Medtronic won European regulatory approval for its Intellis system, which can be used for either spinal cord or peripheral nerve neurostimulation to help relieve chronic pain. This is currently the smallest implantable spinal cord stimulator on the market, which was released in the U.S. only a couple of months ago. The Intellis implant delivers bot (Read more...)
Tag: Neurosurgery
OptiScanner 5000 Cleared in U.S. for Continuous Glucose Monitoring in ICU
OptiScan Biomedical, a company based in Hayward, California, won FDA clearance to introduce its OptiScanner 5000 in the U.S. The device is intended for use in intensive care units to continuously monitor blood plasma glucose levels, something the OptiScanner 5000 can do accurately without having to be regularly calibrated. The device works via an i (Read more...)
Abbott Releases Proclaim DRG Dorsal Root Ganglion Stimulator for Chronic Pain
Abbott is releasing in the U.S. its Proclaim DRG neurostimulation system to fight chronic pain in patients with complex regional pain syndrome in their legs. The product consists of an implantable neuromodulator that stimulates the dorsal root ganglion (DRG), an Apple iPad for programming the device, and an iPod touch for the patient control of [&h (Read more...)
EchoPixel Lets Surgeons See CT, MRI, and Ultrasound Scans in 3D
Since the invention of the X-ray machine in 1895, medical imaging technology has improved dramatically, but the visualization of those images hasn’t changed enough to keep up. Even though CTs and MRIs capture 3D data, the consumption of that data by physicians is still almost entirely in 2D formats. EchoPixel, a company based in Mountain [&he (Read more...)
FDA Gives First Clearance to Siemens High-Field 7 Tesla MRI Scanner
Siemens Healthineers won FDA clearance to introduce its 7 Tesla MRI scanner, the MAGNETOM Terra. The device won European regulatory approval in August, kicking off an age of high-field MRI scanning that produces imaging details previously unavailable in a clinical setting. Previously, only scanners with a field strength of 3 Tesla were the most pow (Read more...)
Modus V High-Powered Robotic Neurosurgical Microscope Unveiled by Synaptive
Synaptive Medical, a Toronto, Canada firm, is releasing its Modus V digital robotic surgical microscope. The optical components of the microscope reside on a robotic arm, the technology in which is partially based on the Canadarm device on the International Space Station. The high powered microscope offers the greatest magnification of any comparab (Read more...)
LivaNova’s New SenTiva Neurostimulator for Epilepsy FDA Approved
LivaNova, a UK firm, won FDA approvals for its newest vagus nerve stimulation system for treating epilepsy in patients as young as four years old. The system, which includes the SenTiva implantable neurostimulator and the VNS Therapy Programming system, monitors brain activity and delivers therapy when it believes a seizure may be imminent. During (Read more...)
Olympus Releases ORBEYE 4K-3D Surgical Microscope System
Olympus is releasing its latest surgical microscope, the 4K-3D ORBEYE video microscope. The device was developed by a joint venture called Sony Olympus Medical Solutions. The system comes with an accompanying 4K-3D 55-inch monitor, allowing surgeons to look directly at the screen rather than a microscope eyepiece and for the rest of the clinic (Read more...)
World’s Densest Neural Probe to Power Brain-Computer Interfaces, Implants
Imec, a nanotechnology and digital technology research institution in Belgium, has developed the world’s densest neural probe. The ability to build ever more complex and capable brain-computer interfaces and neural implants requires being able to interface with as many neurons as possible. The new neural probe is so densely packed with electr (Read more...)
Mazor X Robotic Spinal Surgery System Cleared in Europe
Mazor Robotics, an Israeli firm, announced that its Mazor X Surgical Assurance Platform has received the European CE Mark of approval. The system, used to perfect spinal surgeries, is being co-marketed by Medtronic, which just invested $40 million into Mazor Robotics. The Mazor X consists of a pre-op software package that helps to establish a (Read more...)
