Today the FDA will officially exempt individual genetic risk tests from 501(k) premarket approval with the condition that the company offering the test should have a one-time premarket review of its testing apparatus and at least one test.
A study conducted in ten hospitals found that NIPT (Non-Invasive Prenatal Screening Test), was safer, more accurate and more effective in detecting chromosomal abnormalities in unborns, compared to conventional marker tests and ultrasound studies.
In November, FDA’s device center will select which app is welcomed into the program, and the selected will have amplified interactions with FDA during the progress of their products. FDA will grant the advanced device nomination to products that meet the permitted criteria without requiring a separate application.
Determined to cap the profits of private hospitals in Delhi and the NCR region, Delhi health minister Satyendra Jain has announced an array of new rules. He clearly stated that hospitals will be mandated to sell essential medicines at MRP and can no longer charge a markup.
It is always advised to drink water. But recent studies have shown that there may be a limit as to how much. Overconsumption of water causes a decrease in sodium levels and fluid accumulates excessively in the brain, which leads to its swelling. This life-threatening condition, termed as Hyponatremia, is more commonly prevalent among the elderly.
The IVD sector in the country is chiefly characterized by 70 percent laboratories offering pathology services and 30 percent entities doling out radiology and imaging services. Though domestic players are flexing their muscles and are gearing to provide new-age diagnostic services with path-breaking innovations and strategic investments, multinational companies continue to hold sway over 60% of the domestic IVD market which is expected to grow by leaps and bounds in coming times.
Though the US stands first in the race in terms of sales and growth, it is highly believed that China would reach the peak in the pharma market by 2022. At present, since there has been a decrease in public health funding, there has been a slight fall in pharmerging countries like Brazil, Russia, India and China (BRIC). But it is believed that the condition of these pharmerging countries will improve in the next five years [1].
A research team at the University of Michigan were developing a pill which shows the presence of tumors when exposed to infrared light, and their concept worked well in mice.
A simple key strategy discovered by the research team at the London School of Tropical Medicine, will turn out to be a major breakthrough in the field of Malarial prevention. Malaria-infected children were more prone to malarial mosquitoes by producing distinctive skin smells, compared to uninfected children.
On April 20, 2018, Qiagen announced the FDA approval of the novel test named PartoSureTM, used for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.
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