FDA clears Intuitive Surgical's single-site da Vinci Sp robotic surgery system
April 22, 2014 by Brad Perriello
Intuitive Surgical shares recouped some recent losses today after the medical device company announced 510(k) clearance from the FDA for its da Vinci Sp single-site robot-assisted surgery platform in urological procedures.
It’s the 2nd FDA nod for Intuitive this month, following the April 1 clearance of its da Vinci Xi platform. Read more
FDA floats expedited approval for unmet needs
April 22, 2014 by Brad Perriello
The FDA today proposed a new regulatory option for high-risk medical devices that address unmet needs, aiming to speed access to the devices for patients.
The FDA said the “Expedited Access Pre-market Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions” would feature “earlier and more interactive engagement with FDA staff – including the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval.” Read more
Ulthera registers for $86M IPO
April 22, 2014 by Brad Perriello
Ulthera filed for a U.S. initial public offering yesterday, saying it hopes to raise as much as $86 million when it debuts on the NASDAQ stock exchange.
Mesa, Ariz.-based Ulthera makes an ultrasound device, which is designed to use the body’s natural healing process to non-invasively lift and tighten loose skin on the neck and under the chin. Read more
FDA may ban behavioral shock devices
April 23, 2014 by Arezu Sarvestani
The FDA’s neurological devices panel will meet tomorrow to decide the fate of aversive electrical stimulation, devices that generate electrical shocks used by care providers in order to deter unwanted behavior.
The agency will considering banning the use of “noxious” electrical behavior modification over concerns that the practice may pose “a substantial and unreasonable risk of illness or injury.” Only one U.S. institution, the Massachusetts-based Judge Rotenberg Center for special needs students, has recently manufactured and is still using electrical stimulation devices (ESDs). Their practices have drawn the ire of public interest groups as well as government watchdogs. Read more
Collaboration and medical countermeasures: Furthering regulatory science
April 22, 2014 by MassDevice
“I hope no one ever needs these products,” isn’t something you hear too often, particularly from those developing drugs, biologics, or devices. That point of view—and a universal desire to protect the American public—is what sets biodefense professionals apart.
Within FDA, our Medical Countermeasures initiative (MCMi) does things a little differently as well. Managed by the Office of Counterterrorism and Emerging Threats, in the Office of the Chief Scientist, MCMi thrives on collaborations. We work proactively with industry, academic and federal research centers, FDA product centers and offices, and other government entities in our mission to help protect the U.S. from chemical, biological, radiological, nuclear, and emerging infectious disease threats. Read more
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