MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions. MedAlliance received its first IDE for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August. […]
FDA
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. The system speeds up dosing with an adaptive sensor and automated cassette activation feature. […]
EOFlow submits wearable, disposable insulin patch pump for FDA 510(k) clearance
EOFlow announced recently that it submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump. San Jose, California-based EOFlow submitted its application on Dec. 27, 2022. It aims to enter the U.S. diabetes market, expanding its reach outside Korea. The company said in a news release that over 600 people in […]
FDA accepts NDA for over-the-counter Narcan nasal spray from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray. The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray […]
FDA clears Dexcom G7 next-gen CGM
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system. FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2 years and older. San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6. It offers a 30-minute […]
FDA clears Mallya smart insulin pen device from Biocorp
Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical device that connects insulin pens. Mallya, a smart sensor, attaches directly to insulin pen injectors to make them connected devices. It automatically collects nad records key treatment information and transmits it to a dedicated digital application. That data includes selected […]
FDA says Insulet Omnipod Dash batteries recall is Class I
The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level. Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. The […]
Better Therapeutics submits FDA de novo request for type 2 diabetes treatment
Better Therapeutics (Nasdaq:BTTX) announced today that it submitted a de novo classification request to the FDA for its BT-001 technology. San Francisco-based Better Therapeutics seeks marketing authorization for the BT-001 prescription digital therapeutic (PDT). It potentially represents the first-in-class PDT using cognitive behavioral therapy (CBT) to treat type 2 diabetes. Marketing initially would cover type […]
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Medtronic, FDA warn on potential cybersecurity risk with MiniMed insulin pump
Medtronic (NYSE:MDT) issued an urgent medical device correction notice to warn of potential issues with some MiniMed automated insulin delivery systems. The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose […]
