Devicor touts FDA nod for its next-gen breast biopsy system

December 14, 2012 By MassDevice staff Leave a Comment

Cincinnati, Ohio-based Devicor landed FDA approval for its Mammotome revolve biopsy system, a next-generation biopsy system designed to provide high quality tissue specimens while improving the efficiency of pre-biopsy planning time.

The Mammotome system features specimen management for collecting and organizing high quality individual tissue samples in numbered, as well as specimen radiograph and pathology-ready chambers to preserve tissue integrity. The less invasive DualVac vacuum technology also helps clinicians secure larger contiguous tissue samples, according to the press release.

"Mammotome revolve uses breakthrough technology that offers peace of mind for clinicians and the patients they treat. With this new product, clinicians can be confident that patients are more likely to have a less painful and traumatic experience," president & CEO Tom Daulton said in prepared remarks. "The success of our recent new product innovations demonstrates why Mammotome is the undisputed worldwide leader in the field of vacuum assisted breast biopsy."

The company said that more than 1.4 million women in the U.S. experienced a biopsy procedure in 2011 and 40% of them underwent vacuum-assisted breast biopsies, according to the press release.

Over 4 million women worldwide have had successful breast biopsies with Mammotome biopsy system since 1995, the company said.

The Mammotome revolve device is available via a limited market release in the U.S., Canada and Europe. The company expects to receive full market clearance by next spring.

With more than 30 speakers, 25 panels and 4 tracks, you can't miss DeviceTalks Minnesota

On June 4-5, DeviceTalks Minnesota is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring.

Join leaders from 3M, Abbott, Bigfoot Biomedical, Boston Scientific, Cardionomic, CMF Solutions, Cyient, Google Mayo Clinic, Medical Alley, Medtronic, NxThera, Opus College, Relievant Medsystems, University of Minnesota, Star Tribune, Smith & Nephew, Spry Health, Zimmer Biomet and many more when you register today.

Use the code "DTWeb" to save 15% on the cost of registration.

REGISTER TODAY

Razorleaf opens first international division
Razorleaf (Stow, Ohio) announced that it has opened its first division outside of the U.S. in Northampton, U.K. The company’s new Razorleaf Europe will provide a single delivery and support service to customers in Europe. “We’ve already done projects in Europe, and have customers with both U.S. and European presence, but as we get into […]
MedAccred adds plastic extrusion to audit criteria
MedAccred recently announced that it has added plastics extrusion to its list of audit opportunities. Companies that want accreditation from MedAccred can now audit plastics extrusion in addition to cable and harness, heat treating, plastics injection molding, printed circuit board assembly, sterilization and welding. The audit criteria is developed from leaders in the medical device […]
This augmented reality system projects medical images on the body
Augmented reality is helping doctors visualize what’s inside the body without having to pick up a scalpel, thanks to a new system from the University of Alberta. The system ProjectDR projects medical images like CT scans and MRI data directly onto a patient’s body in a way that moves with the body. “We wanted to […]
What is a left ventricular assist device and how does it work?
What is a left ventricular assist device? A left ventricle assist device (LVAD) is a mechanical pump that attaches to the left ventricle of the heart to supplement the function of the pumping chamber, according to Jodi Hutchins, a regulatory and quality consultant at Proven Process Medical Devices. The left ventricle of the heart is responsible […]
How video games could take market share from big pharma
Tracy MacNeal, Ximedica At the Biotech Showcase in January, a panel discussed how video games are replacing drug therapies in a variety of diseases. If you haven’t seen the latest technology in this space, companies like Akili are providing drug-alternative therapies to kids with ADHD and Pear Therapeutics’ software is aimed at helping people with addiction. Technologists have reached incredible heights in getting people to […]
Tomorrow is Medical Alley Day in Minnesota
Minnesota Gov. Mark Dayton has declared tomorrow as Medical Alley Day in the state — the same day the state’s Medical Alley Association is holding its annual meeting in downtown Minneapolis. The North Star State is one of three major medical device hubs in the U.S., the other two being California and Massachusetts. Dayton noted in his […]
Nelson Labs expands lab operations at Illinois facility
Nelson Labs recently announced that it has invested in expanding its operations and service capabilities at its Itasca, Ill. facility. The investment will offer upgrades to the laboratory facilities, in addition to a 10,000 sq. ft building expansion and renovated lab space. The upgrades will include a BI sterility suite to support EO sterilization validations […]
DARPA is developing nonsurgical neural interfaces to expand neurotechnology
Researchers from the Defense Advanced Research Projects Agency (DARPA) have recently started a new program called Next-Generation Nonsurgical Neurotechnology to develop a non-invasive brain-system communications system to allow patients to communicate with devices using their brain. State-of-the-art brain communications systems that exist today are traditionally invasive, but allow for precise, high-quality connections to specific neurons […]
How Minnesota got a Pediatric Device Innovation Consortium
FDA funds a handful of pediatric device innovation groups around the United States. But Dr. Gwenyth Fischer, director of The Pediatric Device Innovation Consortium at the University of Minnesota, thinks there’s something that sets the seven-year-old group apart. The Minnesota group, Fischer said, is focused not only on funding but on getting doctors and other academics […]
Zeiss adds Xradia Context microCT to X-ray portfolio
Zeiss has launched its new X-ray imaging instrument the Xradia Context microCT, which is a large field-of-view, non-destructive 3D X-ray microcomputed tomography system. The new Zeiss system is a tomographic imaging solution for 3D characterization and inspection needs for a variety of applications. The system allows users to easily adjust the system to enable imaging […]
Medtech stories we missed this week: April 20, 2018
From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute […]