Boston Scientific wins CE Mark, FDA nod for spinal surgical leads
October 21, 2014 by Brad Perriello
Boston Scientific said it won FDA and CE Mark approval in Europe for its CoverEdge 32 and CoverEdge X 32 surgical leads, touting them as the world’s 1st 32-contact leads for treating chronic pain.
The CoverEdge leads are designed to be used with Boston Scientific’s Precision Spectra spinal cord stimulator, according to a press release. Read more
ReFlow has new Wingman35 in U.S. market
October 23, 2014 by Alexander Soule
On the heels of CE Mark approval in Europe, ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter and said it has already been used in California vascular clinics.
The Wingman35 is indicated for use in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature and enable rapid, routine, off-the-shelf lesion crossing. Read more
Auditors: FDA needs to boost cybersecurity
October 23, 2014 by Val Kennedy
Federal auditors have determined the FDA needs to ramp up its cybersecurity efforts in order to deter hackers.
Auditors for the U.S. Health & Human Services Dept.’s Inspector General’s Office tested many of the FDA’s IT systems in the wake of a security breach last October that exposed approximately 14,000 user accounts. Read more
Life Spine creates Centric Medical ankle & foot unit
October 23, 2014 by Alexander Soule
Life Spine launched a new division called Centric Medical, after receiving FDA marketing clearance for its Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in the foot and ankle.
The Tarsa-Link device consists of a polyetheretherketone wedge with integral bone screws for procedures including surgeries for bunions and flat feet, according to a press release. Read more