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Abbott Laboratories Inc.

Latest From Abbott Laboratories Inc.

Siemens Healthineers Floats On Frankfurt Stock Exchange

Siemens Healthineers is a publicly listed company now that its shares debuted on the Frankfurt Stock Exchange on March 16.

Companies In Vitro Diagnostics

Abbott, Merck Like FDA's Plan To Amass More Summary Adverse Event Reports, But P&G Says There's A Better Way

While mammoth manufacturers Abbott Laboratories and Merck & Co. – along with device industry advocacy groups – are supporting the US agency's proposed Voluntary Malfunction Summary Reporting Program, Procter & Gamble Co. is urging FDA to think twice. In comments to the agency, P&G's principal scientist says the program, which will allow firms to submit Medical Device Reports to FDA quarterly in a bundled format for a wide array of products, should be scrapped and replaced with an 11-year-old congressional mandate that aimed to boost summary reports.

FDA Safety

FDA Pathway Options Are Growing For Diagnostics, FDA's Gottlieb Tells Commercial Labs

While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.

Legislation Regulation

US CMS Coverage Office Reorganizes In Effort To Improve Efficiency

The office that oversees Medicare coverage decisions and policies has restructured in an effort to improve predictability and efficiency in evaluating new technologies. Medtech industry leaders say more reforms are needed.

Reimbursement Market Access
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