Over the last six years, more than 20,000 patients have been implanted with the Sprint PNS system to manage acute or chronic pain, SPR Therapeutics Inc. reported. The 20,000th patient was treated for low back and leg pain with the Sprint Extensa XT system, which like the company’s other systems is implanted for 60 days in a minimally invasive surgery. The system uses percutaneous peripheral nerve stimulation (PNS) to recondition the central nervous system to provide long-term, significant relief from pain. Read More
The U.S. FDA is in the midst of a shake-up of several major offices, including the Office of Regulatory Affairs, but its commissioner, Robert Califf, believes there are even greater issues faced by the agency. Califf said during an Aug. 22 public forum that prices for generic drugs are too low to encourage manufacturers to continue to produce these products, adding that the issue is sufficiently severe to constitute a national security risk. Read More
Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive impairment, as well as the largest company in China in terms of revenue from the commercialization of cognitive impairment DTx products in 2022. Read More
Tandem Diabetes Care Inc. obtained reimbursement in France for its Control-IQ technology, an advanced hybrid closed loop system for patients with type 1 diabetes that uses an algorithm to automatically adjust insulin in response to predicted glucose levels. Read More
The process of discovery is resource-consuming in any type of litigation, but this is especially the case for patent litigation due to the exceptional importance of attorney-client privilege in patent prosecution. However, a U.S. judicial advisory committee is considering a rewrite of the rules to ease some of this burden in a move that could cut both the expense and time consumed by patent litigation, a development that is sure to draw cheers from across the spectrum of innovators in the life sciences. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Convergent Genomics, Neuraxis, Prostatype Genomics, Veracyte.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Grander Acquisition, Magenta Medical, Myomo, Polarityte, Regenetp, Sophia Genetics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Levita, Regenesis, Wenzel Spine. Read More
