AORN Releases 2021 Guidelines for Perioperative Practice

The Association of periOperative Registered Nurses (AORN) has published the 2021 Guidelines for Perioperative Practice with six revised guidelines.

Masimo Announces iSirona Connectivity Hub

Masimo has announced the global launch of iSirona, a compact, versatile connectivity hub designed to maximize interoperability across the continuum of care.

DJO Acquires Trilliant Surgical

DJO LLC, a global provider of medical technologies to get and keep people moving, has announced the acquisition of Trilliant Surgical, a national provider of foot and ankle orthopedic implants.

DePuy Synthes Receives 510(k) FDA Clearance for VELYS™ Robotic-Assisted Solution Designed for Use with the ATTUNE Total Knee System

The Johnson & Johnson Medical Devices Companies announced that DePuy Synthes has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYS Robotic-Assisted Solution designed for use with the ATTUNE® Total Knee System and its cleared indications for use.

FDA Issues New Policy on Devices for ECMO Therapy During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of certain FDA-cleared or FDA-approved extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to expand device indications or modify designs to increase device availability and facilitate long-term ECMO therapy.

Certain cardiopulmonary bypass devices used to pump blood or oxygenate blood can be used for longer periods of time than currently indicated and may help address urgent public health concerns by expanding the availability of devices to provide ECMO therapy for patients experiencing acute respiratory failure and/or acute cardiopulmonary failure.

This policy reflects FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19.




Submit a Comment

Your email address will not be published. Required fields are marked *