As expected, the FDA's Vaccines and Related Biological Products Advisory Committee voted near-unanimously on Dec. 17, with one abstention, that available evidence shows the benefits of Moderna Inc.'s COVID-19 vaccine, mRNA-1273, outweigh its risks for people 18 and older. The vote bolsters the likelihood that the regulator will grant the vaccine an emergency use authorization (EUA), which could come as soon as Friday. Not the same as an approval, the authorization would allow for the vaccine's use for the prevention of COVID-19 in the U.S. even as further trials and regulatory evaluation remains underway ahead of a company BLA submission.
The U.S. FDA granted a breakthrough device designation to Exero Medical Ltd.’s implantable smart sensor for early detection of anastomotic leaks after gastrointestinal (GI) surgery. The device continuously monitors the GI tract near the surgical site to alert providers about potentially deadly leaks.
Bone Health Technologies Inc. may be on the verge of upstaging a common drug therapy, but don't tell them to break a leg. The San Francisco-based company's Osteoboost Vibration Belt received a U.S. FDA breakthrough designation for technology that delivers gentle stimulation to reduce bone loss and prevent osteoporosis with the goal of reducing the number of potentially devastating broken bones in the elderly.
The U.S. FDA has granted breakthrough device designation to Spark Biomedical Inc. for its Roo system, a transcutaneous electrical nerve stimulator to assist newborns with opioid withdrawal. The noninvasive neurostimulation device is modeled on the company’s Sparrow Therapy System for adult opioid withdrawal relief.
The U.S. FDA’s intended use rule has been in flux for the past half-decade, with yet another draft rule making the rounds for comment. Despite any concerns that speech regarding off-label use might again be seen as a primary driver of prosecution, Sara Bloom, senior litigation counsel at the U.S. Department of Justice’s District of Massachusetts office, said distribution of the product in question is frequently the key feature where federal prosecutors are concerned. Bloom said communication of off-label use often serves primarily as a confirmatory element of the manufacturer’s intent rather than as the decisive part of the prosecution’s case.
Sonalasense Inc., a company working in the field of sonodynamic therapy, is collaborating with the Ivy Brain Tumor Center at Barrow Neurological Institute to conduct a first-in-human clinical trial of its noninvasive sonodynamic therapy for the treatment of recurrent glioblastoma multiforme (rGBM). The sonodynamic platform technology uses a dual approach with aminolevulinic acid (ALA) and MRI-guided focused ultrasound to target glioblastoma cells for destruction.
Several hospital and pharmacy groups, including the American Hospital Association, filed suit last week in the U.S. District Court for the Northern District of California in an effort to force the Department of Health and Human Services to stop drug companies from “undermining” the 340B prescription drug discount program.
Corrective and preventive action (CAPA) has a long and difficult history where med tech is concerned. Kathryn Merrill, the global quality/regulatory program director for Medtronic plc, of Dublin, said on a recent webinar that one of the main sources of uncertainty is that many in industry are not clear as to which circumstances dictate that a CAPA should be opened.
TORONTO – The Medipines AGM100, which was developed by Orange County, Calif.-based Medipines Corp. to detect respiratory impairment caused by chronic obstructive pulmonary disease (COPD), has been recruited in the fight against COVID-19 in Canada. Described by company CEO and coinventor Steve Lee as “the world's first noninvasive lung monitor for gas exchange measurement,” the device is undergoing advanced testing.
A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup.
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