The U.S. Food and Drug Administration has announced an immediate review of clinical trials that involve the transfer of American citizens' living cells to China and other hostile countries for genetic engineering. This urgent action comes amid increasing concerns that trial participants may not have been fully informed about the...
India’s Role in Medical Devices to Blossom with AI Integration
Artificial Intelligence (AI) is being incorporated into various medical devices, including imaging machines for faster scans and lesion detection, wearables for heart arrhythmia detection, and software systems for predicting sepsis risk in hospitals. This trend has prompted regulators to clarify their positions on AI in medical devices. As this happens,...
German Firm Miltenyi Biotec to Launch Operations in India
German firm Miltenyi Biotec, will launch operations in India with its first office and invest in setting up the Miltenyi Innovation and Technology Center as a Cell and Gene Therapy (CGT) Center of Excellence in Hyderabad. The company aims to enable local development and manufacturing in India to drive affordable...
ReShape Lifesciences Signs Manufacturing Agreement with India’s Biorad Medysis
In Septemeber, Irvine, CA-based ReShape Lifesciences signed an exclusive, royalty-bearing license agreement with Biorad Medysis, Pvt. Ltd. of Mumbai India to manufacture, commercialize and distribute the Obalon® Gastric Balloon System in India, Pakistan, Bangladesh, Nepal, Bhutan, Sri Lanka, and the Maldives. The non-surgical, minimally invasive, Obalon System approved by the...