The Womb Music is very safe and is designed to be used for home use. It has been both FDA and CE certified. FDA Registration Number 3011572016However, it is not a medical device to be used instead of normal medical checkups by a doctor."Ultrasound has been routinely used in obstetrics for more than 30 years. There is no scientific evidence of any harmful effects to the baby from the use of ultrasound during pregnancy. It's considered a very safe procedure because it doesn't involve potentially harmful radiation, so ultrasound is safe for both mother and baby." as quoted by the Mayo Clinic.Testing is continuously done by multiple government agencies including the FDA which have indicated this type of monitoring has no adverse effect on the baby. While the Food and Drug Administration (FDA) has cleared this monitor for "continuous use" we recommend moderation with limited use in short intervals of 10 minutes or less, infrequently and primarily after the first trimester. If you are ever concerned we recommend that you seek the counsel of your doctor.The Womb Music also does not use radiation of any kind, only sound waves are used, to monitor the baby's movements or heartbeat.