CeQur announced today that it picked up two recent FDA clearances for its Simplicity mealtime insulin patch pump system. The FDA cleared Simplicity for an extended wear time of up to seven days and gave the green light to a new 1-unit (1U) device. Additionally, Horw, Switzerland-based CeQur plans to share two clinical posters at […]
Food & Drug Administration (FDA)
MannKind wins FDA approval for inhaled insulin for children with type 1, type 2 diabetes
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for its Afrezza inhaled insulin powder for children. FDA approval covers use in children and adolescents aged 6 and older with type 1 and type 2 diabetes. Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler […]
Glucotrack CEO explains tech behind long-term CBGM implant
Glucotrack (Nasdaq:GCTK) has made great strides over the past several years as it advances its implantable continuous blood glucose monitor (CBGM). Rutherford, New Jersey-based Glucotrack’s device features no on-body external component. The company aims to offer it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that […]
Insulet initiates another Omnipod 5 recall affecting 7 million devices including some Dash, Eros systems
Insulet (Nasdaq:PODD) today announced a voluntary medical device correction for specific lots of its Omnipod 5, Dash and Eros pods. The company identified a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery with the affected current-generation Omnipod 5, previous-generation Omnipod Dash or the prior Omnipod Insulin Management System (Eros). Insulet said […]
Beta Bionics earmarks Q2 2027 for Mint patch pump launch, shares details on new tech
Beta Bionics (Nasdaq:BBNX) today provided an update on its expected commercialization timeline for its Mint patch pump system. Irvine, California-based Beta Bionics said it expects to fully commercialize Mint by the end of the second quarter of 2027. This represents an accelerated timeline compared to previous expectations for the end of 2027. The automated insulin […]
Glooko wins FDA clearance for cloud-based insulin dosing platform
Glooko announced today that the FDA granted 510(k) clearance for its EndoTool IV Cloud, a cloud-based, patient-specific insulin dosing platform. Palo Alto, California-based Glooko describes the EndoTool IV Cloud as the first FDA-cleared platform of its kind. The cloud-based version of EndoTool IV, it offers a clinical decision support solution for intravenous insulin dosing in […]
Tandem to submit tubeless pump to FDA with Street-beating Q1 on record pump shipments
Tandem Diabetes Care (Nasdaq:TNDM) today shared its plans to submit a tubeless insulin pump to the FDA. On the company’s first-quarter earnings call, President and CEO John Sheridan outlined the plans for Mobi Tubeless, the company’s existing Mobi pump that utilizes a novel infusion set option for tubeless insulin delivery. Currently, Insulet offers the leading […]
Glucotrack submits long-term implantable CBGM for FDA IDE
Glucotrack (Nasdaq:GCTK) announced today that it submitted its implantable continuous blood glucose monitor (CBGM) for FDA IDE. FDA IDE (investigational device exemption) would enable the company to initiate a U.S. clinical study for the fully implantable technology. Rutherford, New Jersey-based Glucotrack’s device features no on-body external component. The company aims to offer it for three years of […]
FDA says Insulet Omnipod 5 recall is serious after 476 device reports, issue is potentially undetectable by user
The FDA says last month’s recall of Insulet (Nasdaq:PODD) Omnipod 5 insulin pump pods has been identified as its most serious type. According to the FDA, such a recall may cause serious injury or death with continued use. Insulet announced on March 12 that it initiated a voluntary medical device correction for specific lots of […]
Tandem wins FDA clearance for automated insulin delivery in pregnant women with type 1 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy. The FDA cleared the company’s Control-IQ AID technology for use in pregnancy complicated by type 1 diabetes mellitus. Control-IQ+ powers both of Tandem’s available t:slim X2 and Mobi AID systems. San Diego-based Tandem says t:slim X2 […]
