Vomaris Inc. introduced its U.S. FDA-cleared Powerheal bioelectric bandage for over-the-counter use following studies showing a shocking 99.99% reduction in bacteria present in wounds covered with the bandage even without the use of antibiotics. The bandage’s electrical energy also stimulates cell movement, cutting healing time in half, a study found. Read More
Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign. Read More
With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.” Read More
The long-term use of ventricular assist devices is becoming a problem for at least some of these devices, as demonstrated by the recall of the Heartmate II and Heartmate 3 devices by Abbott Laboratories’ Abbott Vascular division due to obstruction of the outflow graft used to attach the device to the human heart. Read More
The U.S. FDA granted fast track designation to Telix Pharmaceutical Ltd.’s TLX101-CDx for glioma imaging as the firm prepares to file its NDA in the first half of 2024, a Telix spokesperson told BioWorld. Read More
New hires and promotions in the med-tech industry, including: Cardiawave, Orthofix, Precision Optics, Ross Optical, Scientific Industries, Spark Neuro. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Annoviant, Biotricity, Butterfly Network, Ezra, Meta Dynamic, Omniscient Neurotechnology, Rayus, Simbiosys, Magic Leap. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Insightec, Xstim. Read More
