FDA regulations

FDA seeks entrepreneurs-in-residence for pilot

Agency will select 6 digital health fellows to develop and test the software precertification program.

Medical devices Greg Slabodkin September 11

Medical devices Greg Slabodkin September 11
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.

FDA regulations Greg Slabodkin July 28

FDA regulations Greg Slabodkin July 28
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 regulations Greg Slabodkin May 11

FDA regulations Greg Slabodkin May 11
FDA to create centralized digital health unit

New office will hire staff with expertise in AI, cloud computing and cybersecurity, says Bakul Patel.

FDA regulations Greg Slabodkin May 8

FDA regulations Greg Slabodkin May 8
New tech could change how pathologists view tissue samples

Clinicians now can read tissue slides digitally rather than using a conventional microscope.

FDA regulations Joseph Goedert April 20

FDA regulations Joseph Goedert April 20
FDA approves 10 consumer genetic risk tests

23andMe exams get the OK; agency may reduce regs for other genetic testing firms.

Genome sequencing Joseph Goedert April 7

Genome sequencing Joseph Goedert April 7
FDA pick Scott Gottlieb says opioid epidemic is top crisis

The agency will use a number of approaches to reverse massive overdose cases.

FDA regulations Bloomberg News April 6

FDA regulations Bloomberg News April 6
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.

HITECH Act Greg Slabodkin March 15

HITECH Act Greg Slabodkin March 15
Next 12 months will be crucial in finding uses for blockchain

Cooperation needed as industry moves to prototypes and early deployments, says Steven Posnack.

Data and information management Fred Bazzoli January 30

Data and information management Fred Bazzoli January 30
FDA clears non-prescription Type 2 diabetes digital therapeutic

WellDoc hopes agency’s approval will offer more options for adoption, expanded access.

FDA regulations Greg Slabodkin January 26

FDA regulations Greg Slabodkin January 26

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