STAT1d
Texas judge strikes down FDA’s plan to regulate lab-developed tests
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...
Judge foils FDA plan to regulate lab-developed tests
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
GlobalData on MSN2d
Locke Bio and imaware join forces to integrate lab testing into telehealth
Locke Bio has announced a partnership with lab-testing provider imaware to incorporate diagnostic testing into its telehealth ...
FDA Lacks Authority to Regulate Laboratory Tests, Judge Rules
A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...
MedTech Dive2d
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
The News-Press23d
Fort Myers-based NeoGenomics expands cancer testing reach with acquisition
Pathline offers laboratory testing services for a wide range of ... testing for the patients that we serve under the NeoGenomics banner moving forward.” NeoGenomics expects the deal to ...