Tecnoideal America has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its haemoconcentrators.
These devices are designed for adult patients to manage fluid levels during or after cardiopulmonary bypass surgery.
This development was announced by Amarex Clinical Research, an NSF company and full-service contract research organisation (CRO) whose client is Tecnoideal America.
The regulatory department at Amarex worked in collaboration with Tecnoideal America to conduct the necessary performance and substantial equivalence tests.
The data from these tests demonstrated that the device is substantially equivalent to its predicate device, leading to the successful clearance.
Amarex global regulatory and clinical affairs head Dr Ahmad Bayat said: “We worked closely with Tecnoideal to initiate this development by leveraging knowledge learned from past FDA applications and adhering to current FDA recommendations.
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“As a result, the 510(k) studies and application were finished within five months, leading to rapid 510(k) clearance. This accomplishment demonstrates Amarex’s capacity for successful collaboration and highlights our strength in product development.”
Tecnoideal’s parent company Medica president Luciano Fecondini said: “We are excited to achieve FDA approval for our haemoconcentrators. This milestone marks the first approval of blood purification devices, and we have already begun the 510(k) application process for other devices in our pipeline.”
Tecnoideal America provides assembly equipment for medical device manufacturers, including customised automated assembly lines.
It also offers pre-sale assistance, after-sales support, preventive maintenance, and spare parts.
Amarex Clinical Research is engaged in designing and conducting clinical research projects in many therapeutic indications.
