GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control software for general anesthesia delivery. The software is cleared for use with GE Healthcare’s Aisys CS2 anesthesia delivery system. The Chicago-based company initially released the technology in Europe in 2010 and is currently used in over 100 countries. Get the full […]
Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee. Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI). Get the full story on our sister site, Medical Tubing + Extrusion.
Avanos Medical today announced it entered into a definitive agreement to acquire OrthogenRx for $160 million. OrthogenRx makes viscosupplementation therapies to treat knee osteoarthritis pain, as well as commercial hyaluronic acid (HA) therapy products GenVisc 850 and TriVisc. Avanos will purchase the company for $130 million in cash at closing and an additional $30 million […]
Owen Mumford this week announced that it has started building its new production facility in Witney, Oxfordshire in the U.K. Owen Mumford’s new Witney facility will stand as a production site for the company’s recently launched, next-generation auto-injector Aidaptus. The company has decades of experience creating its own drug delivery, blood sampling and rapid diagnostic products […]
BreatheSuite today announced that it has received FDA 510(k) clearance for its BreatheSuite metered-dose inhaler (MDI) V1 device. BreatheSuite designed the device to turn existing MDIs into smart inhalers by automatically monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD. It has a disposable, battery-powered, portable MDI add-on and […]
Insulet (NSDQ:PODD) posted second-quarter results this week that beat the revenue consensus on Wall Street but missed on earnings estimates. The Acton, Mass.-based company reported losses of -$25 million, or -37¢ per share, on sales of $263.2 million for the three months ended June 30 for a sales growth of 16.31% compared with Q2 2020. Earnings […]
Medtronic (NYSE:MDT) today announced that it has launched its Prevail drug-coated balloon catheter in Europe. The medtech giant designed the Prevail catheter for percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. Get the full story on our sister site, Medical Tubing + Extrusion.
Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]
By Ronald Boumans, Emergo Group UDEM Adriatic d.o.o., based in Zagreb, Croatia, is a new name in the EU Notified Body community. They have been officially listed in the European database for Notified Bodies, NANDO, designated for the upcoming Medical Devices Regulation (EU) 2017/745 (MDR). Their Notified Body number is 2696. UDEM is not listed […]
By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]