The FDA’s Center for Devices and Radiological Health (CDRH) released its latest top 10 regulatory science priorities yesterday. They are: Use Big Data to aid in regulatory decision-making. Modernize biocompatibility and biological risk evaluation of device materials. Use real-world evidence and evidence synthesis across multiple domains in regulatory decision-making. Advance tests and methods for predicting […]
BD to spend $8m to cut EO emissions in Georgia
Becton Dickinson (NYSE:BDX) said this week it will spend $8 million to upgrade emissions controls at two medical device sterilization plants it operates in Georgia. The plants in Covington and Madison, Ga., both southeast of Atlanta, use ethylene oxide (EO) to sterilize medical devices. The federal Environmental Protection Agency recognizes EO as a carcinogen and lowered […]
NAMSA workshop details new EU regulatory changes for medical device companies
Date/Time Date(s) – 09/19/2019 8:30 am – 4:30 pm EDT Location Hilton Crystal City at Washington Reagan National Airport Categories Training The EU’s new Medical Device Regulation (MDR), which entered into force on 26 May 2017, builds on the framework of the existing Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMD). Now […]
Former FDA commissioners want more funding for real-world evidence
Three former FDA commissioners are calling on Congress to fully fund the agency’s $60 million fiscal year 2020 budget for using more real-world evidence to evaluate drugs, biologics and devices. Most of that money — $23 million — is earmarked for medical devices. The document is titled “Expanding the Use of RealWorld Evidence in Regulatory […]
FDA lures Vyaire exec Desai for CTO | Personnel Moves, August 23, 2019
The FDA lured former Vyaire Medical executive Vid Desai to take over as permanent CTO, according to Politico. Desai replaces acting CTO Mohammed Sohail Chaudhry, who’s held the role on an interim basis since 2015. Ebb Therapeutics puts Röösli in the corner office Insomnia device maker Ebb Therapeutics said yesterday that it put Eduard Röösli […]
FDA warns Innovative Sterilization Technologies on marketing language
This article has been updated with a statement from Innovative Sterilization Technologies. The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes. Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical […]
Boston Scientific wins FDA nod for MR-safe Vercise Gevia DBS
Boston Scientific (NYSE:BSX) said yesterday that it won FDA approval for MR-conditional labeling on its Vercise Gevia deep-brain stimulation device for treating Parkinson’s disease. The ImageReady MRI label means the device and its companion Vercise Cartesia directional lead can be used during 1.5-Tesla full-body MRI scans, the Marlborough, Mass.-based company said. “Boston Scientific continually strives to […]
CVRx’s Barostim Neo system earns FDA approval
CVRx said today it won FDA approval for its Barostim Neo system, the world’s first heart failure neuromodulation device. The Minneapolis-based company’s device is designed to improve symptoms in patients with advanced heart failure who are not suited for other heart failure devices by electrically activating the baroreflex to reduce sympathetic activity and increase parasympathetic […]
FDA approves Zimmer Biomet’s pediatric spinal tether for scoliosis
Zimmer Biomet (NYSE:ZBH) said it received the first FDA approval for a spinal tether device intended to correct pediatric scoliosis. Warsaw, Ind.-based Zimmer Biomet’s tether is an anterior vertebral body tethering solution that uses a flexible cord as an alternative to metal rods. The cord is designed to pull on the outside of a scoliosis […]
BREAKING: FDA approves TAVR valves for low-risk patients
The FDA today expanded the approval for replacement heart valves made by Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) to include patients at low risk from open heart surgery. The expanded transcatheter aortic valve replacement approvals, for Medtronic’s CoreValve Evolut R and CoreValve Evolut Pro and Edwards’s Sapien 3 and Sapien 3 Ultra devices, widens the potential […]
Medtronic wins FDA approval for new extended-wear infusion set
Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently be […]
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