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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.
Svelte Medical Systems Receives FDA Approval For SLENDER IDS® And DIRECT RX® Bioresorbable Coated Drug-Eluting Stent Systems
SLENDER IDS®, an ‘all-in-one’ integrated delivery system featuring Asahi guide wire technology, and DIRECT RX®, a workhorse rapid-exchange delivery system, are low profile DES systems designed to enhance trans-radial intervention (TRI) and indicated by the FDA for use with direct stenting.
Cooler Heads Receives FDA Clearance To Help Save Cancer Patients’ Hair
A revolutionary scalp cooling device to help cancer patients undergoing chemotherapy save their hair. All the more impressive is that Cooler Heads achieved this milestone after raising less than $1.5 million in venture capital funding.
FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases
This field is rapidly evolving, and antisense oligonucleotide drugs are the most advanced in this space
Revival Health Inc. Announces 9 Mil FDA EUA Authorized COVID-19 Rapid At-home Tests
Revival Health Inc. (Revival), a leading global medical device manufacturer, announced the availability of over 9 million units per month of the EUA authorized...
ImmersiveTouch Wins FDA Clearance For New Suite of Medical Diagnosis and Treatment Planning Tools
ImmersiveTouch’s COO, Jay Banerjee says, “adding this additional FDA 510(k) Clearance for medical diagnosis and treatment planning to our portfolio just strengthens what ImmersiveTouch can offer surgeons.”
Cardiologs’ AI Receives 510(k) Clearance for Pediatric Use
The new model, now supported by more than 20 million EKG recordings, was used to evaluate a global sample of 10,000 EKG readings from patients in various age groups.
WellAir: New FDA-cleared Indoor Cleaning Device 99.9% Effective Indoor Pathogens Including COVID
WellAir recently launched the Defend NV 400, an FDA-cleared Class II medical device that is 99.9% effective at inactivating airborne pathogens
FDA Expands Eligibility for COVID-19 Vaccine Boosters
"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Peter Marks, M.D., Ph.D.,
Blackrock Neurotech’s MoveAgain Brain-Computer Interface System Receives Breakthrough Device Designation from the FDA
The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that can improve the lives of people with irreversibly debilitating diseases or conditions.
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