Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its PanoCam Pro Wide-field Imaging System designed for imaging newborn infants. The PanoCam Pro is a wireless imaging system deisgned to help detect external, anterior and posterior segment vision disorders in newborns, which the company says may have long term […]
510(k)
APN Health wins 510(k) for 3D cardiac mapping system
Electrophysiology tool developer APN Health said today it won FDA 510(k) clearance for its Navik 3D advanced cardiac mapping system. The system from Pleasanton, Calif.-based APN Health is designed to give operating electrophysiologists or cardiologists real-time 3D catheter locations using 2D fluoroscopic images correlated with the electrical activation of the heart to create 3D maps. “FDA […]
FDA: Average PMA time to decision hits record low
The FDA released a report today detailing its stats for pre-market approvals and 510(k) applications for 2015 and the 1st 3 months of 2016, hitting a high-water mark for its time-to-decision for PMAs. The FDA reported a significant improvement in the average decision time for PMAs, which cover high-risk Class III devices, clocking in at an average […]
FDA clears ScandiDos radiation dose monitor
Swedish dosimetry company ScandiDos said yesterday it won FDA 510(k) clearance for its Delta4 Discover device designed to verify radiation doses delivered to patients during radiation treatments. The Delta4 Discover is designed as an in-vivo dosimetry system which independently verifies all dosage delivery parameters with the aim of increasing the quality and overall safety of radiation-based […]
FDA clears Chemence’s Exofin tissue adhesive
Chemence Medical said yesterday it won FDA 510(k) for its Exofin topical skin adhesive designed for wound closure. The Alpharetta, Ga.-based company said it will offer the Exofin sealant in 2 sizes, and claimed the product is the “fastest polymerizing 2-octyl cyanoacrylate topical adhesive” available, with the highest viscosity formulation. “After spending more than 2 years […]
Zimmer Biomet wins 510(k) for Unite3D
Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Unite3D bridge fixation system designed for foot and ankle joint fusion surgery, as an alternative to traditional plates, screws and staples. The Warsaw, Ind.-based company said the Unite3D system is manufactured using 3D-printing technology, and features proprietary OsseoTi porous metal technology that mimics cancellous […]
TransEnterix finalizes response to FDA over 510(k) for SurgiBot
TransEnterix (NYSE:TRXC) said today it finalized its response to the FDA in relation to the 510(k) application for its SurgiBot system. Research Triangle Park, N.C.-based TransEnterix says the SurgiBot is the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside and operate through a single port. “We are pleased to have […]
BD wins FDA nod for HIV/AIDS diagnostic
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its FACSPresto system and CD4/Hb cartridge designed as an HIV/AIDS diagnostic. The Franklin Lakes, N.J.-based company’s system is designed as an automated multicolor fluorescent imaging cytometer and absorbance spectrometer, providing absolute and percentage results of CD4 T lymphocyte and hemoglobin concentration in blood […]
Philips wins 510(k) for MR suite patient monitor system
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its Expression MR400 monitor designed for patients undergoing magnetic resonance imaging. The MR400 is designed to provide ICU-comparable bedside monitoring for all patients, including those with serious medical conditions or those who require anesthesia, in the MR Suite. “When a patient is under anesthesia, […]
LifeWatch wins FDA nod for vital sign monitoring
Swiss remote diagnostic monitoring company LifeWatch said today it received FDA 510(k) clearance for its Vital Signs monitoring service. The service operates using wireless, patch-based vital signs monitors to allow for early detection of vital signs to enable more timely interventions, which the company claims leads to increased nursing efficiency and higher patient satisfaction. “This […]
CorMatrix wins FDA nod for Tyke neonate cardiac tissue
CorMatrix Cardiovascular said today it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants. The patch is designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing. The Tyke is derived from the company’s ECM technology platform and is composed […]