LivaNova announced today that Symmetry, a device for vagus nerve stimulation (VNS) therapy, has received CE Mark approval for difficult-to-treat depression. Symmetry is a small device that stimulates the vagus nerve to improve symptoms of depression and quality of life. After surgical implantation, the device regularly sends mild electric pulses to (Read more...)
Author: Medgadged
Prosthetic Tech Lets Users Control Individual Fingers on First Try
Existing prosthetic hands have to rely on weak electrical nerve signals in order to know when to activate their motors. That’s because electrodes are typically placed on the skin over the area where the nerves end at the stump and the skin doesn’t transmit electricity that well. Implantable electrodes that make contact with the nerves [ (Read more...)
Phagenyx Helps Treat Difficulty Swallowing After Stroke
Dysphagia, or difficulty swallowing, can dramatically decrease a person’s quality of life and lead to poor nutritional intake. Neurological oropharyngeal dysphagia is due to damage to the nerves that control the muscles related to swallowing, often caused by strokes or other neurological conditions. The Phagenyx System is a neurostimulation d (Read more...)
Contact Lenses to Correct Color Blindness
Deuteranomaly is a color blindness that causes green light photoreceptors to react to redder light. Red objects seem greener for patients with the condition, but it has been known for a while that blocking some of the light in the red color range can improve proper color perception. There are glasses that do this, a […]
Masimo Receives FDA Approval for Continuous RRp Monitoring
Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) monitoring with its with Rad-97, Radical-7, and Radius-7 Pulse Co-Oximeters. Usually, monitoring respiration rate involves manually counting breaths with a timer or using chest straps that need to be fitted. The newly-approved Mas (Read more...)
V-Wave Shunt for Relief of Heart Failure Symptoms Cleared in EU
Heart failure patients often suffer from high pressure within the left side of their hearts, which can lead to difficulties breathing and other debilitating conditions. V-Wave, an Israeli firm, won the European CE Mark of approval for its Ventura interatrial shunt that aims to regulate left atrial pressure by creating a passage for blood to [&helli (Read more...)
ClotChip Receives FDA Breakthrough Device Designation for Real-Time Coagulation Testing
Cleveland-based XaTek Inc. announced receiving FDA Breakthrough Device designation for ClotChip, a handheld device that can measure a patient’s bleeding risk profile from a single drop of blood. The main advantage of ClotChip is that it produces results in 15 minutes, versus the many hours that traditional lab work currently takes. The dramat (Read more...)
Tivic Wins EU Clearance for ClearUP Sinus Relief Device
San Francisco-based Tivic Health announced that the company has received CE Mark approval in Europe for ClearUP Sinus Pain Relief, a small handheld device that can temporarily relieve allergy-related sinus pain, pressure, and congestion. ClearUP is a small handheld device that delivers a proprietary microcurrent waveform that stimulates s (Read more...)
Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve
Abbott announced that it received the EU CE Mark for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition which restricts blood flow through the valve. TAVR is particularly i (Read more...)
Aerin Medical Gets FDA Clearance for Nonsurgical Chronic Rhinitis Procedure
Aerin Medical, based in Austin, Texas, announced this week FDA clearance and US launch of the RhinAer Stylus, a device for nonsurgical treatment of chronic rhinitis. More than 30 million Americans suffer from nonallergic rhinitis, according to the company’s announcement. Symptoms can be disruptive, including runny nose, post-nasal drip, (Read more...)
iTind for Benign Prostatic Hyperplasia Gets FDA Green Light
Medi-Tate, based in Israel, has won FDA de novo authorization for its iTind system to treat benign prostatic hyperplasia. The minimally invasive system is used to implant and remove a nitinol device, during a five day outpatient procedure, which is used to continually push on the prostatic urethra and bladder neck to remodel them. The […]
CryoLife Wins EU CE Mark for E-vita Open NEO Hybrid Stent Graft
CryoLife, Inc., a company based outside of Atlanta, Georgia, announced this week that it has received the European CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease. Aortic arch disease encompasses both aortic aneurysms and aortic dissections, which occur suddenly and could be fatal. Ac (Read more...)
Jewel Wearable Cardioverter Defibrillator Could Help Prevent Sudden Cardiac Deaths
In the United States sudden cardiac death (SCD) claims 325,000 lives every year. SCDs are due to abnormalities in the conducting system of the cardiac tissue, resulting in arrhythmias, and can often occur after cardiac surgeries and other treatments. SCDs are medical emergencies, as cardiopulmonary resuscitation and defibrillation must be administe (Read more...)
Table-Top Robot Uses AI to Make Blood Draws, Insert Catheters
Researchers at Rutgers University have developed a robot that utilizes artificial intelligence, along with near-infrared and ultrasound imaging, to automatically make blood draws and insert catheters in small blood vessels. The device could take the guesswork out of blood draws, which are frequently challenging when performed manually, and reduce t (Read more...)
Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System
Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. The company also received approval for an Early Feasibility Study of the device for tricuspid and mitral valve regurgitation indications. The Cardiovalve transcatheter system is designed for treatment of mitral a (Read more...)
nView Medical’s Fast 3D Intraoperative Imaging with Less Radiation: Interview with CEO Cristian Atria
Fluoroscopy is used in surgical procedures to visualize structures and tools in real-time, allowing surgeons to monitor the movement of a device, instrument, or body part. However, fluoroscopy is a 2D technology that can lead to surgical inaccuracies. Alternative 3D imaging systems provide higher accuracy, but they sometimes require pausing the sur (Read more...)
Artificial Self-Assembled Blood Vessels
A team of researchers headed by groups at University of Nottingham and Queen Mary University London have come up with a smart material that forms into new blood vessels. Made out of graphene oxide and a protein, the material is 3D printed and naturally forms into tubular shapes that are very similar to blood vessels. […]
RESPMETER Opioid Overdose Detector Wins FDA Breakthrough Device Status
Altair Medical recently announced that it received FDA Breakthrough Device status for its RESPMETER wearable biosensor. The biosensor is a chest-worn wireless sensor that can detect Opioid Indused Respiratory Depression (OIRD), a common and often fatal side effect of using opioid drugs. The biosensor monitors respiratory patterns and analyses them (Read more...)
Aiber In-Flight Medical Emergency Response System
MIME Technologies, a startup originating at Aberdeen University in Scotland, unveiled the Aiber in-flight telemedicine system designed to be used by flight attendants to help stricken passengers. Using a tablet computer, flight attendants can communicate with physicians on the ground, transmitting observable symptoms, but also streaming data from s (Read more...)
On-X Ascending Aortic Prosthesis Cleared in EU
CryoLife, based in Kennesaw, Georgia, won EU regulatory clearance for the On-X Ascending Aortic Prosthesis (AAP) as a treatment option for people with poorly functioning aortic valves with a nearby ascending aortic aneurysm. The device, which combines a prosthetic valve and an ascending aortic prosthesis, can be implanted to address injured, damage (Read more...)