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FDA regulations
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.
Health IT Now asks HHS to review, clarify ONC role
Group contends that the HIT agency may have overstepped original authority provided under the HITECH Act, says HITN’s Robert Horne.
Next 12 months will be crucial in finding uses for blockchain
Cooperation needed as industry moves to prototypes and early deployments, says Steven Posnack.
FDA clears non-prescription Type 2 diabetes digital therapeutic
WellDoc hopes agency’s approval will offer more options for adoption, expanded access.
FDA finds St. Jude Medical cardiac devices can be hacked
Company acknowledges security risk, offers patch to harden security of RF-based system.
FDA not planning to develop guidance on CDS in 2017
Lack of rules is having a chilling effect on vendor development, says Bradley Merrill Thompson.
See more FDA regulations
