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).

Proposed Standard Will Provide Cleaning Agent Formula for Medical Devices

ASTM International

ASTM International’s committee on medical and surgical materials and devices (F04) is developing a proposed standard that will provide a cleaning agent formula to clean dried blood from stainless steel medical devices.

According to ASTM International member Ralph Basile, the formula described in the new standard will be tested against the relevant tests in D8179, ASTM’s guide on medical device detergents (D8179).

“This will help to provide practical application of D8179, as well as provide a baseline of cleaning agent formulation for this purpose that manufacturers of cleaning agents can compare their formulation to,” said Basile, vice president, Healthmark Industries.

Basile notes that manufacturers of cleaning agents, independent testing laboratories, other standards organizations, regulators, medical device manufacturers, and healthcare professionals responsible for cleaning clinically-used medical devices will all find the proposed standard (WK70410) useful.

All interested parties are invited to join in the proposed standard’s ongoing development, which will include an interlaboratory study. Participants include:

  • Cleaning agent manufacturers,
  • Manufacturers of raw materials used in cleaning agents
  • Testing laboratories,
  • Medical device manufacturers,
  • Cleaning challenge device manufacturers, and
  • Regulators.

The committee encourages participation from others representing these stakeholders along with representatives from other stakeholder groups.

ASTM welcomes participation in the development of its standards. Become a member at



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