The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union.
Surmodics Inc., of Eden Prairie, Minn., said the U.S. FDA has granted a breakthrough device designation to its Sundance sirolimus-coated balloon (SCB) catheter to potentially help those suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.
The U.S. FDA has granted a breakthrough device designation for a new hemodialysis system from Fresenius Medical Care Holdings Inc. The device is designed to prevent blood blotting without the use of blood-thinning medication, such as heparin, that most dialysis patients require.
Garwood Medical Devices LLC's biofilm disruption device, Bioprax, has received breakthrough device designation from the U.S. FDA. Bioprax turns metal implants into electrodes and uses low-voltage electricity to eliminate the bacteria associated with biofilm infections.
The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time.
Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that.
The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.
The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.
Santa Clara, Calif.-based Shockwave Medical Inc. is working to build its business around the use of intravascular lithotripsy (IVL) in multiple arterial indications. Lithotripsy has been used to destroy kidney stones for decades, but now Shockwave's system is applying that technology to indications including coronary artery disease (CAD), above-the-knee peripheral artery disease (PAD) and below-the-knee PAD that each require a specific catheter.
