From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows […]
Diagnostics
The top 10 medical disruptors of 2018
Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor or innovation is that it has to be innovative and could change care in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from […]
FDA warns Magellan Diagnostics on lead tests
The FDA today warned Meridian Bioscience (NSDQ:VIVO) subsidiary Magellan Diagnostics based on the Class I recall of its lead poisoning tests, accusing the company of failing to protect patients after it learned of problems with the tests. The May recall, which was expanded in July, involves Magellan’s LeadCare, LeadCare II, Ultra and Plus products. The tests may underestimate blood lead levels […]
7 medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]
The 11 most innovative medical devices of 2017
The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
These 7 antique medical devices will make you shudder
It’s a good thing we live in the times of modern medicine. Historically, medical devices have been scary and unorthodox – and sometimes amounted to downright quackery. Surprisingly, a lot of these devices were thought to be useful in their era, long before the U.S. FDA started preapproving devices (which wasn’t until the 1970s). You […]
How a smartphone app can detect concussions on the sidelines
A new app from the University of Washington could screen for concussions and other traumatic brain injuries from a smartphone. Researchers at the University of Washington are currently working to develop a smartphone app that can detect brain injuries when they happen. The app’s goal is to detect the injuries on the sidelines of sports […]
Cardiologs raises $6m in Series A to support ECG Analysis Platform
Cardiologs Technologies said this week it raised $6.4 million in a Series A round of financing to support accelerated commercialization of its Cardiologs ECG Analysis Platform in the US and Europe. Funding in the round came from a syndicate of new investors including Idinvest, ISAI, Kurma Partners and Partech and was joined by the previously vested […]
First test to screen blood donations for Zika virus wins FDA nod
The FDA today approved Roche Molecular System‘s (OTC:RHHBY) cobas Zika test, which detects Zika virus RNA in plasma specimens collected from volunteer blood donors and living organ donors. The test is designed to be used by blood collection establishments to detect Zika virus in blood donations – not for the diagnosis of Zika virus infection in […]
FDA clears Peerbridge Health’s Cor wireless ECG monitor
Health information technology company Peerbridge Health said this week it won FDA 510(k) clearance for its Peerbridge Cor wireless electrocardiogram monitor. The New York-based company claims the Cor has the smallest on-body footprint of any wearable monitor and provides multiple channels of ECG through water-resistant electrodes to enable continuous monitoring. Data from a clinical trial […]
Henry Schein inks distro deal with Cerebral Assessment Systems
Henry Schein (NSDQ:HSIC) said today it inked a deal with Cerebral Assessment Systems to distribute its Cognivue cognitive assessment screening device designed to detect early signs of dementia. Melville, N.Y.-based Henry Schein touted the Cognivue as the 1st such device approved by the FDA. The device is designed to allow practitioners to monitor current brain health and […]