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FDA regulations
FDA clears a new robotic system for use in surgery
Platform enables surgeons to employ computer and software to move surgical instruments.
FDA clears glucose monitoring system that doesn't require fingersticks
Abbott Diabetes Care device uses a small sensor wire and mobile reader to measure blood sugar levels.
FDA picks 9 vendors for digital health software precertification pilot
Apple, Fitbit and Samsung are among the companies participating in the agency’s new program.
FDA seeks entrepreneurs-in-residence for pilot
Agency will select 6 digital health fellows to develop and test the software precertification program.
FDA lays out digital health plan to foster innovation
A key component of agency’s regulatory redesign efforts is a new software precertification pilot program for developers.
Senate votes to install Gottlieb as FDA commissioner
His confirmation comes at a critical time as regulatory agency looks to bolster its digital health initiatives.
FDA to create centralized digital health unit
New office will hire staff with expertise in AI, cloud computing and cybersecurity, says Bakul Patel.
New tech could change how pathologists view tissue samples
Clinicians now can read tissue slides digitally rather than using a conventional microscope.
FDA approves 10 consumer genetic risk tests
23andMe exams get the OK; agency may reduce regs for other genetic testing firms.
FDA pick Scott Gottlieb says opioid epidemic is top crisis
The agency will use a number of approaches to reverse massive overdose cases.
See more FDA regulations
