Aethlon Medical (NSDQ:AEMD) said today that it finished an FDA-approved feasibility study for its Hemopurifier device in health-compromised patients. Previously, the device was used under the FDA’s emergency-use authorization in patients infected with Hepatitis C, HIV and the Ebola virus. Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted […]
Food & Drug Administration (FDA)
Spineology wins expanded FDA clearance for Elite interbody fusion system
Spinal tech developer Spineology said today it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures. The Minneapolis, Minn.-based company said it won clerance for a narrower 10mm version of the device, as well as an extended indication allowing the device to be used with allograft bone. “The broader size […]
Medtronic wins FDA nod for next-gen Linq ICM
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection. The Linq ICM with TruRhythm Detection offers exclusive algorithms which the Fridley, Minn.-based company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the […]
Report: Gottlieb is Trump’s top pick for FDA head
Former FDA deputy commissioner Scott Gottlieb is the Trump administration’s top choice to head the agency, according to a Bloomberg report. Gottlieb has held several senior positions at the FDA during the George W. Bush administration, and has regularly spoken on plans to lower prescription drug cost through modernizing the federal watchdog’s approval process, according […]
Zoll Medical wins FDA PMA for Hospital Wearable Defibrillator
Zoll Medical said today it won FDA premarket approval for its Hospital Wearable Defibrillator. The Chelmsford, Mass.-based company’s HWD is designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation during hospital stays. The wearable device is designed to automatically detect and treat such events. “The HWD offers hospital care teams a […]
FDA warns of contaminated organ preservation solution
The FDA today warned of issues associated with contaminated SPS-1 static organ preservation solution from Organ Recovery Systems. The solution is intended for the flushing and cold storage of the kidney, liver and pancreas at the time of organ removal from the donor to prep for storage, transportation and eventual transplantation. Staff at a healthcare […]
Gore wins FDA nod, launches Viatorr Tips endoprosthesis in US
W.L. Gore & Associates said today it won FDA premarket approval for and launched its Viatorr Tips endoprosthesis with controlled expansion designed for transjugular intrahepatic portosystemic shunt procedures. The Newark, Del.-based company said that the newly cleared Viatorr Tips endoprosthesis is designed with proprietary ePTFE graft lining to minimize transmural permeation of bile and mucin. […]
Study: Streamlined regulatory pathway has not shortened approval times for drugs
A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times. The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a […]
FDA labels Physio-Control’s Lifepak 1000 recall as Class I
The FDA today labeled a select recall of Physio-Control Lifepak 1000 defibrillators over electrical issues as Class I. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The company’s Lifepak 1000 defibrillator is designed to […]
PolyPid wins FDA designation for antibiotic drug reservoir
Pharmaceutical company PolyPid said today that its D-Plex antibiotic drug reservoir won Qualified Infectious Disease Product status from the FDA. Under the designation, the Israel-based company’s product will be eligible for priority review, fast-track status and an additional 5 years of market exclusivity. Get the full story at our sister site, Drug Delivery Business News.
FDA warns of off-label balloon angioplasty to treat autonomic disorders
The FDA today released a safety communication concerning risks associated with off-label balloon angioplasty procedures intended to treat autonomic dysfunction, warning of serious health risks and a lack of supporting data. The procedure, called trans venous autonomic modulation, involves a catheter being threaded into a patients’ venous system where an attached balloon is inflated to […]