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626 Acquires Medical Imaging Solutions

CEO Hints at Additional Acquisitions 626 Holdings LLC recently announced the addition of Medical Imaging Solutions (MIS). “MIS could not be a better fit. The addition of MIS helps both our customers and our employees win on many different levels including the...

FDA Clears Symbia Pro.specta SPECT/CT Scanner

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Symbia Pro.specta, a single-photon emission computed tomography/computed tomography (SPECT/CT) system with advanced CT and SPECT imaging technologies. Capabilities include a...

KA Imaging Plans New Mobile X-Ray System

“Through the Ontario Together Fund, our government is making strategic investments in innovative homegrown businesses with the ideas and solutions to help us support Ontario’s vibrant innovation and medtech ecosystem,” said Vic Fedeli, minister of economic development, job creation and tra

ECRI Opens New Global Headquarters

“The new building symbolizes the transformation that ECRI has been undergoing over the past few years,” says Marcus Schabacker, MD, Ph.D., president and CEO of ECRI.

FDA Issues Guidance on Approved Premarket Approval or Humanitarian Device Exemption Submissions

On May 21, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance to help foster continued availability of medical devices during the COVID-19 public health emergency.

Per the guidance, during the COVID-19 public health emergency:

  • The FDA does not intend to object to limited modifications to the design and manufacturing of devices approved through either a PMA or HDE without prior submission of a PMA or HDE supplement or 30-day notice for the duration of the public health emergency.
  • The policy applies to limited modifications to approved HDEs or PMAs that would trigger the requirement that a manufacturer submit a PMA or HDE supplement or 30-day notice to the FDA . Some examples of these limited modifications may include immediate changes adjusting manufacturing processes to allow for social distancing, adapting manufacturing or design due to supply chain disruption, or moving device production to a region that is less impacted by COVID-19.

READ THE GUIDANCE »

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