The FDA determined that another recall of BD Alaris infusion pumps is Class I, the most serious kind. In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices. BD’s […]
Drug-Device Combinations
Aptar wins FDA contract to study low global warning potential metered dose inhalers
Aptar Pharma announced today that it entered into a contract with the FDA to work on low global warming potential (low-GWP) inhalers. The FDA enlisted Aptar intends to study the challenges of developing low-GWP propellant metered dose inhalers (MDIs). The Crystal Lake, Illinois-based company expects its study to help define the potential target product profile […]
Baxter has a Novum IQ infusion pump warning
Correction: the original version of this article identified this as another recall for Novum IQ. Baxter issued a notification related to a Nov. 15 recall, not a notification for a separate recall. This story has been updated. Baxter (NYSE:BAX) issued an urgent medical device correction notice regarding its Novum IQ syringe infusion pump. A few […]
Eitan Medical’s Sapphire infusion pump recall is Class I
The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind. Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, […]
FDA warning doesn’t affect Embecta syringes, company says
Embecta (Nasdaq:EMBC) says an FDA safety communication regarding certain plastic syringes has no impact on its own products. The FDA yesterday warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese […]
Qnovia has positive results for inhaled smoking cessation therapy
Qnovia announced positive results from its first-in-human study for the QN-01 inhaled smoking cessation therapy. Richmond, Virginia-based Qnovia develops the RespiRx drug delivery platform that leverages a vibrating mesh nebulizer. CEO Brian Quigley explained the technology to Drug Delivery Business News last year. The company designed the QN-01 therapy to meet the need for safe and effective […]
1nhaler raises $2.5M for sustainable single-use inhaler
1nhaler announced today that it raised $2.5 million (£2 million) to develop a sustainable single-use dry powder inhaler. The Scotland-based drug delivery device developer cited limited inhalable medicine development due to a number of reasons. Those include accessibility, cost, performance and environmental impact. Its own development could enable the delivery of several dry powder drugs […]
ViCentra launches hybrid closed-loop insulin system with Dexcom G6
ViCentra announced today that it launched a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM. Utrecht, The Netherlands-based ViCentra designed the system to deliver insulin through its Kaleido insulin pump. The Diabeloop DBLG1 algorithm receives input from Dexcom’s G6 continuous glucose monitor. Together, they form an artificial pancreas offering flexible self […]
B. Braun infusion pump battery recall is Class I after one reported death
The FDA labeled a recall of B. Braun Medical infusion pump battery packs Class I, the most serious kind. B. Braun’s recall is a correction, not a product removal, affecting the battery pack for its Infusomat Space large-volume pump. It affects both wireless and non-wireless batteries, model numbers 8713051U and 8713052U. According to an FDA […]
Baxter recalls some syringe pumps due to underdosing risk
The FDA determined that the recall of the Baxter Novum IQ syringe pump is Class 1, the most serious kind. Baxter designed its Novum IQ syringe pump as an infusion pump to deliver fluids into a patient’s body in a controlled manner. The device is suitable for patient care in hospitals and outpatient facilities for […]
Surmodics has positive data on multiple drug-coated balloons
Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies. The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York. In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact Admiral DCB. The trial evaluated […]
