US FDA issues EUA for molecular point-of-care test for detection of COVID-19 by Abbot
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US Food and Drug Administration
US FDA provides EUA for PerkinElmer’s new Coronavirus RT-PCR test
The test kit is marketed as IVD device by meeting requirements of European In Vitro Diagnostic Directive, is available in over 30…
US FDA clears Israeli startup Sight Diagnostics’ finger prick blood test
The regulator’s nod means that laboratories that run relatively lesser tests on a day to day basis may also be able to conduct the…
FDA authorises first interoperable, automated insulin dosing controller device
The device is designed to allow more choices for patients looking to customise their individual diabetes management device system…
FDA authorises test to aid in newborn screening for DMD
The GSP Neonatal Creatine Kinase-MM kit works by measuring concentration of a type of protein called CK-MM, which is part of a…
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FDA authorises marketing of diagnostic test
The cobas vivoDx MRSA diagnostic test may allow healthcare professionals to evaluate patients for colonisation with MRSA bacteria…
FDA launches app for healthcare professionals
To report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
The US Food and Drug…
FDA approves system for delivery of tympanostomy tubes
The system enables delivery of ear tube to patients under local anaesthesia in a physician’s office setting, therefore avoiding…
FDA approves first contact lens indicated to slow progression of near-sightedness in children
MiSight contact lens is single use, disposable, soft contact lens that is discarded at end of each day and is not intended to be…
Biotin can interfere with certain lab tests, cause incorrect results that may go undetected: FDA
Biotin interference causes falsely low result for troponin, clinically important biomarker to aid in diagnosis of heart attacks