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Chronic Disease
Beta Bionics to Launch iLet Bionic Pancreas with Dexcom G7 CGM System
Starting Dec. 18, iLet users will be able to use a Dexcom G7 CGM System.Charles Sternberg, Associate Editor 12.07.23
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Nortech Systems Suzhou Facility Now Certified for Class II Medical Devices
The ISO 13485-certified facility employs a team of highly trained and experienced engineers and technicians.Michael Barbella, Managing Editor 12.07.23
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KORU Medical Systems Recruits Edward Wholihan to Its Board
New member has more than 25 years of experience as chief financial officer.Michael Barbella, Managing Editor 12.07.23
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BD Receives FDA 510(k) Clearances for Fingertip Blood Collection System
The BD MiniDraw Capillary Blood Collection System is less invasive than a traditional venous blood draw and more convenient.Charles Sternberg, Associate Editor 12.07.23
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Trace Medical, Outset Medical Team Up to Distribute the Tablo Hemodialysis System
New collaboration will help drive access for home medical equipment providers to first-of-its kind technology for home dialysis.Michael Barbella, Managing Editor 12.06.23
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Monarch eTNS System Approved by Singapore Regulators
The Monarch is the first-ever medical device to receive HSA approval as a treatment for pediatric ADHD.Michael Barbella, Managing Editor 12.06.23
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Cardiovascular
First Patient Treated in Study of PercAssist's PSCA System
The PercAssist System is a medical device that provides an extravascular solution for chronic heart failure patients who need hemodynamic support.Michael Barbella, Managing Editor 12.04.23
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Machining & Laser Processing
Machining 101: A Review of Machining Components with a Five-Axis System
This article offers a brief overview of the more pressing considerations to keep top of mind when embarking on a project requiring five-axis machining.Online Exclusives Yang Zhibin, Marketing Engineer, Able Medical (Dongguan) Co. Ltd. 12.01.23
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Diagnostics
Revvity Launches EONIS Q System
Simplifies and streamlines molecular testing for SMA and SCID.Charles Sternberg, Associate Editor 11.29.23
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Diagnostics
RSNA23: Philips Highlights Next-Gen Ultrasound Systems
Improves workflow and efficiency with EPIQ Elite and Affinity.Charles Sternberg, Associate Editor 11.29.23
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Diagnostics
RSNA23: Siemens Healthineers Introduces Acuson Maple Ultrasound System
New system is ideal for emerging markets, small hospitals, outpatient centers, private practices, and urgent care centers.Charles Sternberg, Associate Editor 11.28.23
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Diagnostics
RSNA23: Philips Showcases Mobile MRI System with Helium-Free Operations
BlueSeal MR Mobile’s magnet technology advances patient outcomes and access to care with high quality diagnostic imaging and enhanced workflows.Charles Sternberg, Associate Editor 11.27.23
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Surgical
FDA OKs Baird Medical's Microwave Ablation System
The minimally invasive, thermal energy-based procedure treats thyroid nodules, breast tumors, and other diseases.Sam Brusco, Associate Editor 11.22.23
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Chronic Disease
ViCentra Launches Hybrid Closed Loop System for Automated Insulin Delivery
Delivers insulin by using the DBLG1 algorithm, which receives input from the Dexcom G6 Continuous Glucose Monitoring (CGM) sensor.Charles Sternberg, Associate Editor 11.21.23
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Software & IT
LivaNova Discloses Cybersecurity Incident, Reports Disrupted IT Systems
The company admitted it couldn’t determine, at this time, the extent of the cybersecurity event’s impact.Sam Brusco, Associate Editor 11.21.23
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Vizient Awards Contract to Aspect Imaging for Embrace POC Neonatal MRI System
Embrace is the world’s first FDA-cleared and CE-approved MRI system designed specifically for the imaging needs of premature and newborn infants.Michael Barbella, Managing Editor 11.17.23
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Cardiovascular
FDA Clears Expanded Features for HyperVue Imaging System
