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Lessons from the Pandemic: Mitigating Product Liability Risk in Supply Chains
Designing Medical Devices for the Human Touch
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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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Lessons from the Pandemic: Mitigating Product Liability Risk in Supply Chains
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Medical Molders Are Specialized Sculptors
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Chronic Disease
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Cardiovascular
Chronic Disease
Diagnostics
Digital Health
Neurological
Patient Monitoring
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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
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
Chronic Disease
Varian Gets FDA OK for Ethos Radiotherapy Upgrades
The new upgrades remove complexity to enable wider access to highly personalized cancer care.
Sam Brusco, Associate Editor
07.22.24
Chronic Disease
|
Diagnostics
Brainomix and Boehringer Ingelheim Enter Strategic Partnership in Fibrosing Lung Disease
Brainomix’s e-Lung imaging software will be used to improve the identification and access to treatment for people with progressive pulmonary fibrosis in the US.
Rachel Klemovitch, Assistant Editor
07.22.24
Chronic Disease
Photocure Enters Agreement with Richard Wolf for Flexible Blue Light Cystoscope
The agreement includes the development and commercialization of a reusable flexible blue light cystoscope.
Rachel Klemovitch, Assistant Editor
07.22.24
Chronic Disease
|
Surgical
Innoblative Achieves First-in-Human for Novel Electrosurgical Device for Breast Cancer
The SIRA device successfully treated a 64-year-old patient with stage II luminal A breast cancer.
Sam Brusco, Associate Editor
07.16.24
Chronic Disease
Vivani Plans to Begin GLP-1 Implant Study for Weight Management in Q4
The Australian LIBERATE-1 study will evaluate Vivani’s exenatide NanoPortal implant in obese or overweight patients.
Sam Brusco, Associate Editor
07.11.24
Chronic Disease
|
Patient Monitoring
Roche Gets EU Nod for AI-Enabled CGM System
Accu-Chek SmartGuide sends glucose values every five minutes; Predict app helps detect patterns and predict future levels.
Sam Brusco, Associate Editor
07.10.24
Chronic Disease
|
Diagnostics
Researchers Develop Noninvasive Urine Test for Early Detection of Cervical Cancer Virus Proteins
The test is developed at Waseda University in Japan and detects oncoproteins in urine.
Rachel Klemovitch, Assistant Editor
07.09.24
Chronic Disease
Kerecis Releases Shield Spiral Customizable Fish-Skin Wound Graft
The fish-skin graft and silicone combination has perforated fenestration marks cut in a spiral pattern to customize the graft size.
Sam Brusco, Associate Editor
07.08.24
Chronic Disease
Carthera Receives Positive Opinion from French High Authority
The company hopes to get temporary funding from Forfait Innovation for the first registration trial of SonoCloud in France.
Rachel Klemovitch, Assistant Editor
07.02.24
Chronic Disease
|
Surgical
Merit Medical Buys EsophyX Z+ Endoscopic GERD Device for $105M
The device, made by EndoGastric Solutions, treats GERD using transoral incisionless fundoplication (TIF 2.0).
Sam Brusco, Associate Editor
07.01.24
Chronic Disease
CeQur Gets FDA OK for Longer Wear of Mealtime Insulin Delivery Patch
The Simplicity patch is now cleared for one-day longer wear time, replacing up to 12 mealtime insulin injections.
Sam Brusco, Associate Editor
07.01.24
Chronic Disease
VenoStent Raises $20M for SelfWrap Perivascular Wrap
The wrap goes around arteriovenous access sites during AV fistula creation surgery for hemodialysis.
Sam Brusco, Associate Editor
06.28.24
Chronic Disease
Insulet Data Backs Omnipod 5 for Type 2 Diabetes, Seeks Expanded FDA OK
The study assessed the impact of AID in a diverse range of participants with type 2 diabetes who need insulin.
Sam Brusco, Associate Editor
06.24.24
Chronic Disease
Tandem Diabetes Data Shows Improved Quality of Life with Mobi Insulin Pump
The survey found 86% of participants were satisfied or very satisfied with Mobi, regardless of prior therapy.
Sam Brusco, Associate Editor
06.24.24
Chronic Disease
Insulet Launches Omnipod 5 with Expanded Sensor Integrations in the UK and the Netherlands
The Omnipod 5 for type 1 diabetes is compatible with Dexcom G6 and Abbott FreeStyle Libre2 Plus CGM sensors.
Rachel Klemovitch, Assistant Editor
06.21.24
Chronic Disease
Insulet Fully Rolls Out Omnipod 5 with Dexcom G7 in U.S., Launches iPhone App
The company also released Omnipod 5 in France with Dexcom 6 CGM compatibility.
Sam Brusco, Associate Editor
06.20.24
Chronic Disease
Abbott Gains FDA Clearances for Two Over-the-Counter CGM Systems
Lingo and Libre Rio are based on FreeStyle Libre sensing technology.
Rachel Klemovitch, Assistant Editor
06.10.24
Chronic Disease
|
Patient Monitoring
Glucotrack Has More Data for Implantable Blood Glucose Monitor
The company expects to begin human trials of its continuous blood glucose monitor later this year.
Sam Brusco, Associate Editor
06.07.24
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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