In the industry's words
This article was originally published in RAJ Devices
Executive Summary
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the potential changes threaten its position as global leader in the supply of these products. Mark Leahey, president and CEO of the Medical Device Manufacturers Association, warns against any move that might lead to a major weakening of medtech innovation
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.