Bausch + Lomb said today that it won FDA 510(k) clearance for the use of Tangible Hydra-PEG contact lens coating on new devices, now cleared for use with lenses made from its Boston gas permeable materials. The new clearance will allow the Bridgewater, N.J.-based company to use the coating on its Boston XO, Boston XO2, […]
Becton Dickinson wins FDA 510(k) for Wavelinq 4F endoAVF system
Becton Dickinson (NYSE:BDX) said today that it won FDA 510(k) clearance for its WavelinQ 4 French endovascular arteriovenous fistula creation system. The Franklin Lakes, N.J.-based company said that the newly cleared WavelinQ 4F endoAVF system features improved technology that allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial […]
Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system
Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform. The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based […]
BD launches second-gen ergonomic injection pen
Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable subcutaneous injection depth, according to BD. Get the full story at our sister site, Drug Delivery Business News.
FDA clears Rebound Therapeutics’ minimally invasive neurosurgical endoscope
Rebound Therapeutics has secured FDA 510(k) clearance for its Aurora Surgiscope system, which it touts as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and illumination during neurosurgical procedures, the Irvine, Calif.–based company said yesterday. “Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any […]
Perspectum wins FDA nod for biliary duct mapping software
Perspectum Diagnostics said this week that it won 510(k) clearance from the FDA for its biliary visualization software, MRCP+. The company’s AI-powered software is designed to provide improved visualization, monitoring and reporting of intra-hepatic ducts. The metrics produced by MRCP+ could be particularly useful for doctors monitoring patients with primary sclerosing cholangitis, according to Perspectum […]
Additive Ortho wins FDA nod for 3D-printed customized foot & ankle implants
Additive Orthopaedics said yesterday that it won FDA 510(k) clearance for its patient specific 3D-printed locking lattice plates. The newly cleared devices from the Little Silver, N.J.-based company now have indications from the federal watchdog for the alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as those in the foot and […]
Ortho dev Ossio wins FDA nod for bio-integrative bone pins
Orthopedic device company Ossio said yesterday that it won FDA 510(k) clearance for its OssioFiber BonePin family of products. The Woburn, Mass.-based company said that products in the OssioFiber BonePin family feature a proprietary bio-integrative material that it claims provides stability and secures bone fixation during healing with no permanent hardware left behind. The company […]
CathWorks wins FDA 510(k) for FFRangio
Non-invasive fractional flow reserve tech developer CathWorks said yesterday that it won FDA 510(k) clearance for its FFRangio non-invasive fractional flow reserve analysis technology. The Israel-based company said that approval came based off of results from the FAST-FFR blinded comparative study study which showed that its FFRangio system was accurate when compared to invasive FFR. “The FDA […]
What you need to know about growing cyber threats to medtech
Medical devices are an especially rich cybersecurity target for malicious activity by those seeking commercial gain or just trying to wreak havoc. And while data theft is a serious threat, the risks posed by hacks that involve the expanding universe of networked medical devices can be especially menacing. Nach Davé and John Pappan, Premier Research […]
Medical device industry regulation is changing: What you need to know
The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants. Veteran regulatory […]
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