The system now includes an expanded toolkit to optimize coronary stent placement in the cardiac catheterization lab.Michael Barbella, Managing Editor 11.16.23
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Diagnostics
First Home Chlamydia and Gonorrhea Testing System Nets De Novo Nod
The de novo marks the first FDA-authorized test with home sample collection for a sexually transmitted disease other than HIV.Sam Brusco, Associate Editor 11.16.23
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Cardiovascular
Recor Medical Completes First Commercial Cases with Renal Denervation System
The Paradise uRDN system lowers blood pressure by denervating overactive sympathetic nerves around the renal arteries.Sam Brusco, Associate Editor 11.13.23
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Endologix Gains New Technology Add-on Payment for DETOUR System
Hospitals using the PAD treatment are now receiving additional device reimbursement from CMS.Michael Barbella, Managing Editor 11.03.23
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Collaboration Takes Center Stage: PPMs, ASCs, and Health Systems Explore New Ground
Physicians, health systems, and other stakeholders are collaborating to meet the healthcare market’s demands.Joe Parise and Dana Dombey, McDermott Will & Emery LLP 11.01.23
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Cardiovascular
Getinge iCast Covered Stent System Becomes Commercially Available in U.S.
Is approved for the treatment of iliac arterial occlusive disease.Charles Sternberg, Associate Editor 10.30.23
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Insulet Releases Omnipod 5 Automated Insulin Delivery System in Germany
Product is now reimbursable, having received its medical aid numbers from the German National Association of Statutory Health Insurance Funds.Michael Barbella, Managing Editor 10.30.23
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FDA Fast Track Designation Granted to Nectero EAST System
The product is a single-use, endovascular system used to treat infrarenal abdominal aortic aneurysms.Michael Barbella, Managing Editor 10.27.23
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Diagnostics
Verasonics Launches Enhancements for the Vantage Research Ultrasound System
Company updates licensing permissions to provide researchers with improved flexibility for sharing programming scripts developed with the Vantage System.Michael Barbella, Managing Editor 10.20.23
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Microbot Medical Boosts Manufacturing, Commercialization Capabilities for Robotic System
Manufacturing agreement further strengthens the company's progression towards expected first-in-human clinical trials.Michael Barbella, Managing Editor 10.20.23
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Spectral AI Gains ISO Certification for DeepView System
The system received FDA Breakthrough Device Designation in 2018 for its burn indication.Michael Barbella, Managing Editor 10.19.23
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Digital Health | Patient Monitoring
Philips Reveals Open Ecosystem to Boost Health Monitoring, Care Coordination
Philips' patient monitoring system brings together disparate medical devices and systems on a single interface.Sam Brusco, Associate Editor 10.10.23
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Chronic Disease
HistoSonics' Edison Histotripsy System Gets De Novo OK
The Edison system is indicated for non-invasive destruction of liver tumors, including those that are unresectable.Sam Brusco, Associate Editor 10.09.23
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Positive Data Released for Route 92 Medical's FreeClimb 70 Reperfusion System
Study shows FreeClimb 70 Reperfusion System enables neurointerventionalists to address critical unmet needs in ischemic stroke treatment.Michael Barbella, Managing Editor 10.06.23
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CE Mark Awarded to Palliare's EVA15 Insufflator and Smoke Evacuation System
Company also signed its first U.S. GPO agreement with Northwell Health.Michael Barbella, Managing Editor 10.05.23
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Digital Health
Why Collaboration Matters for the Adoption of AI and Vision Systems in Medtech
Fostering collaboration between government bodies, research institutions, academia, and industry to focus on solutions and applications.Online Exclusives Rachel Shelly, Global Head Life Sciences & Food, and Talent, Transformation & Innovation, IDA Ireland 10.04.23
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ZOLL Expands Temperature Management Portfolio to Include IQool System
