The US Food and Drug Administration (FDA) has granted 510(k) clearance for a handheld device (Pronto-7; Masimo) for noninvasive hemoglobin spot-check testing, along with saturation of peripheral oxygen, pulse rate, and perfusion index, in virtually any environment.

The needleless, palm-sized instrument, with dimensions of 5.1″ × 2.8″ × 1″ (13 × 7.2 × 2.5 cm) and weight of 10.5 oz (296 g), measures hemoglobin levels in less than 1 minute. Embedded 802.11 b/g and Bluetooth communication capabilities allow test results to be quickly printed and emailed. According to a company news release, future upgrades will also allow wireless transmission of data to electronic health record systems.

“Noninvasive hemoglobin spot-check testing…[reduces] the time to take blood, send it to the lab, and call patients back with their results,” noted Aditya Chopra, MD, a private practice internist in Annapolis, Maryland, in a company news release.

The device may also contribute to improvements in quality of care for patients with anemia, which affects 1.6 billion people worldwide and causes 1 million deaths each year.

“Noninvasive hemoglobin testing at the point-of-care offers a giant leap forward in our ability to tackle the global burden of anemia. Although it is a common blood disorder, it is grossly under-tested and under-diagnosed. And, if left untreated, anemia has a variety of serious health consequences and complications,” said Aryeh Shander, MD, president-elect of the Society for the Advancement of Blood Management, in a company news release. “The beauty of immediate, noninvasive hemoglobin testing is that it will allow more patients to be assessed, so their physician can determine additional test options and initiate potentially lifesaving treatment.”

Dr. Shander is also the executive medical director of the Institute for Patient Blood Management & Bloodless Medicine and Surgery at Englewood Hospital and Medical Center in Englewood, New Jersey.

The handheld device previously was granted CE Marking by the European Commission, allowing its use in the European Union.