The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency. The FDA defines a combination product as one composed of any combination of a drug, device and/or a […]
Smiths Medical recalls Medfusion 4000 due to issue with software update
Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s […]
Medtronic adds AI-fueled Klue to its diabetes management lineup
Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation […]
Lilly to integrate DexCom CGMs in automated dosing system
Eli Lilly (NYSE:LLY) announced that it will integrate Dexcom (NSDQ:DXCM) products into its personalized diabetes management system, now under development. Under the new, non-exclusive agreement, Indianapolis-based Lilly will use San Diego-based Dexcom’s continuous glucose monitoring (CGM) devices in pen-based and pump-based platforms in Lily’s diabetes management system. The pen-based platform is designed to integrate personalized data from […]
Dexcom CEO apologizes for remote monitoring outage
Dexcom (NSDQ:DXCM) CEO Kevin Sayer publicly apologized on Friday for an outage over Thanksgiving weekend that cut off users’ ability to share glucose monitoring data with caregivers and loved ones. The Dexcom Follow app normally allows users of the company’s G6 continuous glucose monitor to share that data with up to 10 people, according to the […]
FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller
The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM) t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately […]
Medicina recalls IV Luer Slip syringes
Medicina is recalling its IV Luer Slip syringe due to incorrect packaging. According to the company, syringes were incorrectly packaged with a needle, which means they are not sterile and could cause a needle stick injury. The device affected by the recall is 3ml Luer Slip syringe without needle with Medicina product code IVS03, NHS […]
Eitan Group signs service agreement with Integrated Medical Systems
The Eitan Group this week said it signed a service partnership with integrated Medical Systems. Through the agreement, Integrated medical Systems will be the service provider for the Eitan Group’s Sapphire infusion pumps that are used in hospital-based and alternate site infusion. “For over two decades, IMS has worked to provide innovative solutions for alternate […]
Beta Bionics’ bionic pancreas wins breakthrough status from FDA
The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]
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