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BioWorld - Friday, February 27, 2026
Home » India

Articles Tagged with ''India''

Datar gets FDA breakthrough device designation for brain tumor blood test

Jan. 9, 2023
By T.V. Padma
The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors.
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India releases classification system for 48 devices in oncology

Oct. 21, 2022
By T.V. Padma
In a new notification issued in October 2022, India’s regulators have updated its classification of 48 devices used in oncology.
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Pancreas illustration

Diabetes market in India expected to boom

July 29, 2022
By David Ho
Med-tech manufacturers can expect the market for diabetes care-related products, ranging from insulin pens to smart devices, to rise in India. India already has the second-largest number of adults with diabetes globally, after China.
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Map, flag of India

India updates regulations on licenses as part of regulatory overhaul

June 9, 2022
By David Ho
India’s regulators have made more moves in recent times as part of its larger and ongoing movement to regulate medical devices in its country. The Ministry of Health and Family Welfare has just finalized its regulations over the licenses of medical device manufacturers and suppliers.
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Blister drug pack atop globe

‘East to West’ movement of trial data raising diversity, quality concerns

May 24, 2022
By Mari Serebrov
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
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Blister drug pack atop globe

‘East to West’ movement of trial data raising diversity, quality concerns

May 23, 2022
By Mari Serebrov
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
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Mohit Kumar (left) and Vatsal-Singhal (right)

Ultrahuman acquires Lazyco to develop preventive care wearable

April 22, 2022
By David Ho
Metabolic health platform Ultrahuman Healthcare Ltd. has acquired consumer wearable company Lazy Design Pvt Ltd. India (known as Lazyco) to expand the biomarkers complementing its current wearable, the Ultrahuman M1.
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03-30-Qure-qremote-mock-up.png

Qure eyes US and Europe expansion for AI imaging diagnostics portfolio

March 30, 2022
By Catherine Longworth
Health tech firm Qure.ai Technologies Private Ltd. has secured a $40 million investment from investors including Novo Holdings and Healthquad to expand its portfolio of automated artificial intelligence (AI)-based imaging diagnostics. The company’s suite of technologies incorporates deep learning and AI to interpret radiology images such as X-rays, CTs, and ultrasounds in less than a minute.
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Novavax’s COVID-19 vaccine granted EUA for adolescents in India

March 29, 2022
By David Ho
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
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Novavax’s COVID-19 vaccine granted EUA for adolescents in India

March 23, 2022
By David Ho
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
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