Pursuit Vascular (Maple Grove, Minn.) today announced that it has won FDA clearance for a broader indication of its ClearGuard HD antimicrobial caps. The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous […]
510(k)
BrainCool wins FDA nod for IQool Warm temp regulation system
European medical device developer BrainCool said today it won FDA 510(k) clearance for its IQool Warm System with indications for thermal regulation to cool and rewarm adult patients. The Swedish company said the newly cleared next-gen temperature regulation system is designed for temperature management with a focus on the head and neck, thighs and torso. The system […]
Lumendi wins FDA nod for DiLumen IS endoscopic scissors
Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures. The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen […]
7 medtech stories we missed this week: May 25, 2018
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
Avinger wins FDA nod for next-gen Pantheris
Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease. Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability […]
FDA clears Zimmer Biomet’s 3D-printed titanium Zyston spinal implant
Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Zyston Strut open titanium interbody spacer system, touting it as the company’s first 3D-printed titanium spinal implant. The Zyston Strut open titanium system is a family of lumbar cages intended to enhance strength, graft capacity and visualization capabilities of interbody spacers in spinal fusion […]
Inari Medical wins FDA 510(k) for FlowTriever
Inari Medical said today it won FDA 510(k) clearance for its FlowTriever stent retriever designed to treat pulmonary embolisms. The clearance came based upon results from the company’s Flare clinical study of the device, which examined data from 106 patients with acute pulmonary embolisms treated with the FlowTriever at 18 US sites, the Irvine, Calif.-based company […]
J&J’s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device. The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications. Approval of the device came […]
Report: FDA exempts surgical facemasks from 510(k) requirements
The FDA finalized a rule this week exempting specific disposable respiratory protective masks from 510(k) requirements, according to a Regulatory Affairs Professionals Society report. The move was adopted in hopes of reducing regulatory burden on manufacturers of the surgical apparel devices and to eliminate the costs associated with regulatory clearance, according to the report. With […]
FDA clears Additive Ortho’s patient specific 3D printed bone segments
Additive Orthopaedics said yesterday it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments. The 3D-printed segments are designed to address internal bone fixation in the ankle and foot, the Little Silver, N.J.-based company said. “This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants. In cases […]
FDA clears MC10’s BioStamp nPoint wearable sensor
Wearable sensor developer MC10 said yesterday it won FDA 510(k) clearance for its BioStamp nPoint wireless biometric data collection platform. The newly cleared system is designed for the continuous collection of physiological data in either home or traditional healthcare settings, the Lexington, Mass.-based company said. The system succeeds the company’s previous BioStampRC sensor. MC10 said that the […]