4WEB Medical this week announced it received regulatory clearance for its Anterior Spine Truss System with Anchor Fixation (ASTS-AF). The Dallas-based orthopedic implant company’s current anterior lumbar implant offering includes a traditional interbody with the option of an integrated plate and a standalone interbody with screw fixation. The regulatory clearance expands the company’s portfolio to […]
Boston Scientific warns on some Vercise Genus implantable pulse generators
Boston Scientific recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators. In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. […]
FDA labels Outset Medical recall of Tablo hemodialysis system as Class I
The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind. The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA. Outset Medical recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching […]
FDA wants to advance health equity through home-based care
The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans. The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and […]
FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System
Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System. The Del Mar, California-based sacroiliac device company designed the device to incorporate intra-articular and transfixing components. BowTie minimizes tissue disruption, thoroughly prepares the joint, and provides rigid fixation to enable robust arthrodesis. “There hasn’t been meaningful differentiation in the SI […]
Front Line Medical wins CE mark for COBRA-OS device
Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device. The CE mark gives EU medical providers access to the Control Of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS). The device already has FDA clearance and Health Canada approval. “The CE marking of the COBRA-OS is momentous for our company, as […]
Vantage MedTech names Jim Bartel as CEO
Vantage MedTech today announced it appointed Jim Bartel as CEO. Bartel has more than 25 years of leadership experience within the medical device and contract manufacturing industries. He has held various roles in leading marketing, business development and sales teams. Most recently, Bartel was CEO and board member of Waltek, a private equity-owned casting and […]
Annoviant awarded $3M NIH grant for pediatric pulmonary-valved conduit
Annoviant recently announced it was awarded a $2.99 million National Institutes of Health grant to advance its TxGuard pulmonary-valved conduit for pediatric heart disease. The grant, an SBIR Phase 2 b grant, will help the Atlanta-based company accelerate the development and commercialization of its technology. It builds upon the company’s previous Phase 2 NIH grant […]
FDA approves Lumicell’s breast cancer visualization system
Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal. According to the company, the LumiSystem allows surgeons to scan the breast cavity post-lumpectomy in real time to detect and resect residual cancer that could have been missed with 84% diagnostic accuracy. The LumiSystem with the company’s LumiSight […]
Fresenius Kabi has a Class I recall of Ivenix Infusion System software
The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind. Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or […]
Viz.ai, NICO collaborate to improve intracerebral hemorrhage treatment
Viz.ai today announced a collaboration with NICO Corporation to help improve the lives of patients with intracerebral hemorrhages. Intracerebral hemorrhage (ICH) is caused by bleeding in the brain tissue and is a life-threatening type of stroke. It accounts for up to 15% of all strokes and has high morbidity and mortality rates. Viz-ai’s technology can […]