ICU Medical, Inc.

ICU Medical’s Smiths Medical division first began notifying healthcare providers of the separate issues in late May and early June. The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and tracheostomy tubes that enter the airway through the neck. The agency categorized each of them as Class I recalls, its most serious type.ICU Medical’s Smiths Medical division first began notifying healthcare providers of the separate issues in late May and early June and advised customers to stop using any of the affected devices.They include all models of the company’s Pneupac ParaPAC P300 and P310 ventilator kits, with about 27,000 total systems distributed worldwide, according to the FDA. The gas-powered ventilators are used in patient transports—such as during helicopter flights as well as between units within a hospital—and can also deliver support at the scene of an accident, including assistance in CPR.The FDA said it has received reports of one injury and one death linked to the possibility of the patient hose connector loosening or detaching during use, interrupting the flow of air. In its Sept. 20 letter seeking to get the word out to providers, the agency said to remove any ParaPAC ventilator from use if the outlet connector moves when inspected so that it can be repaired by Smiths Medical.The company also issued an urgent medical device correction for the same equipment earlier this year, notifying users that the tidal volume setting knob may move, potentially over- or under-delivering ventilation to the patient. Meanwhile, Smiths Medical’s Bivona Aire-Cuf neonatal, pediatric and adult tracheostomy tubes were recalled due to a manufacturing defect among specific lots, which may cause the securing flanges to tear off the sides of the tube. The FDA said Sept. 18 that it is aware of 35 reported injuries and two deaths.Separately, the agency issued Class I recall labels Sept. 11 to the company’s BLUperc, BLUgriggs and BLUselect tracheostomy kits—spanning about 850,000 units worldwide—over a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. The FDA has not listed any patient injuries in its recall notices.This past March, the FDA amplified a Class I recall covering more than 85,000 of Smiths Medical’s Medfusion syringe pumps, distributed in the U.S. across a period of more than 20 years, linked to software in need of updating.

Sandoz originally filed a complaint against United Therapeutics and its device partner in 2019. Sandoz and United Therapeutics’ yearslong dispute over a generic to pulmonary arterial hypertension med treprostinil has swung in Sandoz’s favor with a New Jersey district court deciding that the former Novartis subsidiary is owed damages from lost profits stemming from a 2015 breach of contract. The case stretches back to 2011, when Sandoz filed for FDA approval of its generic to United’s branded treprostinil drug-device combo Remodulin. United responded with a patent lawsuit, and the two settled in 2015, giving Sandoz permission to market its version in 2018. As per the agreement, United was not to take “any action directly or indirectly to prevent, delay, limit or otherwise restrict” Sandoz’s launch. But in 2015, United’s device supplier, Smiths Medical ASD, decided to discontinue production of its pumps but agreed to make more solely for United in 2016.Smith later alerted United that customers had been purchasing large quantities of the cartridges for other uses, prompting an agreement that required Smith to use “commercially reasonable efforts” to restrict cartridges sold to other parties. When Sandoz prepared to launch its generic, United and Smiths agreed that United could approve every Smiths cartridge sale to specialty pharmacies to ensure use for Remodulin only.Sandoz’s promotion partner RareGen (which now operates as Liquidia after a 2020 merger) managed to get its hands on more than 3,000 pumps for its launch but couldn’t secure the cartridges required for the product. After licensing talks with Smiths fell through, Sandoz and Liquidia found alternative cartridges to use with Smiths' pump, which were cleared for use by the FDA in 2021.Sandoz filed its initial complaint against United and Smiths in 2019, alleging restraint of trade and monopolization, among other related charges, and seeking damages for lost profits from the lack of necessary cartridges. Sandoz and Smiths have since settled over the course of the litigation, but United persisted. After a trial earlier this year, the U.S. District Court for the District of New Jersey has now agreed that Sandoz’s lost profits after its launch were a “natural and probable consequence” of United’s breach of its 2015 settlement promise to not restrict the generic’s launch, U.S. District Judge Brian Martinotti wrote in a recently unsealed Sept. 6 opinion. The damages Sandoz is owed for lost profits stand at $137 million, but a reduction “is warranted” due to the saved cost of Liquidia’s profit share. That reduction should be calculated between the parties who “shall consider the actual profits that were realized” in Sandoz’s intravenous-only launch, Martinotti noted. Liquidia and Sandoz will divide the proceeds from the litigation evenly, but Liquidia will not retain any of the net proceeds due to litigation finance agreements, Liquidia said in a statement. Meanwhile, United and Liquidia are battling in separate litigation over Liquidia’s proposed generic to United’s inhalation powder treprostinil, Tyvaso DPI. United sued the FDA in February over its approval process for Liquidia’s Yutrepia, then sued the generic manufacturer over a recently acquired patent. After a judge in Delaware removed an injunction that prevented the FDA from approving Yutrepia, the agency last month opted to hold off on a full approval until United’s market exclusivity runs out in May 2025. 

In collaboration with ATX Medical Solutions, SKT launches X Caliber in Australia, which has one of the highest rates of pet ownership in the world SKT also inked a commercial contract with MEDIVET Pet Hospital & Clinic to offer X Caliber in Indonesia. SEOUL, South Korea, May 28, 2024 /PRNewswire/ -- SK Telecom (NYSE:SKM, "SKT") today announced that it officially launched its AI-based veterinary X-ray image diagnosis assistance service 'X Caliber' in Australia. X Caliber is an innovative service that uses AI to analyze X-ray images of dogs/cats within around 15 seconds. Since X Caliber uses cloud to store and retrieve data, there is no need to install a separate server within the hospital. Veterinarians can examine the results of the AI-based image diagnosis on their mobile devices or PCs anywhere, anytime. The sensitivity of X Caliber stands at 86-94%: 94% for detection of 16 different abnormal patterns from abdominal X-ray images of dogs; 88% for detection of 10 different abnormal patterns from chest X-ray images of dogs; and 86% for detection of 7 different abnormalities from musculoskeletal X-ray images of dogs. Since entering a strategic partnership with ATX Medical Solutions ("ATX"), a leading provider of medical devices in Australia, in November 2023, SKT has been working closely with ATX to prepare for the commercial launch of the service by running beta tests. With today's official launch, X Caliber can be used by over 100 veterinary clinics in Australia. Australia is a pet-loving country with one of the world's highest pet ownership rates. Over two thirds of households are estimated to own a pet, with the total number of pets standing at around 29 million as of January 2024. The average number of pets per household in Australia is 1.3 dogs and 1.6 cats. SKT and ATX will also be attending the Australian Veterinary Association (AVA) Conference 2024, one of the largest gatherings of veterinary professionals in Australia, in Melbourne from May 27-31, to introduce X Caliber to veterinarians. Moreover, SKT announced that it signed a commercial contract with MEDIVET Pet Hospital & Clinic, Indonesia's largest premium veterinary hospital chain, to provide X Caliber to MEDIVET's hospital. The company sees this deal as a good opportunity to introduce X Caliber not only to Indonesia, but also to the rest of the Southeast Asian market. Meanwhile, SKT is currently actively providing beta service to veterinary clinics in North America, Europe, and Asia to further expand X Caliber's presence in the global market. About SK Telecom SK Telecom has been leading the growth of the mobile industry since 1984. Now, it is taking customer experience to new heights by extending beyond connectivity. By placing AI at the core of its business, SK Telecom is rapidly transforming into an AI company with a strong global presence. It is focusing on driving innovations in areas of AI Infrastructure, AI Transformation (AIX) and AI Service to deliver greater value for industry, society, and life. For more information, please visit our LinkedIn page . SOURCE SK Telecom