Stryker launches Mako robotic hip replacement
March 25, 2015 by Brad Perriello
Stryker today said it’s launching a total hip replacement tool for its Mako robot-assisted surgery platform.
Stryker said its Mahwah, N.J.-based orthopedics division won 510(k) clearance from the FDA for the Mako hip system, which is designed to be compatible with all of Stryker’s hip implants. Read more
UPDATE: Abiomed soars to new all-time high on FDA nod
March 24, 2015 by Brad Perriello
News that Abiomed yesterday won pre-market approval from the FDA for its flagship Impella 2.5 heart pump sent the company’s stock soaring to an all-time high of $74.70 per share today.
ABMD shares closed up 18.0% at $72.48 on the news. The stock is up some 94% this year. Read more
FDA grants humanitarian use device status to fetal micro-pacemaker
March 27, 2015 by Brad Perriello
Comparative sizes of fetal
and adult pacemakers.
Click image to enlarge.
Researchers at Children’s Hospital Los Angeles and the University of Southern California said the FDA granted humanitarian use device status to the fetal micro-pacemaker they designed.
The device is the 1st fully implantable pacemaker for use in a fetus with complete heart block, according to a press release. The 1st implantation in a human is expected “in the near future,” the researchers said. Read more
Wright Medical wins FDA nod for Salvation external fixation device
March 26, 2015 by Mark Hollmer
Wright Medical snagged the FDA’s 510(k) clearance to start marketing a new external fixation device designed to position foot and ankle bones during surgery.
The Tennessee medical device company’s latest regulatory win is for its Salvation external fixation system, a metal exoskeleton made of tensioned thin wires, half pins and metal rings that helps position the foot and lower leg during surgery. Read more
FDA clears Stryker's Lite lumbar plating system
March 26, 2015 by Mark Hollmer
Stryker added another product to its spine division, following a new 510(k) clearance from the FDA.
Regulators gave their sign-off for the Kalamazoo, Mich.-based medical device company’s Lite Plate System, an anterior and lateral lumbar plate system designed to treat spinal conditions. It is made with 5 1-level slim lumbar plates and a state-of-the-art WingSpring locking mechanism, according to the company. Read more
