San Clemente, Calif.-based Glaukos Corp. reported 22% net sales growth to $65.8 million in the final quarter of 2019, up from $54.1 million in the same period a year ago. However, it also warned that increasing competition in the microinvasive glaucoma surgery (MIGS) space could dampen 2020 growth in its U.S. glaucoma business. Speaking with analysts on a fourth-quarter earnings call, CEO Thomas Burns said good conversion rates and growing surgeon interest in its next-generation trabecular bypass device, Istent Inject, may not be enough to counter the headwind. Read More
The U.S. FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition (CPC) says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting (CPAM). It added that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process. Read More
Over the last few years, Wall Street has fervently embraced the largest diabetes technology companies, particularly those behind continuous glucose monitors, insulin pumps, and the automated closed loop systems that incorporate both to work together. Read More
TORONTO – Montreal’s McGill University and the Montreal Neurological Institute-Hospital (The Neuro) have entered a research agreement with Pasadena, Calif.-based Fuzionaire Diagnostics Inc. to detect and treat neurodegenerative diseases through molecular imaging. Read More
SAN JOSE, Costa Rica – Two decades ago, the Costa Rican economy was basically an agriculture-based economy. Since then, the tiny Central American country has emerged as the second-largest med-tech exporter in the region as well as an eager partner and supplier of skilled manpower. Read More
Beyond every binary is a more complex reality. And so it is with driver and passenger mutations. The separation of tumor mutations into drivers and passengers underpins much progress in the development of targeted therapies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphatec Holdings, BGI, Cetius Tech, Clearsense, Complete Genomics, Cytosorbents, Eos Imaging, Illumina, Labvantage Solutions, Leica Microsystems, Master Dynamic, MGI, Nevro, New World Development, Perkinelmer, Stimwave Technologies, Surgicalone, Transenterix, Verato. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Companion Medical. Read More
Keeping you up to date on recent developments in neurology, including: Multisensor band developed to record subtle changes in patients with MS; Study finds surveillance after glioblastoma surgery does not improve outcomes; New CRISPR base-editing technology slows ALS progression in mice; Resetting immune cells improves TBI recovery in mice. Read More
