BioTechnology
When developing Vuity, Allergan developed 16 eye drop formulations before settling on the now FDA-approved solution.
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All posts tagged "Regulatory"
Digital Health
MetaMe received FDA clearance for its first digital therapeutic on Tuesday. It uses behavioral therapy to help alleviate abdominal pain symptoms for patients with...
Digital Health
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k)...
Digital Health
Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420.
Emerging Technologies
Bexson Biomedical announced today that it received pre-investigational new drug guidance from the FDA for its ketamine compound therapy.
CE Mark
PFA is currently being investigated as an alternative to cryo and radiofrequency ablations, which ablate tissue by either extreme cold or extreme heat.
Diagnostics
HeartVista has received US Food and Drug Administration (FDA) 510(k) clearance to deliver its AI-assisted One Click magnetic resonance imaging (MRI) acquisition software on...
Artificial Intelligence
The agency says stakeholders can use the principles to tailor and adopt good practices from other sectors to be used in the health tech...
BioTechnology
The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months while, if necessary, supplemental ranibizumab treatment...
CE Mark
Hugo will be released as soft tissue procedures have been limited due to the shutdown of non-emergency care throughout the pandemic.
