OptiScan Biomedical said today that its OptiScanner 5000 glucose monitoring system won 510(k) clearance. The device is the first of its kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical intensive care units. Get the full story at our sister site, Drug Delivery Business News.
510(k)
Stryker wins FDA nod for cementless Mako total knee system
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its cementless Mako total knee system with Triathlon Tritanium. The Kalamazoo, Mich.-based company touted the Triathlon Titanium as combining kinematics from its Triathlon knee with highly porous biologic fixation technology. The system features the company’s Tritanium tibial baseplate and metal-backed patella components as well, the company said. […]
Philips wins FDA 510(k) for small parts ultrasound transducer
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its eL18-4 ultrasound transducer designed for ‘small parts’ assessments to detect abnormalities in small organs close to the skin. The Amsterdam-based company said the device is part of its Ultimate Small Parts Solution which also features the company’s MicroFlow Imaging, Elastography and Precision Biopsy technology. […]
7 medtech stories we missed this week: Oct. 13, 2017
From Orthocell’s distribution deal to CorNeat unveiling its artificial cornea, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. OrthoCell inks Australian distro deal Orthocell announced in an Oct. 10 press release that it has signed a distribution deal with Surgical Specialities. The deal will make Surgical Specialities the […]
FDA expands indications on NuVasive’s Precice magnetic limb lengthener
NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for tis Precice magnetic limb lengthening system, now cleared to include open and closed fracture fixation, psuedoarthrosis, malunions, nonunions and bone transport. The San Diego, Calif.-based company’s Precice system is designed to treat patients with limb length discrepancy, limb deformities and chronic nonunions and consists of […]
7 medtech stories we missed this week: Oct. 6, 2017
From Intellijoint’s CE Mark to Patrona Medical and Kopis’ new partnership, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intellijoint CE Mark for flagship hip navigation Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in […]
FDA issues new user fee guidances
The FDA has released seven new, or updated, guidance documents relating to its user fee programs and performance goals outlined in the fourth version of the Medical Device User Fee Amendments. In MDUFA IV, FDA agreed to accelerate approval decisions for most medical device submissions. In exchange, user fees were bumped up and a new […]
Adhezion Biomedical wins FDA nod for SecurePort IV cath adhesive
Adhezion Biomedical said today it won FDA 510(k) clearance for its SecurePortIV catheter securement adhesive. The Wyomissing, Penn.-based company said the SecurePortIV adhesive can be used with short-term or long-term vascular access devices to improve securement, seal catheter insertion sites, protect from catheter related blood stream infections and provide a water-resistant barrier. “SecurePortIV is the only […]
Nexxt Spine wins FDA nod for Nexxt Matrixx interbody, VBR devices
Nexxt Spine said today it won FDA 510(k) clearance for its Nexxt Matrixx platform of interbody and vertebral body replacement devices. The Noblesville, Ind.-based company said the Nexxt Matrixx system is composed of porous titanium devices designed with open architectural porosity, residue-free surface tech and “robust radiographic imaging performance.” “The Nexxt Matrixx system applies breakthrough […]
Pulse Biosciences raises $30m in private placement
Pulse Biosciences (NSDQ:PLSE) said today that it agreed to sell 2 million of the company’s common stock at $15.02 apiece to investor Robert Duggan in a $30 million private placement. The company plans to use the net proceeds from the private placement for working capital or other general corporate purposes, according to a regulatory filing. Earlier […]
LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae
LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae. The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles. Optiflow Arterial cannulae have a “basket tip with […]