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.

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.

Simpson Interventions Receives FDA Breakthrough...

April 11, 2024

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.

XT-Thrive® Drug Master File (DMF) Accepted by the FDA | Reports X-Therma

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.

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs: Statement from FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D.

Nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply.

September 1, 2020

MiniMed 770G Insulin Pump System with Smartphone Connectivity Receives FDA Approval

MiniMed™ 770G hybrid closed loop system expands the benefits of hybrid closed loop therapy to younger children living with type 1 diabetes and makes it easier to access and share real-time CGM and pump data.

September 1, 2020

FDA Grants De Novo Authorization for Theranova Dialyzers Enabling HDx Therapy

Theranova was designed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa)

August 31, 2020

SpaceStation MRI Receives FDA Clearance

SpaceStation MRI allows Space® infusion pumps to continuously deliver medications to patients within the MRI suite.

August 27, 2020

Healeon Announces FDA 510(k) Clearance for Duet Office-Based Blood Separation and Concentration System

The Healeon Duet enables safe, quick, and easy separation of blood components into customizable platelet concentrations and is designed for use within the practitioner's office.

August 27, 2020

Orbit Subretinal Delivery System Receives FDA Clearance: Indicated for Microinjection into the Subretinal Space at the Back of the Eye

Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space at the back of the eye.

August 25, 2020

Guardant Health Receives FDA EUA for its Guardant-19 Next Generation Sequencing-Based COVID-19 Test

Guardant Health reports the test is being offered to their employees and select partner organizations through the company’s CLIA-certified clinical laboratory.

August 24, 2020

LumiraDx Receives FDA EUA for the LumiraDx SARS-CoV-2 Antigen Test

LumiraDx SARS-CoV-2 antigen test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application in symptomatic patients. In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement versus PCR in patients tested within 12 days of the onset of symptoms, making it the fastest, most sensitive antigen point of care test currently commercially available.

August 20, 2020

World’s First Fully Transparent Surgical Mask Receives FDA (510k) Clearance

ClearMask™ is the world's first FDA-cleared, fully transparent surgical mask that can be used in hospitals, clinics, schools, retail, hospitality, and other settings.

August 18, 2020