Agreement with BrainCool gives ZOLL both intravascular technology and surface options to help control patients' temperatures.Michael Barbella, Managing Editor 09.28.23
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Chronic Disease
3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
Klarity will offer VSP Bolus within its new line of high-quality patient-specific 3D printed products called Klarity Prints.Charles Sternberg, Associate Editor 09.27.23
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Surgical
Moon Surgical Completes First U.S. Cases with Maestro System
The Maestro system received CE mark approval last week.Sam Brusco, Associate Editor 09.26.23
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Surgical
Moon Surgical Earns EU Nod for Maestro Surgical Robotics System
The updated Maestro system has scalability and refined aesthetics.Sam Brusco, Associate Editor 09.20.23
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Neurological
INBRAIN Gets Breakthrough Nod for Intelligent Network Modulation System
The INBRAIN system uses a graphene-neural platform as an adjunctive therapy to treat Parkinson's disease.Sam Brusco, Associate Editor 09.19.23
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Chronic Disease
FDA OKs B. Braun's AQUAbase nX Reverse Osmosis System
AQUAbase nX provides high-quality water for dialysis patients without using chemicals.Sam Brusco, Associate Editor 09.18.23
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Diagnostics
EchoNous Increases Access to Kosmos System Across Multiple Operating Systems
The Kosmos system is now available on EchoNous’ own proprietary tablet as well as Android and iOS compatible tablets.Charles Sternberg, Associate Editor 09.18.23
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FDA Approves Urotronic's BPH Catheter System
The company won FDA approval for Optilume after running a clinical trial that compared the device to a sham treatment in 148 patients.Michael Barbella, Managing Editor 09.18.23
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Kurin Releases Advanced Blood Culture Collection System
The Kurin Jet passively sidelines the initial 0.15ml of blood, which may contain contaminants from the patient’s own skin.Michael Barbella, Managing Editor 09.14.23
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Surgical
FDA Clears Venus Versa Pro System
Venus Versa Pro is a multi-application platform for a variety of aesthetic and cosmetic procedures.Sam Brusco, Associate Editor 09.14.23
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Cardiovascular | Surgical
LimFlow System Earns FDA Nod for Chronic, Limb-Threatening Ischemia
The company believes treatment with its LimFlow TADV system could give CLTI patients a chance to save their limbs.Sam Brusco, Associate Editor 09.12.23
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Cardiovascular | Diagnostics
CorVista System OK'ed to Spot Presence of Cardiac Disease
The CorVista system with CAD Add-On was FDA-cleared as a diagnostic aid for significant coronary artery disease.Sam Brusco, Associate Editor 09.12.23
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3D/Additive Manufacturing
3D Systems & Clarkson College Partner to Establish 3D Printing and Training Center of Excellence
Will enable the creation of pathways that make 3D printing and visualization accessible to health care facilities across the region.Charles Sternberg, Associate Editor 09.06.23
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Tivic Health Systems, Cardinal Health Sign Distribution Agreement
Pact adds Tivic's bioelectronic sinus device to Cardinal Health's at-home portfolio.Michael Barbella, Managing Editor 09.05.23
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Andrew LaFrence Named CFO at KORU Medical Systems
New hire has nearly four decades of finance and accounting experience.Michael Barbella, Managing Editor 09.01.23
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Omnipod 5 Automated Insulin Delivery System Released in the U.K.
Omnipod 5 is the first CE marked tubeless hybrid closed loop system that integrates with the Dexcom G6 CGM System.Michael Barbella, Managing Editor 08.29.23
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FDA OKs Paragonix's BAROguard Donor Lung Preservation System
BAROguard is designed for automated active lung pressure and temperature management during critical donor lung transportation.Sam Brusco, Associate Editor 08.25.23
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Cardiovascular
Reflow Medical Shares Positive Data on Bare Temporary Spur Stent System
Results indicate a more than 50% reduction in vessel recoil.Michael Barbella, Managing Editor 08.22.23
