By Kate Jablonski, Emergo Group The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Japan approves iSchemaView’s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, […]
Strata Skin Sciences inks Korea distribution deal
Strata Skin Sciences (NSDQ:SSKN) today announced a new Korean direct distribution deal with Kosmo Meditech for direct capital sales and direct recurring revenue sales in Korea. Kosmo Meditech has worked with Strata Skin Sciences for more than 13 years. The deal with help strengthen Strata’s Xtrac excimer laser value proposition in Korea and expand its installed […]
South Korean regulators establish new regulations for IVD devices
By Stewart Eisenhart, Emergo Group The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight of these devices’ safety and quality, according to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Kohlberg buys Nelipak
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 […]