Nelipak yesterday announced that private equity shop Kohlberg acquired the healthcare packaging company for an undisclosed amount. Cranston, R.I.-based Nelipak manufactures rigid healthcare packaging used in Class II and Class III medical devices and pharma drug-delivery products. The company also has in-house design, development, prototyping, manufacturing and quality teams to assist in the production of […]
Ocular Therapeutix launches Dextenza eye insert
Ocular Therapeutix (NSDQ:OCUL) yesterday announced the commercial launch of its Dextenza ophthalmic insert in the U.S. Dextenza is an ocular insert that is designed to release 0.4 mg of dexamethasone to relieve pain after ophthalmic surgery. It can deliver drugs for up to 30 days after treatment in a physician’s office. Get the full story on […]
South Korea trade group, Emergo partnered for medical device RA/QA support
By Stewart Eisenhart, Emergo Group The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association, has partnered with global regulatory consulting firm Emergo by UL to provide European market compliance support to the group’s more than 500 member companies. Get the full story here at the Emergo Group’s blog. The […]
FDA ends medical device Alternative Support Program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available in an effort to boost transparency and better monitor product safety. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
Critical Innovations receives breakthrough device designation for FOAM device
Critical Innovations received breakthrough device designation from the FDA for its Fast Onset Abdominal Management (FOAM) device. The device is designed to deliver quick-expanding foam to tamponade severe internal bleeding in trauma patients, according to the Inglewood, Calif.-based company. It controls severe bleeding in the abdomen when surgical intervention is not immediately available. Get the […]
Ever Pharma launches D-mine micro infusion pump for Parkinson’s
Ever Pharma today announced that it launched its D-mine portable micro infusion pump for Parkinson’s disease. The device recently received CE Mark approval in Europe and is now being rolled out in several European countries, according to the company. D-mine is designed to give users precise continuous subcutaneous drug delivery for Parkinson’s patients. Get the full […]
Vyaire Medical recalls 3m enFlow fluid warming cartridges
Vyaire Medical issued a Class I recall of nearly 3 million enFlow fluid warning system disposable cartridges after it discovered that patients could be exposed to unsafe levels of aluminum. The recall affects two of the Mettawa, Ill.-based company’s enFlow cartridges, including the 980200EU enFlow – Disposable Cartridge and the 980202EU enFlow – Disposable Cartridge […]
European Commission warns on supply disruptions due to MDR, IVDR
By Stewart Eisenhart, Emergo Group A new factsheet from the European Commission advises healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story […]
Boston Scientific adds 600 employees in Costa Rica
Boston Scientific (NYSE:BSX) is reportedly hiring 600 people at two of its Costa Rica facilities. The Marlborough, Mass.-based company plans to hire workers with different levels of educational backgrounds, including those with sixth-grade levels of schooling, professional engineering graduates, finance, accounting and other positions. Boston Scientific will hire employees for its La Aurora de Heredia and […]
Apple stores to sell One Drop glucose monitor
Apple (NSDQ:AAPL) is reportedly selling One Drop blood glucose monitors in a small number of its namesake stores in the U.S. One Drop is a compact blood glucose monitor that is compatible with the iOS Health app and the Apple Watch. The device is connected through Bluetooth and draws a small amount of blood to measure […]
Establishment Labs buys Costa Rica plant
Establishment Labs Holdings this week purchased a manufacturing facility in Alajuela, Costa Rica for an undisclosed amount. The company executed a deed with Zona Franca El Coyol to complete the purchase of Building 25 in the Coyol Free Zone in Alajuela, Costa Rica. The facility previously opened at the end of 2016 and the company […]