BETA
Italian manufacturer of REMS ultrasound systems for bone-density assessment, fracture-risk evaluation and selected diagnostic imaging applications.
Echolight S.p.A. is a medical-device manufacturer headquartered in Lecce, Puglia, Italy, founded in 2010 as a spin-off of Italy’s National Research Council. Its U.S. operation is Echolight Medical Corp.; current manufacturer contact information lists a Houston office.
The company develops Radiofrequency Echographic Multi Spectrometry (REMS). Its EchoS family combines ultrasound hardware with EchoStudio software to assess bone mineral density at the lumbar spine and femoral neck. Optional software and hardware modules address fracture-risk assessment, body composition and other ultrasound imaging applications within their labeled scope.
Current U.S. marketing lists EchoStation, EchoS Plus, EchoHybrid Plus and OsteoS BH. Individual model mapping and each FDA decision’s scope are distinguished below. Upright Medical Solutions separately advertises Echolight REMS technology.
Three relevant 510(k) decisions were found: K180516 for EchoS, K202514 for the EchoS family and K212851 for optional EchoSK/EchoSGyn modules. These are FDA clearances rather than PMA approvals. The family snapshot retains successive decisions without treating each as a separate product. [11][12][13]
K202514 covers bone sonometry, an optional five-year fracture-risk tool and a body-composition module. Body composition is intended for generally healthy adults and is not for diagnosis of disease. K212851 adds labeled musculoskeletal and gynecological/obstetric imaging applications; manufacturer marketing does not expand these indications. [8][9][10]
The U.S. website lists OsteoS BH alongside the EchoS configurations, but its precise FDA model mapping was not established. A GE MRI “ECHOS” name match in recall searches is unrelated and excluded. [5]
Published FDA searches under the company and selected product names found no relevant original PMA approvals, De Novo grants or recall events. Unrelated name matches are excluded. [17][18][19][20]
Latest recorded source review: 2026-10-27.
Documented commercial product families.
Ultrasound/RF hardware with EchoStudio software. Current marketing names EchoStation, EchoS Plus and EchoHybrid Plus; optional Fragility Score, Body Composition, EchoSK and EchoSGyn modules have distinct indications. [5][8][9][10][11][12][13][22]
FDA-clearedCommercially marketed in Italy and the United States; model, module and jurisdiction-specific labeling applies.
Compact ultrasound system marketed for assessment of lumbar vertebrae and femoral neck bone health. [5][23]
Manufacturer-marketed; model-specific FDA linkage not establishedCurrently listed on the manufacturer’s U.S. product website.
The official careers page lists Web Applications Developer, Test and Production Engineer and Clinical Scientist roles in Lecce. These are advertised roles rather than an employee-growth rate. The U.S. subsidiary and marketed portfolio document international commercial activity without establishing availability in every market. [2][7]
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Upright Medical Solutions (distributor-reported) [21] | U.S. provider-facing offering; product-specific territory and active contract not independently confirmed | Echolight REMS bone-health assessment technology; exact model scope not specified |
Sources checked October 26, 2026.
K202514 covers the EchoS family and specified optional tools. [11]
Accessed 10/29/2026
Last substantive review: 10/27/2026