Devices and Gadgets Archives | Future Medicine India

Devices and Gadgets

US FDA issues EUA to decontamination system for N95 masks

The FDA granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 low-temperature sterilization systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide.

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Cerus’ flow diverter aneurism device receives CE mark

Cerus Endovascular Ltd announced that it has received CE Mark approval for its Neqstent Coil Assisted Flow Diverter device, to treat intracranial aneurysms.

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510(k) clearance to TDi’s spine surgery platform

Tissue Differentiation Intelligence, LLC (TDi) has received 510(k) clearance for the company’s SonoVision ultrasound platform designed for intraoperative access to the spine.

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X100 full-field blood smear analyser receives CE mark

Scopio Labs has received CE mark certification for its X100 Full Field Peripheral Blood Smear (Full Field PBS) all-digital morphology analysis platform.

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Abbott receives CE mark for tricuspid valve repair system

Abbott said its TriClip Transcatheter Tricuspid Valve Repair System has received CE mark as a non-surgical treatment for people with tricuspid regurgitation (TR).

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EUA for blood purifier for COVID-19 patients

The US FDA issued an emergency use authorisation for Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices, a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

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FDA nod for total wrist replacement device

The US FDA has approved KinematX, a new total wrist replacement device for people with arthritis.

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