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.


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.


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.


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).


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.


FDA nod for total wrist replacement device

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