Toronto-based Titan Medical Inc. has inked a development and license agreement with Medtronic plc, of Dublin, to advance the development of single-port robotic-assisted surgical tools. A separate agreement gives Medtronic licensing rights to certain Titan intellectual property. The arrangement aligns with Medtronic’s goal of building its robotic-assisted surgery business and gives Titan’s financials a needed shot in the arm. Read More
The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155. Read More
Hydrocephalus involves the buildup of excess fluid in the brain. It affects more than 1 million people in the U.S. – most of them children – and can result in brain damage and related neurological impairments. Shunt implants are the standard treatment to drain that fluid, but more than half of them fail within the first couple of years of placement. Read More
During a massive disaster or a pandemic, securing the necessary manufacturing capacity, needles, syringes, vials, properly labeled caps, reagents and other supplies is as critical as the development of the product itself. Some experts have been warning about these needs since COVID-19 first began spreading outside of China. Now members of Congress are sounding the alarm. Read More
PARIS – Uromems SAS, of Grenoble, France, reported the completion of a series B round of $17.5 million to advance development of its implantable mechatronic device for treating stress urinary incontinence. Read More
New hires and promotions in the med-tech industry, including: Alcami, Inteliquet, Keona Health, Nevro, Oxford Biodynamics, Tandem Diabetes Care. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ace Surgical Supply, Discoverybiomed, Envisiontec, Facedrive, Fullerton Health, Med-El, Meditouch, Microbix Biosystems, Mölab, Mybio, Myolyn, Open Orphan, Rakuten Medical, R-Biopharm, University of Texas MD Anderson Cancer Center, Vapotherm, Zebra Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Roche, Synedgen, Transit Scientific. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Palmetto GBA, Procept Biorobotics. Read More
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of prostate cancer; Assay system identifies mitochondria-targeting drugs for PD; Ovarian organoids implicate oviducts. Read More
