The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are medtech stories we missed this week but were still worth mentioning.
1. FDA clears Medela’s neonatal enteral feeding device
Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes, according to a March 9 press release. The syringes can help deliver accurate doses and reduce misconnection risks. The new syringes add to Medela’s NICU-specific enteral feeding system products that includes syringes, syringe pumps, warmers, feeding tubes and extension sets. The ENFit Low Dose Tip Syringe was also created to improve oral medication accuracy for small volume delivery in neonatal intensive care units.
2. PAVmed closes additional financing
PAVmed announced the closing of $1 million in additional financing in a March 9 press release. The gross proceeds of PAVmed’s private placement totaled $2.5 million after the closing. The private placement had shares from Series A Convertible Preferred Stock and Series A Warrants. The closing was first announcing in February.
3. InVivo Therapeutics enrolls 12th patient into Inspire study
InVivo Therapeutics announced that a new patient has enrolled in its study of probable benefit of the neuro-spinal scaffold for safety and neurologic recovery in subjects with complete thoracic AIS, according to a March 9 press release. The study, called Inspire for short, is being performed at the Keck Hospital of the University of Southern California. The study’s main researcher, Patrick Hsleh, was able to implant the neuro-spinal scaffold about 82 hours after the injury occurred.