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Cardiovascular
ConKay Medical Systems Raises $1.8 Million in Seed Funding
The money will support the company's growth and development of its one-size-fits-all annular repair catheter system.
Michael Barbella, Managing Editor
05.02.24
Cardiovascular
HeartBeam Begins Study of its AIMIGo System
Trial aims to demonstrate the equivalence of ECG waveforms between the AIMIGo synthesized 12-lead ECG and a standard 12-lead ECG.
Michael Barbella, Managing Editor
05.02.24
Cardiovascular
Studies Support Favorable Outcomes With Edwards' SAPIEN TAVR
All Edwards TAVR platforms demonstrated excellent paravalvular leak results, according to the data.
Michael Barbella, Managing Editor
05.01.24
Cardiovascular
|
Neurological
Route 92 Medical Gets FDA OK for FreeClimb 54 Reperfusion System
FreeClimb 54 can be used to remove distal clots, should first-line therapies fail to completely remove the clot.
Sam Brusco, Associate Editor
04.30.24
Cardiovascular
WhiteSwell Shares Six-Month Results in its DELTA-HF Study
Data show fewer rehospitalizations for heart failure in the six months after eLym System treatment.
Michael Barbella, Managing Editor
04.29.24
Cardiovascular
HeartSciences' MyoVista Wavelet Technology Now Protected in Canada
The company has been awarded eight utility patents and one design patent in the United States.
Michael Barbella, Managing Editor
04.29.24
Cardiovascular
FDA Approves Abbott's Dissolving Stent for Below-the-Knee Arteries
Esprit BTK is a breakthrough device for people with chronic limb-threatening ischemia below the knee.
Sam Brusco, Associate Editor
04.29.24
Cardiovascular
Roivios Receives FDA Breakthrough Device Designation for JuxtaFlow RAD
The JuxtaFlow RAD device aims to change the treatment paradigm for patients facing kidney disease during cardiac surgery.
Rachel Klemovitch, Assistant Editor
04.26.24
Cardiovascular
iRhythm Collaborates With Epic to Streamline Zio Service Access
The pairing gives healthcare organizations the ability to more efficiently implement Zio services.
Michael Barbella, Managing Editor
04.26.24
Cardiovascular
|
Surgical
Fujifilm Rolls Out First-of-its-Kind Transducer for OPIE for Septal Myectomy
The OPIE transducer is compatible with Fujifilm’s Arietta Precision ultrasound system.
Sam Brusco, Associate Editor
04.26.24
Cardiovascular
HeartSciences Awarded Patent for AI-Enabled Heart Disease Detection Tech
Patent covers use of AI-ECG for any echo measure of diastolic function.
Michael Barbella, Managing Editor
04.25.24
Cardiovascular
European Regulators OK Frontline Medical's Aortic Occlusion Device
The 4 French aortic occlusion device reportedly is the first of its kind to gain MDR approval.
Michael Barbella, Managing Editor
04.25.24
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Cardiovascular
JenaValve Publishes ALIGN-AR Pivotal Trial Results
The company plans to use the trial results in its FDA premarket submission for the Trilogy transcatheter heart valve.
Sam Brusco, Associate Editor
03.28.24
Cardiovascular
|
Diagnostics
|
Neurological
Synaptive Medical's Near-Infrared Fluorescence Visualization Gains FDA Nod
The FDA clearance expands the application of the company's Modus X robotic exoscope.
Sam Brusco, Associate Editor
03.27.24
Cardiovascular
Medtronic's Evolut FX+ TAVR OK'ed for Severe Aortic Stenosis
Evolut FX+ has larger coronary access windows due to a modified, diamond-shaped frame design.
Sam Brusco, Associate Editor
03.27.24
Cardiovascular
Getinge, Cook Medical Ink U.S. Distribution Deal for iCast Covered Stent
Cook Medical will assume iCast’s sales, marketing, and distribution rights in the U.S.
Sam Brusco, Associate Editor
03.26.24
Cardiovascular
|
Digital Health
CardioSignal Raises $10 Million in Series A Financing
Company will use the money to fund further research into its digital heart disease detection technologies.
Michael Barbella, Managing Editor
03.26.24
Cardiovascular
|
Patient Monitoring
Abbott Gets CE Mark for Assert-IQ Insertable Cardiac Monitor
Assert-IQ ICM helps doctors monitor people's heart rhythms remotely for up to six years.
Sam Brusco, Associate Editor
03.25.24
Cardiovascular
J&J's Biosense Webster Submits Varipulse Pulsed Field Ablation for FDA Approval
The submission was supported by data from the company’s admIRE study.
Sam Brusco, Associate Editor
03.25.24
Cardiovascular
Abbott Enrolls 1st Patient in Navitor TAVI Trial for Low and Intermediate Surgical Risk
The Navitor TAVI features a NaviSeal fabric cuff that reduces blood backflow around the heart valve.
Sam Brusco, Associate Editor
03.22.24
Cardiovascular
|
Digital Health
Sensydia Finishes Fifth Study for Heart-Sound AI
The study completion is a key milestone on the path to delivering the first device for non-invasively and accurately measuring pulmonary pressure.
Michael Barbella, Managing Editor
03.22.24
Cardiovascular
J&J's Abiomed Recalls Impella Left-Sided Heart Pumps for Perforation Risk
The pump catheter may perforate the wall of the heart’s left ventricle.
Sam Brusco, Associate Editor
03.21.24
Breaking News
Elekta Acquires IP for Philips' Pinnacle Treatment Planning System
LifeMD and Withings Health Solutions Offers Real-Time Weight Loss Monitoring Solution
ConKay Medical Systems Raises $1.8 Million in Seed Funding
Owlet's Dream Sock OTC Infant Pulse Oximeter OK'ed in Europe
HeartBeam Begins Study of its AIMIGo 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
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