Concept Medical receives 4th IDE approval from USFDA
The company has already received three other pivotal IDE approvals for its SCB Magic Touch family of products for the coronary…
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USFDA approval
Cognota receives USFDA approval for BP monitor device
With the regulatory approval, company can now export its blood pressure monitor devices to the US, Europe, and other overseas…
Wysa receives FDA Breakthrough Device Designation for its mental health conversational agent
The device delivers cognitive behavioral therapy (CBT) via a smartphone-based conversational agent to reduce the symptoms of…
USFDA authorises first COVID-19 diagnostic test using breath samples
Test provides results in less than three minutes
Control Print receives USFDA approval for distribution of 3 ply surgical masks in USA
The 510(k) certification endows The Mask Lab, the marketing authorisation needed to supply the US healthcare and business…
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Healthium Medtech receives USFDA registration for its manufacturing facility in Andhra Pradesh
With this announcement, the Sri City plant becomes the fourth USFDA registered Healthium facility
FDA approves new imaging drug to help identify ovarian cancer lesions
The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect…
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory MCL
Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the…