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Boston Scientific Has a Class I Embolization Tech Recall
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Diagnostics
Avicenna.AI Receives FDA Clearance for Two Healthcare AI Solutions
The company’s algorithms enable incidental detection of pulmonary embolism and automatic assessment of stroke severity.
Rachel Klemovitch, Assistant Editor
03.27.24
Diagnostics
Qure.ai Receives FDA Clearance for AI-Powered Tuberculosis Solution
qSpot-TB device is the company’s fourth FDA-cleared device.
Rachel Klemovitch, Assistant Editor
02.07.24
Hologic Receives FDA Clearance for Genius Digital Diagnostics System
First FDA-cleared digital cytology system.
Rachel Klemovitch, Assistant Editor
02.05.24
Neurological
NeuroOne Receives FDA Clearance for Ablation System
New technology offers potential for shorter hospital stays, fewer surgeries, and improved patient outcomes.
Charles Sternberg, Associate Editor
12.11.23
Diagnostics
Annalise.ai Earns FDA Clearance and Breakthrough Device Designation
Bolsters its U.S. portfolio to a total of ten FDA-cleared findings.
Charles Sternberg, Associate Editor
09.13.23
Former Employee of Medical Device Firm Admits Forging FDA Clearance Letters
Peter Stoll shepherded a high-speed surgical drill and reusable sterilization container through the FDA 510(k) process.
Michael Barbella, Managing Editor
07.21.23
Diagnostics
|
Surgical
Lumendi Nabs FDA Clearances for 2 New Devices
DiLumen EZ1 and C1 are part of a growing platform of accessories.
Sam Brusco, Associate Editor
02.17.23
New FDA Clearance Granted to RapidAI's Intracranial Hemorrhage Triage Tool
New version of ICH reduces notification fatigue with a near perfect false positive rejection rate.
Michael Barbella, Managing Editor
01.19.23
OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
The RevoLix's Continuous Wave and Pulse modes allow complete surgical customization of laser therapy parameters.
Michael Barbella, Managing Editor
07.01.22
XACT ACE Robotic System Wins Expanded FDA Clearance
The System combines image-based procedure planning and real time monitoring with hands-free precise robotic insertion and non-linear steering.
Michael Barbella, Managing Editor
06.27.22
Cardiovascular
Access Vascular Receives FDA Clearance for HydroPICC Catheter
Single- and dual-lumen biomaterial catheters allow hospitals to reduce thrombosis and vascular access complications for majority of PICC applications.
Michael Barbella, Managing Editor
06.14.22
Guard Medical Gains FDA Clearance for Additional NPseal Sizes
NPseal delivers the same negative pressure wound therapy as more expensive and complex NPWT devices.
Michael Barbella, Managing Editor
04.19.22
Patient Monitoring
LivaNova Receives FDA Clearance and CE Mark for Essenz Patient Monitor
Initiates targeted commercial launch of the monitor for cardiopulmonary bypass procedures.
Charles Sternberg, Associate Editor
04.11.22
RedDress’ ActiGraft System Receives New FDA Clearance
ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.
Globe Newswire
09.22.21
Cardiovascular
Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades
Introduces advanced new mapping algorithms into the AcQMap 3D imaging and mapping system.
Acutus Medical
08.12.21
Getinge Receives FDA Clearance for Multiple Products
Expands its Servo ventilator platform with new functionalities and options.
Charles Sternberg, Assistant Editor
04.22.21
J&J’s Veritas Vision System Receives FDA Clearance and CE Mark
Next-gen phacoemulsification innovation allows surgeons to guide through any lens density with less surge and more stability.
Charles Sternberg, Assistant Editor
04.21.21
Acutus Medical Receives FDA Clearance of AcQCross
Product family targets more than 300,000 annual U.S. electrophysiology and structural heart procedures.
Michael Barbella, Managing Editor
04.15.21
Diagnostics
Optellum Receives FDA Clearance for Virtual Nodule Clinic
Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.
Charles Sternberg, Assistant Editor
03.23.21
Eitan Medical Receives FDA Clearance for Sapphire Infusion System
Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.
Eitan Medical
01.20.21
AtriCure Receives FDA Clearance to Expand its Labeling for Cryo Nerve Block Therapy
The expansion includes adolescent patients who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall.
Business Wire
01.20.21
Neurological
BioSerenity Achieves FDA Clearance for Wearable Device System
Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.
PRNewswire
01.07.21
Hyperfine Research Receives FDA Clearance for Swoop Portable MRI System
Technology defines new product category for accessible, cost-effective point-of-care magnetic resonance imaging.
Business Wire
10.05.20
Digital Health
HD Medical Awarded FDA Clearance for HD Steth
Intelligent stethoscope with integrated ECG delivers instant cardiac insights.
Business Wire
09.11.20
Gynesonics Receives FDA Clearance to Market Next-Generation Sonata System 2.1
Early launch in Europe contributes to significant procedural growth.
Business Wire
07.29.20
Beckman Coulter Receives FDA Clearance for Automated Microplate System
Processes up to 300 samples per hour with a maximum of 12 tests per sample.
PRNewswire
07.23.20
Magnolia Medical Secures FDA Clearance for Expanded Steripath Gen2 Products
Devices become the first and only products indicated to reduce blood culture contamination.
