Biosense has been offering a urinalysis facility for diabetics and other patients on the iPhone. However, the Food & Drug Administration (FDA) of the United States has refused to give it a stamp of approval. In fact, it has led an inquiry into the matter saying that the electronic urinalysis device must pass its standards via a through testing process.
Testing for the presence of glucose, proteins and ketones in the urine is normal practice among patients of diabetes and kidney disease. Several iPhones have this facility and it works through a series of sensitive strips being dipped in the urine and then tested by electronic methods for immediate results. According to Bloomberg, while it is very convenient for users, the technology has not been approved by the FDA. The reason behind this is that the components for this device are manufactured by Siemens and Bayer.
While as far as visual decoding is concerned it seems alright, when it comes to automatic analysis these strips manufactured by the two companies are lacking in authenticity and credibility. Going by the name of uChek, this device by Biosense was bypassed by the FDA and finally a letter of warning was sent by the authority. According to the FDA it wants more stringent standards for such test results in the medical locus of control. In matters having to do with life and death, accuracy was the key virtue. It plans to extend these rules to cover heart health equipment, ultrasound machines and many other devices having to do with disease prevention and the healing arts.
It remains a bone of contention that any malfunction of a machine may put at risk a patient’s life. Better to be safe than sorry. That is the major purpose behind the FDA’s stance against Biosense. The fact of the matter is that even the slightest skewing in test results could spell the difference between health and disease for a person suffering from an ailment. Inaccuracy and faulty functioning are risks that simply cannot be taken.
Meanwhile, the administration at Biosense has made a statement regarding this conflict of interest. It plans on working in tandem with the FDA to chalk out a plan that would be suitable to both parties.The letter from the FDA did have its effect. Besides airing concern over the correction of technology, the FDA has also asked Biosense to respond within a month’s time regarding the badge of approval it must obtain from the US agency that regulates everything from patent medicine to health supplements.