FDA gives the green light to Stimwave's mini spinal cord stimulator
December 3, 2014 by Mark Hollmer
Stimwave Technologies won the FDA’s 510(k) clearance for a wireless neuromodulation anti-pain device created with the idea that "smaller is better."
In fact, it’s quite tiny. The Miami-based company describes the Freedom spinal cord stimulation system as a tiny injectable microchip small enough – between 2cm and 11cm – to be implanted through a standard needle. An anchor helps keep it in place. Stimwave Freedom is also wireless, and can be implanted on an outpatient basis. It delivers small pulses of energy to electrodes near surrounding nerves in order to treat chronic back or leg pain. Read more
HeartFlow wins FDA OK for non-invasive FFR system
December 2, 2014 by MassDevice
HeartFlow yesterday said it won de novo clearance from the FDA for its non-invasive cloud-based cardiac imaging technology, which CEO Dr. John Stevens told MassDevice.com is the “most spectacular” innovation he’s seen during his 30 years in the medical device space.
HeartFlow’s FFRCT platform is an imaging approach that helps physicians treat coronary artery disease by getting a detailed look at the extent of blockage and blood flow. Read more
FDA warns AngioDynamics subsidiary Navilyst on hairs in PICC packaging
December 2, 2014 by Mark Hollmer
The FDA slapped AngioDynamics subsidiary Navilyst Medical Systems with a warning letter for selling some long-term-use catheters contaminated by hair and other foreign matter and for not properly addressing the issue, among other quality issues.
As many as 55 complaints came in between May 2012 and May 2014 alleging the presence of hair in catheter packing that was supposed to be sterile, the FDA said. Read more
Philips defib updates spur ConMed electrode recall
December 5, 2014 by Mark Hollmer
A ConMed recall of several lines of electrodes because they won’t work properly with some Royal Philips defibrillators was given the most-serious Class I designation by the FDA.
The FDA said changes made by Philips to the connector design of its FR3 and FRx automatic external defibrillators rendered some models of ConMed’s electrodes unable to work with those devices. Read more
FDA approves J&J spinal device for rare pediatric syndrome
December 8, 2014 by Val Kennedy
Johnson & Johnson’s DePuy Synthes Spine unit has won U.S. regulatory approval for a titanium rod device for the treatment of a rare congenital condition known as thoracic insufficiency syndrome.
The FDA awarded 510(k) market clearance for DePuy’s vertical expandable prosthetic titanium rib devices for TIS, which can cause severe deformities of the spine, chest or ribs. The devices were previously available to doctors through a humanitarian device exemption from the federal watchdog agency. Read more
