NinePoint Medical said today that it won FDA 510(k) clearance for the Intelligent Real-time Image Segmentation software upgrade for its flagship Nvision VLE imaging system. The newly cleared IRIS is an artificial intelligence-based platform for image feature segmentation, the Bedford, Mass.-based company said. The company touted that the approval was the first of its kind for […]
510(k)
StimWave wins FDA nod for Apple iOS-based WaveCrest mobile SCS patient controller
Stimwave said yesterday it won FDA 510(k) clearance for an Apple (NSDQ:AAPL) iOS device version of its WaveCrest Mobile platform patient controller application for pain management. The newly cleared system from the Pompano Beach, Fla.-based company allows patients with iPhone and Apple Watch devices to control WaveMaster multi-waveform automated programming for the company’s Wireless Freedom spinal […]
Masimo wins FDA nod for improved RD SET sensors
Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its RD SET sensors with measure-through motion and low perfusion SET pulse oximetry. The newly cleared sensors feature improved SpO2 accuracy specifications for patients under 3kg, the Irvine, Calif.-based company said, and are designed to improve accuracy, patient comfort and clinician workflows. “We’re delighted to be […]
Philips wins FDA nod for IntelliVue GuardianSoftware mobile app
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its IntelliVue GuardianSoftware mobile client application, designed to allow clinicians to view patient vital signs and receive early warning scores on mobile devices. The Amsterdam-based company said that the system is intended to move information that would normally be manually recorded in hospital medical-surgical units […]
FDA clears Viseon’s Voyant MIS spinal surgery tech
Early stage, spinal-focused medical device maker Viseon said today it won FDA 510(k) clearance for its minimally-invasive Voyant system intended for accessing, visualizing and illuminating spinal procedures. The Voyant system is composed of a sterile single-use, disposable retractor device featuring integrated visualization technology and a reusable controller for manipulation of the surgical site image. The […]
FDA clears Transseptal Solutions’ TP Crosser transseptal access device
Medtech developer Transseptal Solutions said yesterday it won FDA 510(k) clearance for its TSP Crosser transseptal access system. The Israel-based company said that the TSP Crosser is an advanced transseptal puncture system which features a built-in steering mechanism and is designed for use in accessing the left atrium. The system is intended for use during […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
Acessa Health wins FDA nod for 3rd-gen ProVu
Acessa Health said today it won FDA 510(k) clearance for its third-gen Acessa ProVu radiofrequency ablation system intended for use in treating symptomatic uterine fibroids. The Austin, Texas-based company said the newly cleared system features ultrasound visualization and a guidance mapping system, and that it is intended to provide a safe alternative to hysterectomy procedures for […]
FDA clears Xtreem Pulse’s PureFlow counter pulsation system
Preventive healthcare tech company Xtreem Pulse said today it won FDA 510(k) clearance for its PureFlow system designed to treat refractory chronic stable angina. The New York-based company said that the system was designed on a concept called external counter-pulsation, and was originally designed to improve unhealthy cardiovascular function. The company also claims the system […]
FDA launches pilot to shorten some 510(k) approval times
The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets. The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the […]
B-One Ortho wins FDA nod for total hip system
Early stage orthopedic tech company B-One Ortho said today it won FDA 510(k) clearance for the B-One total hip system, touting it as its first device clearance from the agency. The B-One is a cementless total hip system which features coating technology and instrumentation intended to optimize patient fit for a modern patient demographic, the […]