Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Calypso anchored beacon transponder designed for use with its TruBeam, Edge and Clinac C-series medical linear accelerators. The Calypso system and the anchored beacon transponder are designed to detect tumor movement to aid in the delivery of lung stereotactic body radiotherapy with more precision, […]
Arthrosurface wins FDA nod for OVOMotion shoulder arthroplasty system
Arthrosurface said yesterday it won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system. The Franklin, Mass.-based company said the newly cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis. “This truly is a revolutionary stemless […]
Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor
Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims. The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said. “We strive to deliver real life […]
Innovus Pharma wins FDA nod for glucose monitoring kit
Innovus Pharmaceuticals (OTC:INNV) said today that its GlucoGorx glucose monitoring kit, which includes a glucose meter, test strips and a lancet device, won 510(k) approval from the FDA. The San Diego, Calif.-based company plans to launch its blood sugar monitoring kit in the second half of this year. Get the full story at our sister site, […]
FDA clears presbyopia treatment indications for Lensar’s Laser System
Lensar said today it won FDA 510(k) clearance for its Lensar Laser System with Streamline IV designed to create corneal pockets and flaps used in presbyopia treatments. With the new clearance, the Lensar Laser System is now indicated for use in procedures to implant presbyopic inlay devices, the Orlando, Fla.-based company said. The newly cleared […]
FDA requests more info for TearLab’s eye diagnostic tech
TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears. The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence. Get the […]
FDA clears Adherium’s inhaler sensor for OTC sales
The FDA gave Adherium (ASK:ADR) the go-ahead to launch over-the-counter sales of its Smartinhaler sensor for AstraZeneca‘s (NYSE:AZN) Symbicort asthma inhaler, the company touted last week. Adherium’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and date that a patient uses their inhaler and transmits […]
Materialise touts FDA first in clearance of 3D printed anatomical model tech
Materialise said today it won FDA 510(k) clearance for its Mimics inPrint software designed for 3D printing anatomical models for diagnostic use, touting it as the first clearance of its kind. The Belgian company said that last August, the FDA ruled that software designed to create files for 3D printing patient-specific anatomical models for diagnostic purposes […]
7 medtech stories we missed this week: March 23, 2018
From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]
MIS device startup Human Xtensions wins FDA nod for HandX device
Minimally invasive surgery device start up Human Xtensions said today it won FDA 510(k) clearance for its HandX device. The HandX device is a light-weight, handheld device designed to translate a surgeon’s natural hand motions into more complex movements inside the patient, the Israel-based company said. The device is part of a series of electromechanically-simplified […]
UroViu wins FDA nod for disposable diagnostic cytoscope
UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction. The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to […]
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