Cardiology
Cardiology
Cardiology
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...
Cardiology
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...
Cardiology
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...
Cardiology
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...
Cardiology
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...
Cardiology
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...
Cardiology
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...
Cardiology
New HydroPICC Prevents Clogged Central Line Catheters
Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its HydroPICC anti-thrombogenic central line catheter. As with the original, which was cleared two years ago, the new device features Access's unique...
Cardiology
FDA Clears First Pulse Oximeter to Measure Breathing Rate
Masimo just received the first FDA clearance for a fingertip pulse oximeter that can measure respiration rate. The MightySat Rx spot-check pulse oximeter includes a technology known as Respiration Rate from the Pleth (RRP) that makes it...
Cardiology
