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.

Intuity Medical’s POGO Automatic®, the...

May 2, 2024

Intuity Medical, Inc., a medical technology company...

XT-Thrive® Drug Master File (DMF)...

April 17, 2024

X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.

Intuity Medical’s POGO Automatic®, the First and Only FDA-Cleared Automatic Blood Glucose Monitor, Now Covered by Medicare Part B

May 2, 2024

Intuity Medical, Inc., a medical technology company committed to making it easier to live with diabetes, announced today that its POGO Automatic® Blood Glucose Monitoring (ABGM) system, featuring one-step testing, is now covered by Medicare Part B. This decision expands access to the innovative monitor for the 16.5 million seniors age 65 and up living with diabetes. The Centers for Medicare and Medicaid Services (CMS) created two new coverage codes specifically for POGO Automatic, recognizing this new and significantly different technology compared to traditional blood glucose meters (BGMs). POGO Automatic...

Zilia Receives FDA Clearance for its Zilia Ocular™ FC Retinal Camera

"Receiving this first FDA clearance for our retinal camera is not just a milestone, it's a leap forward in our quest to safeguard the vision of millions," said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. "We're now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions."

November 29, 2023

Brainomix Targets US Expansion with the Launch of its Cutting-Edge Stroke AI Platform Following Series of FDA Clearances

The recent FDA clearances included Brainomix 360 e-CTP and Brainomix 360 e-MRI, both software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to hospital more than 6-12 hours after stroke onset.

November 22, 2023

GE HealthCare Announces New Version of Digital Expert Access, the First FDA 510(k)-Cleared Device to Enable Remote Patient Scanning, and Exclusive Distribution Agreement with IONIC Health

IONIC Health’s 510(k)-pending nCommand Lite technology is designed to include vendor-agnostic remote scanning capabilities. This strategic collaboration’s goal is to enable GE HealthCare to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems and patients around the globe.

November 21, 2023

Senhwa Biosciences Received US FDA IND Approval for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection

Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT.

November 21, 2023

FloSpine Revolutionizes Treatment for Spinal Stenosis with FDA Clearance of KeyLift™ System

"This is the culmination of years of research and development to deliver a medical device that helps improve the lives of patients suffering from spinal stenosis. Our recent move to larger premises in the Research Park at FAU will allow us to train our surgical and distribution partners to become increasingly competitive in the spinal implant device market,” said Peter Harris, founder and CEO of FloSpine.

November 1, 2023

Chimeric Therapeutics Reports FDA Clearance of IND Application for CHM 2101 | A Novel CDH17 CART T Cell Therapy for Advanced Gastrointestinal Cancers

Anticipated to be the first CDH17 CAR T cell therapy to enter the clinic. Phase 1A clinical trial to initiate patient enrolment in 2024. Phase 1A clinical trial will enroll patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours.

October 31, 2023

iOnctura Announces FDA Clearance of IND Application for Roginolisib, a First-in-class Allosteric Modulator of PI3Kδ

Roginolisib (IOA-244) is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer in which malignant (cancer) cells form in the uveal tract of the eye. When the cancer metastases, which it does in approximately 50% of patients, there are limited treatment options and projected overall survival is only a year.

October 31, 2023

Integrum’s OPRA™ Implant System Gets FDA Approval for Clinical Study on Below-knee Amputations

The study will be performed by the Walter Reed National Military Medical Center.

October 30, 2023

Medtronic Receives FDA Approval for Extravascular Defibrillator to Treat Abnormal Heart Rhythms, Sudden Cardiac Arrest

FDA approval of the Medtronic Aurora EV-ICD system includes the system's proprietary procedure implant tools, and was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine. In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States.

October 23, 2023