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 Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. FDA reports Enspryng is the third approved treatment for the disorder.

August 17, 2020

Masimo PVi® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients

PVi, or pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

August 14, 2020

Market Ready Swoop Portable MRI System Receives 510(k) FDA Clearance

This clearance for the Swoop™ Portable MRI System market-ready device covers enhanced imaging and software, and expands Hyperfine’s brain imaging indication to include patients aged 0 to 2.

August 13, 2020

RapidAI Receives FDA Clearance of Rapid LVO For Identification of Suspected Large Vessel Occlusions

RapidAI makes the most-widely used stroke imaging software for patient care, research, and clinical trials—helping hospitals around the world save time, money, and lives.

August 13, 2020

FDA Posts Additional Postmarket Information for Essure

"The FDA continues to take concerns about Essure very seriously. Consistent with our previous updates, we are committed to continuing our postmarket evaluation of this device and providing updated information periodically.

August 11, 2020

PLATEAU-X Ti Lateral Lumbar Spacer System Receives FDA 510(k) Clearance

PLATEAU-X Ti launch furthers our commitment of offering micro invasive solutions that are designed to save time, save money, and accelerate patient recovery,” said Mariusz Knap, Sr. Vice President of Sales and Marketing for Life Spine.

August 11, 2020

Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test

The high throughput test will be available in the Fall with next-day turnaround time and will enable Helix to scale its capacity to 100,000 tests per day.

August 10, 2020

Ortho-R Receives FDA Regulatory Designation and Jurisdictional Assignment

Ortho-R is designated as a Drug/Biologic combination product, by the FDA Office for Combination Products. The jurisdictional assignment for Ortho-R will be the Center for Biologics Evaluation and Research (CBER). The news was announced today by Ortho Regenerative Technologies. On March 26th, 2020, a pre-Request for Designation application was submitted to the FDA's Office for Combination Products to seek for guidance on designation status for Ortho-R product, a Chitosan-based matrix biopolymer* mixed with Platelet Rich Plasma (PRP) to form an...

August 6, 2020

FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

"The FDA is finalizing guidance today that will help protect public health by reducing infants' exposure to inorganic arsenic, which has been associated with neurodevelopmental effects.

August 5, 2020

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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.