Hologic (NSDQ:HOLX) said recently that it won FDA 510(k) clearance for its Quantra 2.2 breast density assessment software and that it inked a development and distribution deal with Clarius Mobile Health for its wireless, handheld ultrasound scanner. The Marlborough, Mass.-based company said the Quantra 2.2 software uses a proprietary algorithm to analyze mammography images for the […]
510(k)
7 medtech stories we missed this week: Nov. 17, 2017
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher
Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus. The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in […]
FDA clears Innovative Health Solutions opioid withdrawal treating neuromod
Innovative Health Solutions won FDA clearance for a new indication for its NSS-2 Bridge device, now cleared to reduce symptoms of opioid withdrawal, according to an FDA release. The NSS-2 Bridge device is a small electrical nerve stimulator designed to be placed behind a patient’s ear and emit electrical pulses to stimulate branches of certain […]
MedShape wins FDA nod for DynaNail XL TTC fusion system
MedShape said today it won FDA 510(k) clearance for its DynaNail XL TTC fusion system designed for tibiotalocalcaneal fusion surgery. The DynaNail XL TTC system is designed to better accommodate patients with longer tibial anatomies and treat tibial fractures, the Atlanta-based company said. The system is available in 260 mm and 300 mm lengths and includes […]
7 medtech stories we missed this week: Nov. 3, 2017
From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed […]
BRH Medical wins FDA nod for electro and ultrasound wound treatment system
Medical device developer BRH Medical said today it won FDA 510(k) clearance for its BRH-A2 device designed to reduce pain and improve deep wound healing through the use of ultrasound and electric fields. The Israel-based company’s BRH-A2 device is designed to engage and stimulate the wound from below the wound bed using both an ultrasound […]
FDA clears Abbott’s Alinity diagnostic analyzers
Abbott (NYSE:ABT) said today it won FDA 510(k) clearance for its Alinity instruments for clinical chemistry and immunoassay diagnostics. The newly launched ci-series of Alinity devices includes improvements such as smaller footprints, improved workflow capabilities and reduced wait times and simplified designs for error proofing and enhanced usability, the company said. “Healthcare systems across the United States are under […]
FDA clears Butterfly Network’s iQ ‘ultrasound-on-a-chip’
Medical device developer Butterfly Network said today it won FDA 510(k) clearance for the Butterfly iQ Apple (NSDQ:AAPL) iPhone-connected Ultrasound system, which claims is the world’s first ultrasound-on-a-chip system. The device is now indicated for 13 clinical applications, which the Guilford, Conn.-based company touts as the “broadest every for a single ultrasound transducer.” “Offering a unique blend […]
OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years
Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system. Get the […]
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 […]