India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country.
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country, varieties of which have led to the deaths of scores of children in late 2022.
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.
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.
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.
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.
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.
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.
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.
