Rare Diseases at FDA

Rare Diseases at FDA

Over 7,000 rare diseases affect more than 30 million people in the United States. Many rare conditions are life-threatening and most do not have treatments. Drug, biologic, and device development in rare diseases is challenging for many reasons, including the complex biology and the lack of understanding of the natural history of many rare diseases. … Read more

AI-integrated medical technology advancements reshaping diagnostic procedures, patient care – ET HealthWorld

AI-integrated medical technology advancements reshaping diagnostic procedures, patient care – ET HealthWorld

London: Advancements in medical technology, particularly the integration of artificial intelligence (AI), are reshaping diagnostic procedures and patient care. With the burgeoning market for AI-driven diagnostics expected to surpass $908.7 billion in 2030, innovative AI-powered diagnosis apps signify a transformative shift in healthcare delivery. These technologies promise real-time insights, personalised treatment plans, and cost-effective solutions, … Read more

DeepTek.ai receives US FDA clearance for its Chest X-ray AI solution – CXR Analyser – ET HealthWorld

DeepTek.ai receives US FDA clearance for its Chest X-ray AI solution – CXR Analyser – ET HealthWorld

Pune: DeepTek.ai has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Chest X-ray AI solution, the CXR Analyser. The technology uses deep learning algorithms to detect abnormalities in chest X-rays. It identifies, categorises, and highlights suspicious areas automatically, aiding clinicians in making precise interpretations. The Chest X-ray … Read more

DeepTek’s chest X-ray screening solution, Genki receives Thai FDA approval – ET HealthWorld

DeepTek’s chest X-ray screening solution, Genki receives Thai FDA approval – ET HealthWorld

Pune: DeepTek announces that its revolutionary chest X-ray screening solution, Genki, has received approval from the Thai Food and Drug Administration (FDA). Genki leverages cutting-edge AI technology to classify scans as normal and abnormal along with further analysing over 19 different chest pathologies. By automating the interpretation of chest X-rays it offers immense potential for … Read more

Elon Musk’s Neuralink gets FDA approval for study of brain implants in humans – ET HealthWorld

Elon Musk’s Neuralink gets FDA approval for study of brain implants in humans – ET HealthWorld

Bengaluru: Elon Musk‘s brain-implant company Neuralink on Thursday said it had received a green light from the US Food and Drug Administration (FDA) to kickstart its first-in-human clinical study, a critical milestone after earlier struggles to gain approval. On at least four occasions since 2019, Musk has predicted that his medical device company would begin … Read more

DeepTek.ai’s Augmento receives US FDA clearance – ET HealthWorld

DeepTek.ai’s Augmento receives US FDA clearance – ET HealthWorld

Pune: DeepTek.ai’s AI-powered radiology workflow management solution, Augmento has received 510(k) clearance from the US Food and Drug Administration (FDA) for clinical use. The Indian Radiological and Imaging Association has released a report indicating a critical shortage of radiologists in the country. The ratio of radiologists to population is only one per 100,000 people, significantly … Read more

Philips makes $631 mln provision for recall litigation costs – ET HealthWorld

Philips makes $631 mln provision for recall litigation costs – ET HealthWorld

Amsterdam: Philips, a Dutch health technology company on Monday said it had set aside 575 million euros ($631 million) for possible litigation costs related to its global recall of respiratory machines. Amsterdam-based Philips is grappling with the fallout of a global recall of millions of respirators used to treat sleep apnoea, announced in June 2021 … Read more

Medical watch CardiacSense gets approval from Indian regulatory authority CDSCO – ET HealthWorld

Medical watch CardiacSense gets approval from Indian regulatory authority CDSCO – ET HealthWorld

New Delhi: Homegrown MedTech solutions provider Xplore Health on Thursday announced that it received approval from the Indian Regulatory Authority CDSCO (Central Drug Standard Control Organisation) under the Health Ministry of India for its aspirational medical smartwatch “CardiacSense“. The approval came ahead of its commercial launch in collaboration with Israeli Medtech company CardiacSense Ltd. The … Read more

Lupin Digital Health launches evidence-based holistic heart care programme LYFE, Health News, ET HealthWorld

Lupin Digital Health launches evidence-based holistic heart care programme LYFE, Health News, ET HealthWorld

Mumbai: Lupin Digital Health announced the launch of its digital therapeutics solution, LYFE, an evidence-based holistic heart care programme that significantly reduces the risk of a heart attack and improves vitals and quality of life for cardiac patients. Designed by leading Indian cardiologists, the programme helps patients improve their heart health through doctor-connected online and … Read more

Garmin brings ECG support to its smartwatches, Health News, ET HealthWorld

Garmin brings ECG support to its smartwatches, Health News, ET HealthWorld

New Delhi: Garmin is finally allowing its users to take an electrocardiogram reading using their smartwatches. The company has announced its new ECG app and it is currently available in the US for users who happen to have a Venu 2 Plus smartwatch. The new app allows users to record heart rhythms and check for … Read more