Avanos Medical Inc. recalled 1,000 units of two of its Ballard Access suction systems for use in clearing artificial airways in neonatal and pediatric patients because of multiple complaints of cracked device manifolds. The recall affects 1,000 units distributed in the U.S. between October 2022 and January 2023, but this is the second recall of Avanos products in less than a year.
Two tough years have taken a toll on Medtronic plc with a warning letter for its diabetes unit, a reorganization that will spin off its respiratory, patient care and renal groups and layoffs of an undisclosed number of employees that began last week. The announcement late Friday of the U.S. FDA approval of the Minimed 780G insulin pump system could be a turning point for the company that brings it back into the competition for the growing diabetes market.
Biocartis Group NV recent entered an agreement with Apis Assay Technologies Ltd. to develop Apis’ breast cancer subtyping assay on its Idylla platform, is part of the Belgium company’s mission to bring complex molecular testing to as many patients as possible, outgoing Biocartis CEO Herman Verrelst, told BioWorld. The Idylla platform is a fully automated, real-time PCR based molecular testing system. With the technology failing to penetrate the U.S. market, and the share price tanking in recent years, the Belgium-based company recently appointed Roger Moody to the top job, effective Apr. 24, 2023.
Establishment Labs Holdings Inc. presented remarkably positive results at three years for its Motiva silicone breast implant at The Aesthetic Meeting 2023 in Miami on April 20. In keeping with the two-year results previously presented, the data demonstrated very low rates of device failure or contracture, which have plagued other implants. The strength of the investigational device exemption study makes an approval from the U.S. FDA ever more likely.
Following up on a bipartisan effort to keep down the costs of insulin, U.S. Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) reintroduced a bill on April 20 to ensure patients with diabetes can access the life-saving medicine without the excess costs associated with drug rebates and stymied competition.
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
The U.S. Senate Finance Committee has its work cut out for it as it crafts bipartisan legislation “that will take on the worst practices by drug-pricing middlemen and ensure that the prescription drug supply chain is pulling in the same direction: more competition and lower costs for patients and taxpayers,” committee Chair Ron Wyden (D-Ore.) said.
The success of the President’s Emergency Plan for AIDS Relief (PEPFAR) over the past 20 years is one of the biggest challenges in reaching its goal of eliminating HIV as a global public health threat by 2030, members of the U.S. Senate Foreign Relations Committee were told as they moved toward reauthorizing the program for another five years.
Rapidai Inc. received FDA 510(k) clearance for its Rapid NCCT Stroke technology, the latest tool in its portfolio of non-contrast-based solutions for shock and trauma care. The company claims it is the first and only medical device cleared by the agency to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.
Danco Laboratories LLC’s Mifeprex (mifepristone) and Genbiopro Inc.’s generic got another temporary reprieve April 19 from a court order that would tighten access to the abortion drug.
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