FDA news: Covidien, Preventice, Precision Spine win FDA clearances

September 11, 2012 By MassDevice staff

A trio of medical device companies won nods from the FDA’s Center for Devices & Radiological Health this week, including a surgical sealer, a wireless cardiac monitor and a spinal plating system

Covidien (NYSE:COV) said it won 510(k) clearance from the FDA for its LigaSure surgical sealer/divider for ear, nose and throat procedures.

The clearance means the device, which is designed to be small enough to successfully maneuver during ENT procedures, can be used in thyroidectomies, parotidectomies and open ENT procedures. More than 160,000 such operations are performed annually in the U.S., according to a press release.

Minneapolis-based Preventice won a 510(k) nod for the BodyGuardian Remote Monitoring System it co-developed with the Mayo Clinic, using peel-and-stick sensor technology licensed from Proteus Biomedical partner Avery Dennison, mobihealthnews reports.

The system is a small body sensor that attaches to the patient’s chest to track ECG, heart rate, respiration and activity level, according to the website. BodyGuardian continuously records, stores, and periodically transmits the data for up to 30 days at a time and "detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional," according to an FDA filing.

And Precision Spine said its Spine USA subsidiary won 510(k) clearance for its Slimplicity solo anterior cervical plate system.

Performance Motion Devices touts new Juno outer loop control ICs
Performance Motion Devices announced the launch of its Juno outer loop control ICs for use in medical, industrial and military applications. The Westford, Mass.-based company’s new Juno product joins a portfolio of velocity and toque control ICs (integrated circuits) used for spindle control, centrifuge control, precision torque control and other liquid handling and laboratory automation… […]
Lille Group releases Cardiac Signals cloud-based patient monitoring software
Lille Group announced today that it launched its Cardiac Signals cloud-based software platform for healthcare professionals to monitor cardiac patients remotely. The secure platform enables cardiology practices and hospitals to manage cardiac patients remotely with ease and efficiency, which is aimed to help during a potential telehealth boom as the COVID-19 pandemic continues and onsite… […]
The secret to building a successful medtech career
In this week’s DeviceTalks Weekly podcast, Edwards Lifesciences executive Dr. Todd Brinton shares the one trait he looks for in job candidates that can trump talent and ability. Brinton, who is VP of advanced technology and chief scientific officer at Edwards Lifesciences (NYSE:EW), also offered tips on when candidates need to shift from conforming to differentiating.… […]
Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment
Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19. ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic… […]
Using gold nanoparticles to detect COVID-19
Scientists from the University of Maryland School of Medicine have developed an experimental diagnostic test for COVID-19 that they say can visually detect the presence of the virus in 10 minutes. It uses a simple assay containing plasmonic gold nanoparticles to detect a color change when the virus is present. The test does not require… […]
Jama Software debuts medtech software
Jama Software (Portland, Ore.) announced this week that it has introduced new software for medical device development. The company described Jama Connect as a solution designed to help engineering teams better manage device requirements, risk and design control. The new software is also designed to make regulatory submissions and audit preparations a straightforward process and… […]
Could this fabric protect against a strain of coronavirus?
Noble Biomaterials announced today that third-party testing showed one of its metallized fabrics reduced the viability of a common, strong strain of coronavirus. In testing conducted by BioScience Laboratories, Noble Biomaterials’ X-Static fabric reduced the survival of human coronavirus OC43 six times faster than the unmetallized control fabric, according to the Scranton, Pa.-based company. X-Static… […]
How gas and liquid valves improve medtech performance and efficiency
While the miniature solenoid valves might be simple in their core technology, their continued evolution makes them valuable and effective components for controlling the flow, direction and pressure of gases and fluids in today’s medical devices. Paul Gant, Emerson Automation Solutions With automated functions, excellent reliability and long life, it’s no surprise that gas and liquid… […]
Astrodyne TDI and Digi-Key Electronics join forces
Power supply and EMI filter manufacturer Astrodyne TDI announced today that it has joined Digi-Key Electronics’ DK+ Marketplace, a new B2B electronics sales site open to suppliers and distributors to offer their products and services on DigiKey.com. This new venture will make Astrodyne TDI’s medical and industrial power solutions available for immediate delivery to Digi-Key’s engineering… […]
How to meet challenges with innovative machining
CNC is a technique for automating control of machine tools using software rooted in a microcomputer affixed to the tool. It is frequently used in manufacturing for machining metal and plastic parts. John Cross, Micro Data drive the accuracy and efficiency of the computerized numerical control (CNC) machines coming onto the market today. The latest… […]
Vexos to manufacture 10,000 ventilators for Canadian COVID-19 patients
Electronics manufacturer Vexos said this week that it has signed an agreement with the government of Canada to manufacture 10,000 mechanical ventilators for COVID-19 patients in that country. The LaGrange, Ohio-based company said it will build the ventilators, known as Mechanical Ventilator Milano (MVM), under an exclusive license agreement with Elemaster Group for the Americas. Vexos said… […]