Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Concept Medical, Corvion, Miach Orthopedics.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Laboratories, Apollo Endosurgery, Aroa Biosurgery, Avenda Health, Biotronik, Miach Orthopaedics, Okami Medical, Spark Biomedical, Transenterix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Daiichi, Esperion, Durect, Hemoshear, Kite, Novartis, Regeneron, Thetis.
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