Spectranetics
This article was originally published in The Gray Sheet
Executive Summary
Submits a premarket approval application on June 8 to FDA for peripheral vascular applications of its CVX-300 excimer laser system, Robert DePasqua, company president and CEO announced at the June 15-17 Piper Jaffray Conference in Minneapolis. The firm has been marketing the system for treatment of coronary artery disease since it received agency approval in February ("The Gray Sheet" March 1, p. 9). The firm also expects summer approval of a PMA supplement for its second generation laser system, and a PMA supplement for a third-generation system, the Vitess rapid- exchange laser catheter, will be submitted to FDA in the fall.
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.