Brusco, Associate Editor 05.24.24
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Neurological
CorTec Wins FDA IDE Nod for Closed-Loop Brain Interchange Implant System
The IDE study will evaluate a novel stroke rehab treatment that uses cortical stimulation to enhance the brain’s plasticity.Sam Brusco, Associate Editor 05.24.24
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Cardiovascular
Vivasure Medical's PerQseal Elite Used in First Large Hole Venous Treatment
Investigational technology is designed for patients undergoing emerging large bore percutaneous catheter-based venous interventional procedures.Michael Barbella, Managing Editor 05.23.24
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Cardiovascular
New Study Data Bolsters Clinical Support for CVRx's Barostim
Patients in a trial with Barostim + GDMT had a 74% reduced risk of needing/receiving advanced heart failure interventions.Michael Barbella, Managing Editor 05.23.24
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Cardiovascular
FDA Admits Simpson Interventions Into its TAP Pilot Program
The agency designated the company's Acolyte Catheter System as a Breakthrough Device earlier this year.Michael Barbella, Managing Editor 05.23.24
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Contract Manufacturing
The Critical Role of Outsourcing in Medical Device Cleaning
What to consider when looking for a partner to outsource cleaning operations such as your cleaning needs, regulatory standards, and planned phasing.Online Exclusives Elizabeth Norwood, Senior Chemist at MicroCare, LLC 05.23.24
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Cardiovascular
Study: Paragonix Heart Preservation Tech Can Help Improve Post-Transplant Survival
Data show a 5% increase in two-year survival after a heart transplant.Michael Barbella, Managing Editor 05.22.24
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Chronic Disease | Digital Health
Click Therapeutics Acquires Defunct Better Therapeutics' Assets
The move aims to accelerate development initiatives in obesity and cardiometabolic disease.Sam Brusco, Associate Editor 05.22.24
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Software & IT
GE HealthCare Tops List of AI-Enabled Medical Device Authorizations for 3rd Year Running
FDA’s list of AI-enabled device authorizations includes over 850 devices; 72 are from GE HealthCare.Sam Brusco, Associate Editor 05.22.24
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Cardiovascular
SmartHeart ECG Tech Decreases Hospital Readmissions in Study
Trial data reveal a 41% decrease in emergency department visits and notable reductions in cardiac-related symptoms.Michael Barbella, Managing Editor 05.22.24
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Cardiovascular
AngioDynamics Gets EU Nod for AlphaVac 18(85) System
The system non-surgically removes thrombi or emboli from pulmonary arteries, and treats pulmonary embolism.Sam Brusco, Associate Editor 05.22.24
