Approvals

AMDT’s FixSix System Cleared by FDA

The FDA granted 510(k) clearance to AMDT’s FixSix software and instrumentation, used to analyze and correct limb deformities.

Intended for use with the Smith and & Nephew Taylor spatial frame, the system reduces the time and effort needed for inputting measurements.

After inputting the measurement data, the system generates a prescription defining incremental adjustments to be made to the spatial frame’s strut that will correct the deformity.

FDA Clears PhysIQ’s Atrial Fibrillation Analytic

The FDA granted 510(k) clearance for PhysIQ’s atrial fibrillation analytic designed to generate clinical insight from wearable biosensors.

The clinical insight the analytic generates can help clinicians reduce re-hospitalization rates and move towards personalized precision medicine for atrial fibrillation.

The analytic is intended to support both health systems and payers in addition to pharmaceutical and medical device companies that use wearable biosensors in their clinical trials.

Medtronic’s Sheathed Bipolar Sealer Granted 510(k) Clearance

The FDA handed 510(k) clearance to Minneapolis devicemaker Medtronic’s Aquamantys sheathed bipolar sealer, a device used for hemostatic sealing during spinal cases.

The device enables surgeons to stop bleeding from cut muscle and epidural veins using a combination of radiofrequency energy and saline in order to reduce blood loss and increase visualization during spinal procedures.

The device’s ability to reduce blood loss has been linked to faster surgery times and reduced rates of blood transfusions.