Regulatory issues across different countries are one of the major restraining factors for the growth of the global ingestible sensors market. Ingestible sensors are tiny ingestible electronic devices that can be swallowed and then pass through the digestive system, providing physiological data from inside the body. However, stringent regulations involving products related to medical devices and health have made approval processes very lengthy and complex for ingestible sensors. Various countries have their own regulatory requirements and approval processes to ensure safety and efficacy of medical devices before they can be commercialized. For example, in the U.S., the Food and Drug Administration (FDA) classifies ingestible sensors as medical devices and regulates them under different categories based on the associated risks. Getting approval involve extensive clinical trials and testing which can delay market launch by several years. Similarly, the European Medical Agency (EMA) also has strict norms where new medical devices need to comply with EU Medical Device Regulation to gain CE marking before they can be sold in European countries. Complying with varied regulations across different markets lengthens the time taken to commercially release these sensors.
Market Opportunities – Progress in Capsule Endoscopy
Capsule endoscopy involves patients swallowing a small camera capsule that takes thousands of pictures of the digestive tract as it travels through. This non-invasive procedure allows physicians to detect diseases like celiac disease, Crohn's disease, and small intestinal cancers more effectively compared to other usual diagnostic tests. The technology behind capsule cameras has advanced significantly in recent years, with improvements in image resolution, larger data storage capacity and options for control over the camera. Newer capsule endoscopes feature magnets that allow doctors to control the movement of the capsule using an external device. This provides the ability to stop, start or change the direction of the capsule when required. Some capsules can also release medications at targeted locations or take biopsies using detachable multipurpose tools. With continuing technological developments, future capsules may be embedded with sensors to detect biomarkers in real-time and transmit the results. This would enable continuous monitoring of diseases and timely interventions. The decreasing size of electronic components has made it possible to pack more advanced capabilities into tiny ingestible sensors.
Ingestible Sensors Market Report Snapshots
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