FDA Participates in New 'Collaborative Communities' to Address Emerging Challenges in Medical Devices itnonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from itnonline.com Daily Mail and Mail on Sunday newspapers.
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.