Another recall for Covidien's Nellcor ventilator business
January 6, 2015 by Mark Hollmer
A ventilator made by Covidien’s Nellcor arm has attracted yet another Class I recall label from the FDA – its most serious designation. At issue this time: a part failure could lead to a burning odor and has already jeopardized patient safety.
The Nellcor Puritan Bennett 980 Ventilator System is attracting all the scrutiny. According to the FDA, part of a circuit board used in the product may have cracks due to manufacturing issues. If this happens, the ventilator’s display screen dims, and the system starts producing a burning smell. Read more
MiMedx reveals subpoena, lawsuit against rival, beefs with FDA
January 6, 2015 by Mark Hollmer
MiMedx said it received a subpoena over sales and marketing of its regenerative biomaterial products and bioimplants made from human amniotic membrane. The Georgia company also disclosed a lawsuit against a rival it accuses of unfair business practices and a beef with the FDA over proposed new regulations.
First, the civil subpoena: MiMedx said it received the document from the Office of Inspector General of the U.S. Health & Human Services Dept. as part of a probe into its sales and marketing practices. Read more
Quanta wins CE Mark for portable dialysis device
January 6, 2015 by Mark Hollmer
Quanta Fluid Solutions said it nailed additional funding that boosted its recent investment round to $44 million. The money is well timed, considering the U.K. outfit recently gained a CE Mark for its portable, cartridge-based hemodialysis system.
Plans call for rolling out Quanta’s SC+ product this year. CEO John Milad noted in prepared remarks that the regulatory win is a big milestone for the company. Quanta launched in 2008, spun out from engineering company IMI, and is backed by investors including Wellington Partners and NBGI Ventures. Read more
Cohera Medical wins approvable letter from FDA for TissuGlu surgical sealant
January 6, 2015 by Brad Perriello
Cohera Medical today said it received an “approvable letter” from the FDA for its TissuGlu surgical sealant, noting that it expects to win pre-market approval “within a few weeks.”
TissuGlu is a polyurethane-based sealant designed for use in large-flap surgical procedures including abdominoplasty. It’s been on the market in Europe since September 2011 for the same indication. Read more
FDA lifts import ban on Hospira infusion pumps
January 8, 2015 by Brad Perriello
Hospira said today that the FDA lifted an import ban it instituted back in November 2012 on infusion pumps made at Hospira’s Costa Rica plant.
“Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates, and will resume the importation of these devices into the United States immediately,” the Lake Forest, Ill.-based company said. Read more