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Cardiovascular
Penumbra's Next-Gen Computer-Assisted Vacuum Thrombectomy Wins FDA Nod
Lightning Flash 2.0 has advanced algorithms to increase speed and sensitivity to thrombus and blood flow.
Sam Brusco, Associate Editor
04.24.24
Cardiovascular
|
Diagnostics
Exo Rolls Out AI-Powered Cardiac, Lung Tools for Handheld Ultrasound
The company now has FDA 510(k) clearances on five applications: cardiac, lung, bladder, hip, and thyroid.
Sam Brusco, Associate Editor
04.24.24
ISO 13485 Certification Awarded to Scherdel Medtec North America
Company began its certification process two years ago.
Michael Barbella, Managing Editor
04.23.24
FDA Clears AIOMEGA’s Sleep Apnea Treatment Solution
AIO Breathe acts by increasing the patient’s airway during sleep, improving ability to exchange air.
Michael Barbella, Managing Editor
04.23.24
Empatica Initiates AI Seizure Forecasting Study With Debut of Epilepsy Watch
EpiMonitor uses the EmbracePlus wearable and a mobile app to detect and alert for seizures.
Michael Barbella, Managing Editor
04.23.24
Cardiovascular
Enrollment Complete in Study of FIRE1's Remote Heart Failure Monitoring System
The FIRE1 system is a small, minimally invasive implantable sensor designed to accurately identify fluid volume build-up earlier.
Michael Barbella, Managing Editor
04.23.24
Cardiovascular
Medtronic Releases Avalus Ultra Surgical Aortic Tissue Valve
The Avalus Ultra valve is, at present, only commercially available in the U.S.
Sam Brusco, Associate Editor
04.22.24
Contract Manufacturing
Partner Preference in Full-Service Medical Device Outsourcing
Recent events have created a reevaluation of medical device manufacturing suppliers and a quest for true partners to achieve mutual success.
Sean Fenske, Editor-in-Chief
04.22.24
Culture and Talent Experience: Keys to Organizational Performance
For many companies, this is unfolding to be a year of empowering their people.
Tania de Decker, Managing Director—Global Strategic Accounts, Randstad Enterprise Group
04.22.24
Cardiovascular
|
Neurological
Expanse ICE Aspiration Catheter System Wins FDA Nod
Expanse ICE harnesses the aspiration power found in a large bore catheter, in the slender profile of a much smaller device.
Sam Brusco, Associate Editor
04.22.24
First Clinical Trial Patient Treated With Pulmonx's AeriSeal System
The AeriSeal System shows promise in limiting collateral ventilation.
Michael Barbella, Managing Editor
04.22.24
Cardiovascular
|
Digital Health
Partho Sengupta Joins HeartSciences' Scientific Advisory Board
New member is the Henry Rutgers Professor and the chief of Division of Cardiology at Rutgers Robert Wood Johnson Medical School.
Michael Barbella, Managing Editor
04.22.24
Cardiovascular
|
Neurological
J&J's CERENOVUS Rolls Out Next-Gen Ischemic Stroke Catheter in Europe
The Cereglide 71 aspiration catheter is used to revascularize patients suffering from ischemic stroke.
Sam Brusco, Associate Editor
04.22.24
Clinical Consultants to Provide Regulatory, Development Help to Futura Surgicare
Futura produces surgical sutures, skin staplers, hernia meshes, surgical tapes, hemostats, and bone wax.
Michael Barbella, Managing Editor
04.19.24
Cardiovascular
Smart AED Maker Avive Pockets $56.5M in Growth Funding
The company said the new funds will be used to boost its U.S. commercial developments and expand its team with top talent.
Sam Brusco, Associate Editor
04.19.24
Diagnostics
GE HealthCare Rolls Out New AI-Powered Ultrasound for Women's Health
The Voluson Signature 20 and 18 ultrasound systems integrate AI, advanced tools, and ergonomic design, to meet challenges in women's health.
Sam Brusco, Associate Editor
04.18.24
Cardiovascular
Reprieve Cardiovascular Emerges From Stealth Mode With $42M Financing
Money will enable the company to advance current and future clinical programs.
