Signostics Medical, maker of more affordable, compact and portable ultrasound devices, announced today that it has gotten the stamp of approval from the Food and Drug Administration. Based in Palo Alto, Calif., the company says the price and convenience of its palm-sized product could disrupt the current ultrasound market as soon as it’s released.

Weighing only half a pound, the device appears to be particularly well-suited to active medical environments like emergency rooms, pediatric facilities, clinics in rural or developing regions and sports medicine practices. Physicians can actually carry the devices in their pockets, or wear them around their necks like a stethoscope, Signostics says. Despite its relative simplicity, the machine still provides clear images during bladder, abdnominal and intestinal screenings. It can also be applied for obstetric purposes, to view babies and their positions within the uterus.

Providing quality maternal health care is one of the most challenging areas of medicine in developing countries, mostly because clinics lack durable, practical equipment needed for adequate prenatal exams. Signostics’ product could potentially change that, further growing the already $3 billion annual ultrasound market.

The device will retail for $4,000 in the U.S. With regular ultrasound machines costing upwards of $150,000, the price break could radically increase the number of health care settings offering potentially life saving ultrasound services. The lower price is made possible by tiny chips from Analog Devices that allow for high image clarity. Signostics has yet to release a timeline for commercialization.

So far, the company has funded product development with capital from angel investors and Playford Capital, and grants from the Australian government. It is about to close a new $4 million round of financing, bringing its total raised to $12 million.