There was quite a bit of buzz on Friday, April 1, about Embecta. The newly public diabetes company completed its separation from BD and began trading on the Nasdaq. MD+DI Managing Editor Omar Ford hosted the new company's CEO, Devdatt Kurdikar, on Let's Talk Medtech to discuss the spinout and what will give Embecta an edge in the diabetes tech market.
Medtronic said it is recalling some of the In.Pact Admiral and In.Pact AV Paclitaxel-coated Percutaneous Transluminal Angioplasty balloon catheters because of manufacturing issues. The company said that some pouch damage was discovered during a routine inspection. Upon investigation, a change implemented to one manufacturing line was determined to be the cause. All batches manufactured on this line after that change are being retrieved. The problem on that line was fixed. Additionally, production on all lines was paused until a follow-up packaging inspection was completed. Medtronic said no further errors were discovered.
Citing shortages of critical components in combination with other supply chain issues, including freight carrier delays, the Irvine, CA-based medtech company said it now expects its product revenue for the first quarter to range from $285 million to $315 million. That is below analysts' consensus forecast of $330.1 million.
And in case you missed our last Medtech in a Minute report...
Details surrounding the proposed fifth iteration of the medical device user fee amendments (MUDFA V) have been made public. Under the proposed measure, FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met. FDA said this funding would provide critical resources to its medical device review program. The agency said it will hold a virtual public meeting April 19 to obtain comments on the medical device user fee amendments.
InnoSIGN has completed its spinout from Philips with the help of an $8 million financing. The new company was formed around the OncoSIGNal pathway activity profiling technology. The OncoSIGNal technology is mRNA-based tests that measure the activity of signal transduction pathways in cancer and immune cells to predict how patients will respond to targeted drugs.