In game-changing news for parents of children with cerebral palsy, researchers demonstrated significant clinical improvement in the sensorimotor function of children who underwent sessions using Spinex Inc.’s Spinal Cord Innovation in Pediatrics (Scip) therapy. With current treatment options limited to physical therapy, medication and/or surgery, Parag Gad, co-founder and CEO of Spinex, told BioWorld he believes that Scip therapy “can be the new standard of care” for children with cerebral palsy. Read More
The U.S. FDA recognized several new standards for sterilization of medical devices as part of an effort to reduce the use of ethylene oxide (EtO) for this purpose. While the recognition may stimulate adoption of alternative methods, Congress is applying yet more pressure on the EPA to act more decisively in regulating EtO, thus amplifying pressure on a system that device makers believe is already under stress. Read More
With more drugs for Alzheimer’s disease (AD) gaining FDA approval and an aging population at increased risk of dementia, the need for AD diagnostics is only going to grow. An estimated 6.7 million Americans live with Alzheimer’s today, with that number projected to hit 14 million by 2060, according to the CDC. Read More
Quantum Genomics SAS recently entered exclusive talks with Vistacare Medical SAS to create a leading player in complex wound management. “Vistacare Medical’s innovative contactless treatment technology, our financial backing and stock market listing, and the complementary nature of our two teams will enable us to accelerate the development of this new medical device on an international scale,” Jean-Philippe Milon, CEO of Quantum Genomics SAS, told BioWorld. Read More
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID). Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Body Vision, Cue, Femasys, Hemosonics, Invo, Kral Medical, Prism Technologies, Paragon Care, Shockwave Medical, Tandem. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irhythm Technologies, Quanta Dialysis Technologies. Read More