Michael Barbella, Managing Editor
04.17.24
Wearable Neuromodulation System for Urinary Incontinence Makes its Debut
Avation Medical’s Vivally System eliminates the need for surgery, drugs, and needles.
Michael Barbella, Managing Editor
04.17.24
Cardiovascular
FineHeart Widens FlowMaker's International IP Protection
The new patents increase the company's solid international portfolio to 147 within 25 patent families.
Michael Barbella, Managing Editor
04.17.24
Cardiovascular
Sparrow BioAcoustics Debuts Stethophone
Stethophone harnesses a smartphone's built-in microphone to capture the heart's nuanced sounds.
Michael Barbella, Managing Editor
04.16.24
Cardiovascular
Abbott's Latest HeartMate LVAD Recall Linked to 14 Deaths
The recall was made because of an issue called extrinsic outflow graft obstruction.
Sam Brusco, Associate Editor
04.16.24
ProCell Surgical's Sponge Blood Recovery Unit Approved in Europe
Product's patented design replaces the need for manually hand-wringing surgical sponges.
Michael Barbella, Managing Editor
04.15.24
Cardiovascular
Simpson Interventions Nabs Breakthrough Nod for Acolyte Image-Guided Crossing & Re-entry Catheter
Acolyte facilitates guidewire and catheter placement and positioning in coronary vasculature to treat coronary chronic total occlusions.
Sam Brusco, Associate Editor
04.12.24
Diagnostics
|
Patient Monitoring
Ultrasound Wearable Can Detect Internal Organ Stiffness
Sticky, wearable sensor developed by MIT researchers could help identify early signs of acute liver failure.
Michael Barbella, Managing Editor
04.12.24
Digital Health
FDA Clears AI Algorithm for Intracerebral Hemorrhage Quantification
New algorithm enables precise and reliable quantification of intracerebral hemorrhage so clinicians can make accurate and timely treatment decisions.
Michael Barbella, Managing Editor
04.11.24
Cardiovascular
Procyrion Closes $57.7 Million in Series E Financing
Money will be used to fund a clinical trial evaluating the company's catheter-deployed pump, Aortix.
Michael Barbella, Managing Editor
04.11.24
Cardiovascular
Getinge Gains EU MDR Approval for Advanta V12 Covered Stent System
Advanta V12 is designed for patients with aortoiliac occlusive disease, including lesions at the aortic bifurcation.
Rachel Klemovitch, Assistant Editor
04.11.24
FDA Clears Zynex's Next-Generation NMES Device
The M-Wave replaces its predecessor, the E-Wave.
Michael Barbella, Managing Editor
04.10.24
Cardiovascular
J&J's Biosense Webster Reveals Positive Dual-Energy Ablation Results
Trial results from the SmartfIRE trial of the Dual Energy Thermocool Smarttouch SF catheter for AFib.
Sam Brusco, Associate Editor
04.09.24
Cardiovascular
Medtronic's Evolut TAVR Outperforms Edwards' Sapien in Head-to-Head Trial
Medtronic's SMART trial is also the largest TAVR trial to date to enroll primarily women (87%).
Sam Brusco, Associate Editor
04.08.24
Toku Wins CE, UKCA Marks for AI-Enabled Cardiovascular Risk Assessments
CLAiR provides fast, accurate, non-invasive cardiovascular disease risk assessments using standard retinal images.
Michael Barbella, Managing Editor
04.08.24
Cardiovascular
Medtronic Data Backs Sphere-360 Pulsed Field Ablation Catheter
Subjects showed 81.8% freedom from atrial arrhythmias after one year of follow up.
Sam Brusco, Associate Editor
04.08.24
Cardiovascular
Boston Scientific Begins Study of Farawave PFA Nav Catheter, Software Module
The Farawave Nav PFA catheter adds magnetic navigation to the Farawave PFA catheter for detailed mapping and PFA therapy.
Sam Brusco, Associate Editor
04.08.24
Digital Health
AI, Imaging Agents, Ultrasound Tech Helping to Advance Diagnostic Imaging
Artificial intelligence has great potential to increase the efficiency and accuracy of image analysis.
