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.
Naviswiss Receives FDA 510k Clearance for Naviplan
The Naviplan hip application is CT-based and assists the surgeon in the optimal positioning of the joint implants, automatic 3D segmentation and advanced image processing.
Audicus Applauds FDA Announcement To Move Closer To Making Hearing Care More Accessible To Millions Of Americans
The proposed rule will allow for certain classes of hearing aids to be sold directly to consumers without the need for a fitting from an Audiologist, increasing accessibility to hearing care for the 37.5 million American adults with some form of hearing loss.
DreaMed Launches its FDA-Cleared Diabetes Management Platform with a Leading U.S. Children’s Hospital
Advisor Pro is the first decision support system to receive FDA clearances for Type 1 and Type 2 diabetes treatments – for pediatrics and adults.
HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy
Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.
Withings Announces the FDA Clearance of ScanWatch — Its Most Medically Advanced Hybrid Smartwatch
ScanWatch becomes the first wearable to simultaneously be cleared to record ECG & SpO2 measurements.
Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems
The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.
Alpha Tau Receives FDA’s Breakthrough Device Designation for the RX of Recurrent Glioblastoma Multiforme
"As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA's Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients.
FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin
These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and increase public health protection by focusing on areas of higher risk.
SyncThink Receives Second FDA Clearance for EYE-SYNC Platform; the First Mobile, Rapid Test for Concussion
EYE-SYNC previously received the prestigious Breakthrough Device Designation from the FDA in 2019, following the initial clearance and commercialization of the technology platform in 2017.
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