Category: FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

RapidAI Secures FDA Clearance for...

May 6, 2024

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”

Intuity Medical’s POGO Automatic ®,...

May 2, 2024

Recognized by healthcare professionals for its user-friendly design which can improve testing compliance, POGO Automatic is endorsed as the ideal solution for many diabetes patients by Rosemarie Lajara, MD, an endocrinologist with Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas

RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

May 6, 2024

ivWatch SmartTouch™ Sensor Receives FDA Clearance

Designed with direct clinician input, SmartTouchTM is a single-use sensor that is cleared for all patient age groups. The new miniaturized and disposable sensor adds functionality options for IV site placement, particularly for neonates, for monitoring IV sites of more active patients, and for longer dwell times.

July 7, 2020

LINQ II Insertable Cardiac Monitor Receives FDA Clearance and CE Mark

LINQ II™ insertable cardiac monitor is a small (one-third the size of a AAA battery), wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope (fainting) and chest pain, thereby requiring long-term monitoring or ongoing management.

July 7, 2020

Getinge Receives 510(k) Clearance for Servo-air® Mechanical Ventilator

Servo-air® is a high performing ventilator intended for adult and pediatric patients and includes both Invasive and Non-Invasive (NIV) ventilation modes, including High Flow Therapy and Servo Compass options.

July 7, 2020

Carag Receives U.S. FDA IDE Approval for Its Carag Bioresorbable Septal Occluder

The CE-marked Carag Bioresorbable Septal Occluder is the first-ever transcatheter septal occluder with bioresorbable, metal-free framework.

July 1, 2020

IlluminOss Medical Receives FDA Clearance for Photodynamic Bone Stabilization System

The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market.

June 30, 2020

Envoy Medical Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant

Unlike existing traditional cochlear implants that are partially implanted and have an external microphone and processor, if approved by the FDA, the Acclaim would be the first-of-its-kind cochlear implant without any external components to offer unique benefits to users and hopefully increase cochlear implant adoption and user compliance across the globe.

June 29, 2020

Orthofix Announces FDA Clearance and First Patient Implants of FIREBIRD SI Fusion System for Low Back Pain

The FIREBIRD SI Fusion System is implanted through a minimally invasive surgery that typically can be performed in about an hour and may lead to less time at the hospital and a faster recovery than a traditional sacroiliac joint fusion surgery. The procedure with the FIREBIRD SI Fusion System involves inserting two to four bone screws across the SI Joint to stabilize during the fusion process.

June 29, 2020

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

The new LUX-Dx™ Insertable Cardiac Monitor System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

June 29, 2020

Percept PC Deep Brain Stimulation System with BrainSense Technology Receives FDA Approval

BrainSense™ technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder.

June 25, 2020