PR Newswire
05.14.20
Mauna Kea's Next-Generation Cellvizio Platform Receives FDA Clearance, CE Marking
The new platform includes significant improvements and will enable major innovations, such as integrating easily with robotic systems.
Business Wire
05.13.20
CHF Solutions Receives FDA Clearance for Aquadex SmartFlow System
The system provides a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).
Globe Newswire
04.30.20
Kurin Receives FDA 510k Clearance for Its Push-Button Needle
Company's technology automatically and passively sidelines potential contaminants during blood culture collection.
Business Wire
04.24.20
FDA Clears Bimini Health Tech's Dermapose Refresh Fat Transfer
Dermapose Refresh is an all-in-one microfat transfer system.
PR Newswire
04.22.20
CloudCath Announces $12 Million Series A Financing
Funds will be used to advance commercialization of technology enabling remote, real-time complication monitoring for at-home dialysis.
Business Wire
04.07.20
R&D & Design
Why Outsourcing Is in: Piecing Out Projects Makes Sense
Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.
Dawn A. Lissy, President & Founder, Empirical
04.01.20
Atlantic Therapeutics Receives FDA Clearance for Over-the-Counter Use of INNOVO
Product is now available to order without a prescription for treating bladder weakness in women.
Business Wire
03.20.20
Alydia Health Completes Enrollment in Pivotal PEARLE IDE Study
The investigational Jada System is designed to treat abnormal postpartum uterine bleeding and hemorrhage following childbirth.
Business Wire
03.19.20
Diagnostics
Survey: Lack of Access to Diagnostic Tests Has Driven Spread of Coronavirus
CDC reports that more than 22,000 specimens or nose swabs have been taken in the U.S. since the outbreak began, far below other developed countries.
GlobalData
03.17.20
Diagnostics
|
Software & IT
FDA OKs behold.ai’s AI Algorithm for Radiology Triage
Alerts radiologists of a collapsed lung as soon as the X-ray image is captured.
GlobeNewswire
03.12.20
Diagnostics
Coronavirus Detectable With IDbyDNA Explify Respiratory Test
Explify Respiratory is a validated laboratory developed test for respiratory pathogens, including human coronaviruses.
Business Wire
03.10.20
Neurological
Neuronetics' TMS Device for Bipolar Depression Wins Breakthrough Status
Could potentially provide more effective treatment with limited safety concerns.
GlobeNewswire
03.06.20
Cardiovascular
|
Surgical
FDA OKs Stereotaxis' Genesis Robotic Magnetic Navigation
Robotic navigation of magnetic ablation catheters treats heart rhythm disorders.
GlobeNewswire
03.06.20
Chronic Disease
FDA OKs Aerin's Nonsurgical Chronic Rhinitis Treatment
RhinAer disrupts signals that cause runny nose, post-nasal drip, congestion, and chronic cough.
Business Wire
03.05.20
Cardiovascular
FDA OKs Access Vascular's Next-Gen HydroPICC
Biomaterial platform in peripherally inserted ventral catheter (PICC) may virtually eliminate clot accumulation.
PR Newswire
03.04.20
Tivic Health's ClearUP Sinus Relief Gains CE Mark
ClearUP uses gentle microcurrent waveforms to reduce allergy-related sinus pain.
PR Newswire
03.04.20
Cardiovascular
|
Patient Monitoring
Bardy Diagnostics Launches the 14-Day Carnation Ambulatory Monitor Patch
Data show the BardyDx CAM Patch identified 40 percent more arrhythmias and resulted in better, more informed clinical decision-making.
PR Newswire
03.04.20
Patient Monitoring
FDA Clears Masimo for Continuous RRp Monitoring
Both continuous and spot-check RRp are now available in the US.
Business Wire
03.02.20
Chronic Disease
Tandem's Basal-IQ Gains FDA Clearance as iAGC
This is the second system to receive interoperable automated glycemic controller designation by the FDA.
Tandem Diabetes Care
03.02.20
Chronic Disease
FDA OKs InPen for Fixed Dosing, Meal Estimation
New bolus calculator considers each user's current glucose level and active insulin.
PR Newswire
02.28.20
Cardiovascular
|
Surgical
FDA OKs LivaNova's 3T Heater-Cooler Device Modification
Modification includes installation of 3T Aerosol Collection Set, testing that demonstrates effectiveness of operating instructions.
Business Wire
02.26.20
Diagnostics
Emagine Solutions Technology Receives FDA Clearance
The clearance enables the launch of the company’s VistaScan mobile ultrasound platform.
Emagine Solutions
02.25.20
Former Cantel Medical CEO to Take Helm at Ivenix
New chief executive has more than 25 years of global healthcare experience.
Business Wire
02.20.20
Breaking News
GE HealthCare Rolls Out New AI-Powered Ultrasound for Women's Health
Otolith Labs Expands Leadership Team
AtriCure Rolls Out cryoSPHERE+ Probe for Post-Op Pain Management
Patient Enrollment Complete in Study of Route 92 Medical's HiPoint Reperfusion Catheters
Boston Scientific Has a Class I Embolization Tech Recall
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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