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FDA revokes emergency nods for KN95 respirators and disinfecting hardware as mask supplies rebound
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Marks: Yankees breakthrough Covid cases not shocking
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POLICY
An unconventional new model makes industry meetups a key part of medical
device regulation. by Timothy Gower
Biopsies are still mostly read under a microscope by a human pathologist. The diagnostic process can be a painstaking endeavor and often renders an up-or-down opinion: cancer or no cancer, for example. Digitizing this work would not only speed up processing but, coupled with artificial intelligence, might give more accurate information a 90% chance a tissue specimen is malignant and the patient will respond to a therapy, for example that could affect treatment considerations.
But this frontier of digital pathology calls for new tools scanners, viewers and software. And a lack of regulatory standards for these components has slowed their development and wider adoption. The same story is echoed across many new areas where device innovation moves quickly but expertise is limited to a small circle of specialists.
A year into pandemic, federal officials design new mask guidelines to better protect more workers
A group of prominent scientists had written to the White House in February, saying a broader swath of U.S. workers need more protection from the airborne virus.
Written By:
Christina Jewett / Kaiser Health News | 11:46 am, Apr. 19, 2021 ×
A mask with 3M and N95 labeling. Unsplash
Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from COVID-19.
The changes come as U.S. mask-makers say the demand from hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing concerns about scarce supplies, saying limits on which workers should get N95s must stay in place.
A year into pandemic, federal officials design new mask guidelines to better protect more workers
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