A new customizable robotic heart sleeve has demonstrated potential when it comes to aiding the beating of a failing heart, according to the Harvard University and Boston Children’s Hospital researchers who developed it. The researchers claim that the soft robot has advantages over the heart assist devices such as VADs that are out there because […]
Medtech sits on the sidelines as ACA repeal looms
Some major medical device industry lobbying groups are staying mum for now about the expected repeal of the U.S. Affordable Care Act—even though an extensive overhaul of the national healthcare system would have a serious impact on medtech. With so much unpredictability around how the incoming Trump administration and the new Republican Congress will replace […]
FDA’s CDRH reveals guidance plans for FY2017
Heather Thompson, MDO senior editor CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for […]
Touch Surgery simulations are even more amazing: Here’s how
Touch Surgery, which already boasts a community of 1.5 million using its mobile surgical simulations, is upping its game when it comes to making the platform even more immersive. Touch on Friday announced a partnership with DAQRI to add augmented reality capabilities to the simulations using DAQRI smart glasses. Here’s a sample from Touch Surgery […]
Boston Sci giving lift to new erectile dysfunction device
Want to put some lead in your pencil? Try nitinol instead. The wonder metal—a nickel-titanium alloy with heat-activated shape memory—has proved essential for Wisconsin and Illinois researchers building what British tabloids are calling a “bionic penis.” Chuckles aside, the proposed implant has enough potential advantages over existing erectile dysfunction treatment implants that Boston Scientific officials […]
Luminex wins FDA nod to test for dangerous pregnancy infection
Luminex continues to rack up FDA clearances for assays to use in its Aries systems. The Austin, Texas–based company said Wednesday that FDA has cleared an Aries assay for group B streptococcus. It’s the third assay FDA has cleared for use with Luminex’s Aries systems. The GBS assay has also received a CE-IVD marking. Luminex […]
GE plans to dominate 3D printing: Here’s how
A new big gorilla has entered the 3D printing space, and it is called General Electric. GE said Wednesday that GE Additive will work with GE Capital to both sell and finance metal additive machines. The news is but another sign of just how important officials at the multinational industrial company view 3D printing’s potential […]
University of Virginia has a smartphone-controlled artificial pancreas
Danielle Kirsh, MDO Assistant Editor University of Virginia researchers are making strides when it comes to developing an artificial pancreas that can be controlled using a smartphone. The FDA approved the UVA-developed artificial pancreas for testing in 2012, and UVA received a $3.4M grant from the National Institutes of Health in 2013. The device is currently […]
CES 2017: Medical technologies you should check out
Danielle Kirsh, MDO Assistant Editor The year’s biggest tech event—the annual Consumer Electronics Show—is slated to start Thursday in Las Vegas. Expect eye-popping television displays, driverless cars, wireless audio and, of course, a host of wearables and other mobile health devices. The surprises that turn up on the show floor can often be the biggest […]
Changing your medical device: What you need to know
When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]
FDA issues final guidance on ’emerging signals’
FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week. The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to […]