Ekso Bionics (Nasdaq:EKSO) announced today that it received FDA 510(k) clearance for its EksoNR robotic exoskeleton. Richmond, California–based Ekso Bionics designed the EksoNR technology for use with Multiple Sclerosis (MS) patients. According to a news release, EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, significantly expanding […]
Regulatory/Compliance
Si-Bone wins FDA clearance for expanded iFuse-TORQ implant indication
Si-Bone announced today that the FDA granted clearance for its iFuse-TORQ implant for pelvic fracture fixation. The regulatory nod expands Si-Bone’s iFuse-TORQ’s indication for acute, non-acute and non-traumatic pelvic fractures, including pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures. Santa Clara, California-based Si-Bone said in a news release that the […]
FDA clears Lensar Ally cataract treatment system
Lensar (Nasdaq:LNSR) announced today that it received FDA 510(k) clearance for its next-generation Ally system. Orlando, Florida–based Lensar designed the Ally adaptive cataract treatment system to enable cataract surgeons to complete the femtosecond-laser-assisted cataract (FLACS) procedure seamlessly in a single, sterile environment. According to a news release, the company intends to deliver the first Ally […]
ResMed finds a solution to semiconductor shortage, as well as some humor in it
ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now. President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on […]
FDA clears lumbar interbody fusion device from Zavation Medical
Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part of the Zavation eZspand interbody system, with precision and continual expansion to offer an optimized fit for each patient, allowing for the enhancement of structural stability and improved […]
Medicalgorithmics wins FDA nod for wearable ECG
Medicalgorithmics announced today that the FDA approved its Qpatch wearable device for electrocardiogram (ECG) readings. Warsaw, Poland–based Medicalgorithmics designed the state-of-the-art, wearable device to measure individual ECG signals and obtain accurate cardiac arrhythmia diagnoses across up to 15 days of monitoring sessions. According to a news release, Medicalgorithmics’ Qpatch has been selected for a clinical […]
AI-powered scope developer says new FDA clearance opens the door for telehematology
Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis. The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and […]
FDA designates new Medtronic HVAD pump implant recall as Class I
Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death. The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 […]
Abbott to develop biowearable for continuous monitoring of glucose, ketone levels
Abbott (NYSE:ABT) announced today that it is developing a new biowearable for continuously monitoring both glucose and ketone levels. The all-in-one sensor has already garnered FDA breakthrough device designation and will be used in pivotal trials in 2023, with regulatory submissions to follow thereafter. Get the full story at our sister site, Drug Delivery Business News.
Baxter warns of risks around Volara lung therapy at home
Baxter (NYSE:BAX) announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. The warning from Baxter for the Volara system — manufactured by Hillrom, which Baxter acquired for $12.5 billion last year — reinforces important safety information regarding a possible risk of the decrease in […]
Cardio Flow’s FreedomFlow guidewire wins FDA clearance
Cardio Flow this week won FDA 510(k) clearance for its FreedomFlow peripheral guidewire and announced the first commercial case using the device in the U.S. St. Paul, Minnesota-based Cardio Flow designed FreedomFlow to provide support for diagnostic and therapeutic devices in treating plaque blockages in arteries above and below the knee. It has a stainless […]