Michael Barbella, Managing Editor
04.05.24
Cardiovascular
Johnson & Johnson to Acquire Shockwave Medical in $13.1 Billion Deal
Shockwave is the first-to-market provider of intravascular lithotripsy (IVL) tech to treat calcified CAD and PAD.
Sam Brusco, Associate Editor
04.05.24
Materials
Potential Hidden Dangers of Coatings on Limited-Duration Devices
How to avoid the health risks associated with limited-duration device coatings that leach into the body.
Kim Ehman and Sandi Schaible, WuXi AppTec Medical Device Testing
04.04.24
Can Medtech and GLP-1s Peacefully Co-Exist?
Thankfully, one is not mutually exclusive of the other.
Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors
04.04.24
Cardiovascular
AngioDynamics' AlphaVac F18(85) OK'ed to Treat Pulmonary Embolism
The FDA nod broadens the device’s application to non-surgical removal of thrombi or emboli from the venous vasculature.
Sam Brusco, Associate Editor
04.04.24
Cardiovascular
Endospan Releases Early TRIOMPHE IDE Study Results
Data show a low mortality rate, no disabling strokes, paraplegia, or renal failure, and short ICU and hospital lengths of stay.
Michael Barbella, Managing Editor
04.03.24
Cardiovascular
|
Diagnostics
GE HealthCare Rolls Out Caption AI for Vscan Air SL Handheld Ultrasound
Vscan Air SL with Caption AI was designed to lower the threshold for healthcare professionals to capture cardiac images.
Sam Brusco, Associate Editor
04.03.24
Technimark Ireland Achieves MedAccred Program Accreditation
Company manufactures injection-molded packaging and components for the consumer packaging, healthcare, and industrial markets.
Michael Barbella, Managing Editor
04.03.24
Cardiovascular
Concept Medical Granted IDE OK for MagicTouch AVF Trial
This is the fifth U.S. clinical study approval for the MagicTouch portfolio.
Sam Brusco, Associate Editor
04.02.24
Universal Recall Platform Alliance Debuts for Patient Safety
This industry initiative aims to revolutionize how the industry manages recalls with improved speed and accuracy of recalls.
Rachel Klemovitch, Assistant Editor
04.02.24
Cardiovascular
|
Digital Health
FDA Clears First AI to Aid Heart Failure Detection During Routine Check-ups
Developed with Mayo Clinic, Eko Health’s Low EF AI allows clinicians to more accurately assess possible heart failure in at-risk patients.
Michael Barbella, Managing Editor
04.02.24
Cardiovascular
Abbott's TriClip TEER Wins FDA Approval
The TriClip transcatheter edge-to-edge repair system is designed for treating tricuspid regurgitation.
Sam Brusco, Associate Editor
04.02.24
Diagnostics
|
Digital Health
European Regulators OK AI-Enabled Radiology Software
The tool automatically segments the prostate gland in MRI scans and independently identifies pathological changes.
Michael Barbella, Managing Editor
04.02.24
Cardiovascular
EU, British Regulators OK Wearable Cardioverter Defibrillator
The Jewel P-WCD is a water resistant wearable defibrillator designed to detect and treat life-threatening cardiac arrhythmias.
Michael Barbella, Managing Editor
04.01.24
Paul Cohen Hired as MedX Health Medical Spokesperson
Cohen is a dermatologist focused on melanoma awareness.
Michael Barbella, Managing Editor
04.01.24
Olympus Names Julien Sauvagnargues CEO of the Americas
Former OCA CEO, Nacho Abia steps down and President of Medical Systems Group, Richard Reynolds joins the OCA Board.
Rachel Klemovitch, Assistant Editor
03.28.24
FDA Grants Breakthrough Designation to AbSolutions' REBUILD Device
REBUILD has been tested in both animal and human studies with promising outcomes.
Michael Barbella, Managing Editor
03.28.24
Breaking News
Study: One RhinAer Treatment Offers Long-Term Improvement of Chronic Rhinitis
Teleflex Marks Opening of Expanded Manufacturing Facility
Endologix Examining Real-World Performance of its DETOUR System
FDA Clears First Digital Therapeutic for Postpartum Depression
Syed Faridi Joins Catawba Research as Business Development Head
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
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