FDA clears 1st cuffless BP monitors

Anicka Slachta | | Cardiovascular Business | Heart Health

Biomedical tech company Biobeat has received 510K clearance for its noninvasive, cuffless BP-monitoring systems.

The Tel-Aviv, Israel, company was granted FDA clearance for two distinct products—a smartwatch and a wearable patch. The former is worn on the wrist and the latter can be fixed anywhere on the upper torso, but both measure blood pressure, oxygenation and heart rate in hospitals, clinics and at home.

The products connect to a cloud-based system either through a smartphone or a dedicated gateway.

“This is the first cuffless blood pressure solution to be cleared by the FDA—no more need for an inflating cuff,” Arik Ben Ishay, founder and CEO of Biobeat, said in a statement. “This clearance opens tremendous opportunities for remote monitoring of vital signs of patients and we are excited that we can now also offer this in the U.S. market.”

Biobeat’s products have already been CE marked and approved as medical devices in both Europe and Israel.

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Anicka Slachta

After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.

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