NEW

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.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

Camber Spine Expands Patent Portfolio with SPIRA Lateral 3.0

Camber Spine has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for its SPIRA Lateral 3.0 interbody fusion implant.

UVDI-360 Room Sanitizer Inactivates SARS-CoV-2 at 12 Feet Distance in 5 Minutes

UltraViolet Devices Inc. (UVDI) has announced that its UVDI-360 Room Sanitizer achieved greater than 99.99%, or 4log10, inactivation of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) in 5 minutes at a distance of 12 feet (3.65 meters).

Getinge Announces Voluntary Recall

Getinge is announcing a medical device correction of the 46-Series Washer Disinfectors in the U.S due to a missing water intake for Deionized water (DiW). Getinge has reported to relevant authorities according to applicable regulations and the cost for the recall is not material.

Getinge has identified during installation that 11 units have been delivered to end users without water intake for Deionized water (DiW). The product non-conformity presents a potential delay in installation of the device at the end user facility and/or potential procedure delay in the customer’s workflow. The units affected by this recall were not used on a patient and there have been no adverse events reported resulting in serious illness or injuries caused by the Getinge 46-Series Washer Disinfector issue. All affected customers have received communication from Getinge.

This information is released in order to inform users of mentioned Getinge products, according to standard procedures recommended by regulatory authorities.

Previous

Next

Submit a Comment

Your email address will not be published.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

X