CryoLife BioGlue
This article was originally published in The Gray Sheet
Executive Summary
Investigational device exemption supplement is submitted to expand studies of the surgical adhesive to include use in vascular and certain cardiac repairs in addition to the commercially approved use as an adjunct in acute thoracic aortic dissections, cited in the original June 1998 IDE. A December FDA Humanitarian Device Exemption approval covers the latter indication, and shipments commenced Jan. 3 (1"The Gray Sheet" Dec. 20, p. 24)
You may also be interested in...
CryoLife BioGlue
Surgical adhesive is granted a humanitarian device exemption as an adjunct with sutures or staples in aortic dissection procedures. The HDE allows use of the adhesive to "facilitate surgical repair of acute thoracic aortic dissections by obliterating the false channels and strengthening the friable diseased aortic tissue for suture placement"
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.