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Home » Topics » Devices » Submissions and Approvals

Submissions and Approvals
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Owlet’s Baby Sock and Laser Pediatric Port Wine Stains Get FDA Clearances

July 11, 2023
Owlet previously received a warning letter for marketing the device without a 510(k) clearance. Read More

Owlet’s Baby Sock Recovers From Warning Letter, Laser Cleared for Pediatric Port Wine Stains

July 6, 2023
The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval. Read More

FDA Drug and Device Approvals — June 2023

July 6, 2023
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More

ClinicalTrials.Gov Website Update Goes Live

June 23, 2023
For now, users will be able to switch between the new and “classic” versions of the website. Read More

Modernized ClinicalTrials.Gov Website Goes Live

June 21, 2023
Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More

OCD Motor Threshold Cap Receives 510(k) Clearance From FDA

June 15, 2023
Neuronetics has received FDA 510(k) clearance for its NeuroStar motor threshold (MT) cap to treat obsessive-compulsive disorder (OCD). Read More

Device Innovations Abound in Phones that Act Like Stethoscopes and Virtual Reality Surgery

June 13, 2023
Phone software captures heart and lung sounds when held to the chest. Read More

Cue Health’s First-of-its-Kind COVID-19 Home Test Gets FDA Authorization

June 12, 2023
The FDA said this test is an example of the agency’s continued work with test developers that want to market their products beyond emergency use authorities. Read More

From Phones that Act Like Stethoscopes to VR Surgery, Device Innovations Abound

June 9, 2023
Medical devices continue to take advantage of the technological advances we see in every part of our lives, from phones to virtual reality headsets, with several new devices seeing FDA clearances in the past few weeks. Read More

FDA Drug and Device Approvals — May 2023

June 8, 2023
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling. Read More

First-of-its-Kind COVID-19 Home Test Gets FDA Authorization

June 7, 2023
Cue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first traditionally authorized at-home test for any respiratory illness. Read More

Ezra Sees 510(k) Clearance for Ezra Flash AI Product for Faster, Better MRI Images

June 5, 2023
The company’s preventive full-body scans have uncovered potential cancers and other disease states. Read More
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