Arkis CerebroFlo EVD Drainage Catheter for Cerebrospinal Fluid Cleared by FDA
Arkis BioSciences, a young medical technology company out of Knoxville, Tennessee, won FDA clearance for its CerebroFlo external ventricular drainage catheter. The device indicated for positioning within the ventricular cavity of the brain and establishing a drainage channel to release cerebrospinal fluid. The company touts the use of Endexo, (Read more...)
LessRay Radiation Reduction System for ORs Using Fluoroscopes
NuVasive, a company based in San Diego, California, is now making available its LessRay radiation dose-reduction system. It consists of a computer cart that connects to an operating room’s fluoroscopy system. The fluoroscope can be set to a lower level of X-ray exposure, and the LessRay, using its proprietary software algorithms, then correct (Read more...)
Medtronic’s Intellis Spinal Cord Neurostimulation System Released in U.S.
Medtronic won FDA approval and is releasing in the U.S. its Intellis spinal cord neurostimulation platform, which includes the world’s smallest fully implantable spinal cord neurostimulator. The system delivers both high-dose and low-dose therapy, depending on the patient’s needs, and tracks patient activity to help physicians impr (Read more...)
Medtronic Releases StealthStation ENT Surgical Navigation System
Medtronic is launching its new StealthStation ENT surgical navigation system for ear, nose, and throat procedures following both FDA and CE Mark clearances. The system works by setting up an electromagnetic field around the area being worked on, and then using this field as a coordinate system to accurately track the location of instruments. The [& (Read more...)
Leica Wins FDA Clearance for Novel Neurosurgical Microscopy Filter for Detailed View of Blood Flow
Leica Microsystems has announced that it won FDA clearance for its FL560 fluorescence microscope filter to be used with the dye fluorescein to view cerebrovascular blood flow. The filter works with the M530 OH6 neurosurgical microscope, and after injection of fluorescein the surgical team can see blood fluorescing in greenish/yellow while the rest (Read more...)
ClaroNav’s NaviENT FDA Cleared to Guide Endoscopic Sinus Surgery and Skull Base Surgery
ClaroNav, a company headquartered in Toronto, Canada, won FDA clearance for its NaviENT system that gives otolaryngologists information about the location of the tip of an instrument introduced during functional endoscopic sinus and skull base surgeries. During such surgeries, which are performed through the nose, the NaviENT shows the instrument t (Read more...)
Surgical Pen Can Identify Cancer in Real-Time
Researchers at the University of Texas at Austin have developed a hand-held surgical “pen” that can analyze tissue samples and tell a surgeon if they are cancerous in just a few seconds. During surgery to remove a tumor, surgeons need to know if they have removed the entire tumor margins, as leaving just a small […]
Neuropace Epileptic Seizure Control System: Interview with Dr. Martha Morrell, CMO of NeuroPace
People with certain types of epilepsy may have the option to use a therapy that doesn’t include drugs. The RNS system from Neuropace, a company out of Mountain View, California, monitors the brain for signs of an oncoming seizure and stimulates it to disrupt the process. It has been approved in the U.S. for about […]
MRI Inside Neonatal Intensive Care Unit: Interview with Uri Rapoport, CEO of Aspect Imaging
The smallest patients may require numerous imaging scans, including MRIs of the brain, in order to receive proper care so they can graduate from the neonatal intensive care unit (NICU). MRI machines are usually situated far away from the NICU, requiring moving fragile dependent patients sometimes across the entire hospital and up and down mult (Read more...)
EU Gives First Approval for Ultra-High-Field MRI Scanner, The Siemens Magnetom Terra
Siemens Healthineers just won the first European regulatory approval for an ultra-high-field MRI scanner to be used in clinical practice. The Magnetom Terra sports a magnetic field strength of 7 Tesla, which is considerably more powerful than 3 Tesla, the current high-end standard. MRIs of such strength have been used in research hospitals for year (Read more...)