Minnesota medical device giant Medtronic (NYSE:MDT) was the 1st to notify doctors of potential issues with certain of its deep-brain stimulation implants, but the FDA’s response to the warning may have been something of an overreaction, according to some observers.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
SpinalMotion wins FDA panel review date for metal-on-metal artificial disc
Mountain View, Calif.-based medical device maker SpinalMotion will get its date with the FDA this summer, when a panel of experts will consider and make recommendations on the company’s Kineflex/C artificial disc.
On July 24, 2013, the FDA’s orthopedic & rehabilitation devices panel will review information on the Kineflex/C and made a recommendation on whether the federal watchdog agency should approve the device for the U.S. market.
Medtronic touts FDA win for cost-saving heart rhythm implants
FDA counterfeit detector to aid battle against malaria
Deborah M. Autor
By: Deborah M. Autor, Esq. and Melinda K. Plaisier
Allergan poised for 2013 launch pending novel FDA OK for facial filler
Delcath plunges after FDA panel recommends against liver cancer treatment approval
FDA gives Covidien recall highest-risk label
The FDA this week put its highest-risk label on medical device maker Covidien’s (NYSE:COV) recent ventilator battery recall, warning that the device may cause patients harm.
FDA gives Mauna Kea the green light for its optical biopsy miniprobe
Mauna Kea Technologies (ENT:MKEA) landed FDA clearance for its AQ-Flex 19 mini-probe, which is already on the market in Europe. The device is designed to biopsy pancreatic cysts during endoscopic needle aspiration procedures in the digestive tract.
Medtronic warns on wire damage risk with deep-brain stimulation implants
Medtronic (NYSE:MDT) warned physicians of the potential for the wires used with its deep-brain stimulation implants to be damaged during implantation, prompting the FDA to label Medtronic’s "Urgent Medical Device Correction" as a Class I recall – denoting a device with the potential to cause severe injury or death.
FLASH: FDA panel votes in favor of Allergan’s Juvederm Voluma XC facial filler
An FDA advisory panel voted today to recommend approval for Allergan’s (NYSE:AGN) Juvederm Voluma XC dermal filler for aesthetic volume restoration in the mid-face.
The FDA’s General & Plastic Surgery Devices advisory panel unanimously decided that the injectable gel is safe, effective and that its benefits outweigh its risks.
Spine Wave wins U.S. clearance for its body fusion device
Spine Wave won FDA clearance for its StaXx IB system, an intervertebral body fusion device. The privately held company said this expandable fusion device is differentiated from its flagship StaXx XD with the addition of bone graft chambers.