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Partner Preference in Full-Service Medical Device Outsourcing
Spot Check: A Discussion of the In-Vitro Diagnostics Market
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CorVista System with Pulmonary Hypertension Add-On Cleared by FDA
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ICON CFO to Leave Job in Fourth Quarter
Olympus Launches 2 Bronchoscopes for EVIS X1 Endoscopy System
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Partner Preference in Full-Service Medical Device Outsourcing
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Industry Articles
Cardiovascular
CorVista System with Pulmonary Hypertension Add-On Cleared by FDA
The PH Add-On expands clinicians' point-of-care diagnostic capabilities to more efficiently identify CAD and PH cardiovascular conditions.
Michael Barbella, Managing Editor
05.14.24
Cardiovascular
Study Initiated to Evaluate Efficacy of Esophageal Cooling During RF Ablation Procedures
Attune Medical's ensoETM is a single-use thermal regulating device placed in the esophagus and connected to an external heat exchange unit.
Michael Barbella, Managing Editor
05.14.24
Cardiovascular
Stereotaxis Begins Deal to Acquire Access Point Technologies
Minnesota-based APT touts a portfolio of diagnostic catheters used in cardiac ablation procedures.
Sam Brusco, Associate Editor
05.14.24
Diagnostics
Siemens Healthineers Starts Construction on £250M Oxford Facility
The 56,000 m2 carbon-neutral site will manufacture new MRI cooling technology.
Rachel Klemovitch, Assistant Editor
05.13.24
Chronic Disease
Arecor, Medtronic Diabetes Collaborate on Thermostable Insulin
Medtronic funds Arestat, a high-concentration thermostable insulin, to use with a next-generation implantable pump.
Rachel Klemovitch, Assistant Editor
05.13.24
Cardiovascular
Data Show Benefits of Vektor Medical's vMap Arrhythmia Mapping Tech
Study results demonstrate a 22.6% reduction in ablation procedure duration.
Michael Barbella, Managing Editor
05.13.24
Cardiovascular
Paroxysmal Enrollment in Kardium's PULSAR IDE Study Completed
Trial aims to determine the safety/effectiveness of the firm's Globe System for atrial fibrillation treatment.
Michael Barbella, Managing Editor
05.13.24
Cardiovascular
Biotronik Enrolls First Patient in BIOMAG-II Trial of Freesolve Resorbable Scaffold
The international trial will evaluate the Freesolve resorbable magnesium scaffold against a contemporary drug-eluting stent.
Sam Brusco, Associate Editor
05.13.24
Digital Health
CLEW Medical Nabs FDA Nod for 2nd-Gen AI Models
The FDA clearance advances CLEW's predictive patient deterioration technology with more accuracy.
Sam Brusco, Associate Editor
05.13.24
Cardiovascular
Medtronic's Pulsed Field Ablation Earns Japanese Approval
A new software upgrade also became available for the PulseSelect PFA system, which features an automated delivery mode.
Sam Brusco, Associate Editor
05.10.24
Cardiovascular
|
Neurological
Route 92 Recalls Certain Neurovascular Catheters After 2 Injuries, 1 Death
The company said the affected Tenzing 7 catheters breaking at the proximal marker band were manufactured by an outside contract supplier.
Sam Brusco, Associate Editor
05.10.24
Diagnostics
FDA Clears QuidelOrtho's COVID-19 Test
QuickVue provides test results in 10 minutes.
Michael Barbella, Managing Editor
05.10.24
Cardiovascular
Pulse Biosciences Completes First U.S. Procedure with Pulsed Field Ablation Electrode Tech
The system is comprised of a percutaneous needle electrode used with the proprietary CellFX nsPFA console.
Sam Brusco, Associate Editor
05.10.24
Chronic Disease
|
Patient Monitoring
Senseonics, Rimidi Team Up for Remote Diabetes Monitoring
Eversense glucose data will be integrated into Rimidi’s clinical management platform.
Sam Brusco, Associate Editor
05.10.24
Surgical
FDA OKs Freyja HealthCare's Novel VereSee Device
VereSee is a first-of-its-kind, 2 mm abdominal-access device for laparoscopic surgery.
Sam Brusco, Associate Editor
05.09.24
Cardiovascular
Field Medical Starts First-in-Human Pulsed-Field Ablation Trial
Field Medical's founder and CEO was also the founder of PFA company Farapulse.
Sam Brusco, Associate Editor
05.09.24
Cardiovascular
Edwards Rolls Out Sapien 3 Ultra Resilia TAVR in Europe
Resilia tissue has anti-calcification properties and can be stored under dry packaging conditions.
Sam Brusco, Associate Editor
05.09.24
Packaging & Sterilization
What Happened to the Reprocessing of Single-Use Devices?—ThrowbackThursday
Reprocessing of single-use devices was all the rage in 2000 and causing quite the stir with patient safety at the forefront of the debate.
Online Exclusives
Sean Fenske, Editor-in-Chief
05.09.24
Chronic Disease
|
Digital Health
|
Software & IT
Tandem Diabetes t:connect Mobile App v2.7 for t:slim X2 Pump Recall Is Class I
A software issue can cause the mobile app to crash and be automatically relaunched by iOs.
Sam Brusco, Associate Editor
05.08.24
Cardiovascular
4C Medical Gets 2 FDA Breakthough Nods for AltaValve TMVR Device
The AltaValve transcatheter mitral valve replacement device differentiates from others with atrial-only fixation, preserving the native mitral valve.
Sam Brusco, Associate Editor
05.08.24
Breaking News
CorVista System with Pulmonary Hypertension Add-On Cleared by FDA
Study Initiated to Evaluate Efficacy of Esophageal Cooling During RF Ablation Procedures
Kryptos Secures Funding to Study its POC Molecular Diagnostics System
ICON CFO to Leave Job in Fourth Quarter
Olympus Launches 2 Bronchoscopes for EVIS X1 Endoscopy System
View Breaking News >
CURRENT ISSUE
May 2024
Partner Preference in Full-Service Medical Device Outsourcing
Spot Check: A Discussion of the In-Vitro Diagnostics Market
Innovative Iteration for Medical Device Design
View More >