The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of selective laser therapy treatment (SLT) instead of eyedrops as treatment of chronic open-angle glaucoma (COAG) and ocular hypertension. The shift would seem to drive spending in the U.K. away from drugs and toward devices for a condition afflicting nearly 10% of citizens over the age of 75.
Inspan LLC has won FDA 510(k) clearance for an interspinous fixation system that can now be used to treat lumbar spinal stenosis in non-cervical spine cases of spondylolisthesis, trauma, tumor and degenerative disc disease. According to Aditya Humad, co-founder and CFO of Kicventures Group which counts Inspan among its portfolio companies, FDA clearance represents an expansion in the use of Inspan’s interspinous system into the “highly competitive space” of interventional pain management.
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetic Analysis.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Ambra Health, BD, Butterfly Network, Cognetivity, Conquer Scientific, Convatec, Cytognos, Genedit, Gentech, Ignite Data, Purity Scientific, Sarepta, Sera Prognostics, Triad Life Sciences, Twist Bioscience, ZS.
More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air.
With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.
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