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 to buy OrthogenRx for $160M
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 starts work on new production center in U.K.
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 […]
FDA clears BreatheSuite’s device to turn regular metered-dose inhalers into smart inhalers
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 slides on mixed-bag Q2 results
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 launches Prevail drug-coated balloon catheter in Europe
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 initiates coronary drug-coated balloon study in U.S.
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 […]
New Croatian notified body designated to European MDR
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 […]
Ensuring safe and effective distribution of COVID-19 vaccines
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 […]
Clinical study sponsors may become non-EU post-Brexit
By Ronald Boumans, Emergo Group The departure of the United Kingdom from the European Union on January 1, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and […]
