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Getinge, Cook Medical Reach iCast Distribution Agreement

Getinge and Cook Medical have announced an exclusive sales and distribution agreement for the iCast covered stent system.

Endorail Earns FDA 510(k) clearance: Next-generation magnetic balloon technology optimizes colonoscopy procedural outcomes

Endostart, a pioneering medical device company specializing in gastrointestinal endoscopy solutions, HAS announces a major breakthrough with the FDA 510(k) clearance of its flagship product, Endorail. This achievement represents a significant step forward in advancing...

Survey: Nurse Shortage a Leading Threat to Industry

In honor of Certified Nurses Day, health tech company Carta Healthcare®, whose mission is to harness the value of clinical data, today released the results of a survey about the pain points that health care professionals are currently experiencing. The survey also...

Modular Lab Furniture Systems Meet Needs

UniLine Furniture offerings from HEMCO Corp. include base cabinets, wall cabinets, countertops, sinks, fixtures, base tables, mobile work stations, specialty storage cabinets and peg boards.

Some Filtering Facepiece Respirators Concern FDA

The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) manufactured in China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19. These concerns are based on test results from the National Institute for Occupational Safety and Health (NIOSH) showing that some of these respirators do not meet their labeled performance standard.

This Letter to Health Care Providers describes:

  • Changes to the FDA’s Emergency Use Authorization for respirators manufactured in China and removal of some of these respirators from the Appendix listing authorized respirators.
  • Considerations for health care organizations when using or purchasing respirators.
  • Actions the FDA has taken to help ensure the quality of respirators.
  • Instructions for reporting problems with respirators to the FDA.

Read the full Letter to Health Care Providers at FDA.gov »

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