Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Onkos Surgical, Spirair, Venus Concept.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asept, Boston Scientific, Gopath, MMI, Nucleai, Sansure, Sepsmart, Spinex.
Richmond Hill, N.Y.-based Ihealthscreen Inc. reported the granting of a patent from the USPTO for automated systems for predicting and detecting the onset of glaucoma.
The U.S. FDA announced a class I recall of single-use neurovascular guide catheters made by Medos International Sarl SA of Neuchatel, Switzerland, because of fractures in the device’s distal catheter shaft. The FDA stated that the issue, seen in the company’s Cerebase DA line of guide sheaths, has led Medos to recommend that customers quarantine any of the affected devices, although a root cause has not yet been identified.
Life science companies and the Office of the U.S. Trade Representative have not always seen eye to eye on issues such as compulsory licensing, but industry might be supportive of a remark by U.S. Trade Representative Katherine Tai about companies that are provided with anticompetitive breathing by their host governments with noticeable anticompetitive effect.
Spirair Inc. won the race for the first U.S. FDA 510(k) clearance for a minimally invasive therapy for nasal septal deviation (NSD), the company said. The Septalign system features a bioabsorbable implant that enables minor cartilaginous septal deviation that can be placed in an office with local anesthesia.
“Traditional septoplasty and septorhinoplasty can require significant time away from work, with nearly 42% of patients requiring two weeks or more for recovery. With Septalign, recovery is much faster and requires little to no time away from work for recovery,” Spirair CEO Ben Bishop told BioWorld.
As with most common diseases of the developed world, aging is the major risk factor for developing cancer. Most of the half-dozen hallmarks of precancer that were published last week by investigators from Vanderbilt University and the Fred Hutchinson Cancer Research Center are also hallmarks of aging.
Unfortunately, scientists reported at the American Association for Cancer Research’s (AACR) 2024 annual meeting this week that accelerated aging is increasing, and may be driving an increase in early-onset cancers.
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