Inito clears US FDA regulatory pathway for fertility monitor
Becomes first Indian home diagnostic device startup to achieve the milestone
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US FDA
US FDA clarifies about Nov 2019 revisions on insulin pen packaging and dispensing
Strongly encouraged insulin pen manufacturers to consider developing smaller carton sizes to better accommodate variable insulin…
US FDA authorises first COVID-19 antigen test where results can be read directly from testing card
Cautions that negative results from antigen tests may need to be confirmed with a molecular test prior to making treatment…
FDA multiple-function device products update particularly affects telehealth: GlobalData
As a result of the new regulations, device manufacturers will implement separation and support segregation of device functions…
Siemens Healthineers bags first US FDA EUA for semi-quantitative SARS-CoV-2 IgG antibody test
Siemens Healthineers has received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test. Like all…
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Unichem Laboratories gets USFDA nod to market muscle spasm tablets
The tablets will be commercialised from the company's Goa plant
Drug firm Unichem Laboratories has received approval from the…
73 per cent doctors cite ‘antiviral agents’ as most effective therapy for treating COVID-19: Course5…
Global fight against COVID-19 has found powerful tools in form AI, ML, big data, IoT technologies that are playing key role in…
Abbott receives FDA approval for its ICD, CRT-D devices
The devices bring new benefits to patients with heart rhythm disorders, including patient-preferred design without compromising…
Drug firms in India recall products from US
While Lupin and Marksans Pharma are recalling diabetes drug, Aurobindo and Alembic are recalling psychiatric medication in the US…
Transasia Bio-Medicals receives US FDA registration for in-vitro diagnostic instruments manufactured…
Transasia’s ‘Made in India’ products which are currently exported to over 100 countries will now also be available in the US