MediView XR announced today that it received FDA 510(k) clearance for its XR90 augmented reality-based visualization and navigation platform. The company designed the surgical platform for adjunctive use in minimally invasive ultrasound and CT-guided needle-based procedures. Cleveland-based MediView said in a news release that its uses include procedures for soft tissue and bone. “This is […]
510(k)
FDA clears ECG interpretation software from AccurKardia
AccurKardia announced today that the FDA granted 510(k) clearance for its cloud-based electrocardiogram (ECG) interpretation software. The AccurECG analysis system, a device-agnostic, fully automated platform, offers a wide range of benefits in ECG interpretation. It features beat-by-beat analysis, ventricular/supraventricular ectopic beat detection and heart rate measurement. The system offers automated interpretation of 13 different heart […]
Koru Medical submits infusion system for FDA 510(k) clearance
Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe. In January, Mahwah, New Jersey-based Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought […]
FDA clears non-invasive mechanical ventilator from Getinge
Getinge announced today that the FDA cleared its Servo-air Lite wall gas-independent, non-invasive mechanical ventilator. Gothenburg, Sweden-based Getinge designed the turbine-driven ventilator to offer ICU-quality ventilation. However, its non-invasive nature gears it more toward spontaneously breathing patients in need of extra breathing support. The ventilator features a powerful turbine and long-lasting battery backup power. Getinge […]
FDA clears Boston Scientific Embold Soft & Packing coils for embolization procedures
Boston Scientific announced that it received FDA 510(k) clearance for its Embold Soft & Packing coils. Marlborough, Massachusetts-based Boston Scientific designed the coils for use in a variety of embolization procedures. They aid in the minimally invasive treatment for blocking one or more blood vessels, obstructing or reducing blood flow. The procedure stops hemorrhaging, prevents […]
Invo wins FDA clearance for expanded InvoCell labeling
Invo Bioscience (Nasdaq:INVO) announced that the FDA granted 510(k) clearance to expand the labeling on its InvoCell device. Sarasota, Florida-based Invo’s InvoCell indication now includes a five-day incubation period. Data supporting this clearance demonstrated improved patient outcomes for the device, which previously had a three-day incubation period. The company designed InvoCell to allow fertilization and […]
FDA clears Pounce LP thrombectomy system from Surmodics
Surmodics (Nasdaq: SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system. News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from “Hold” to “Buy.” The analysts cited positive developments pointing toward the likely approval of Surmodics’ SurVeil platform sooner than previously thought. […]
FDA clears Apyx Medical’s Renuvion Micro Handpiece
Apyx Medical today announced it received FDA 510(k) clearance for its Renuvion Micro Handpiece. The Micro Handpiece is the latest addition to the company’s Renuvion product line. It is cleared with an indication for the delivery of radiofrequency (RF) energy or helium plasma where coagulation and contraction of soft tissue are needed, including subcutaneous tissue. […]
FDA clears OCD cap from Neuronetics
Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its obsessive-compulsive disorder MT cap. The FDA cleared the company’s OCD motor threshold (MT) cap technology for NeuroStar advanced therapy for mental health. According to a news release, determining a patient’s MT represents a critical step to establishing their prescription before starting treatment. NeuroStar, […]
NeuroOne submits RF ablation system for FDA 510(k) clearance
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it submitted an FDA 510(k) application for its OneRF ablation system. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the […]
iRhythm’s FDA warning letter details alleged violations and patient deaths
An FDA warning letter made public today accused iRhythm Technologies of violations of the Federal Food, Drug, and Cosmetic Act’s rules for labeling, quality systems and medical device reporting. In at least two cases, iRhythm did not report patient deaths in the required 30-day window, and instead reported them the following year, the FDA said. […]
