An FDA warning over Medtronic’s (NYSE:MDT) diabetes business introduces uncertainty into new approvals, the company’s CEO said. Last month, Medtronic received an FDA warning letter highlighting inadequacies in specific medical device quality system requirements at its diabetes business’ Northridge, California, facility. Today at the 40th Annual J.P. Morgan Healthcare Conference, CEO Geoff Martha said there […]
Hugo, renal denervation and diabetes businesses to drive growth despite setbacks, Medtronic CEO says
Although three major pipelines at Medtronic (NYSE:MDT) have hit recent speed bumps, CEO Geoff Martha reiterated his belief that they will be major growth factors. In October, the medtech giant announced that the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension would continue into next year after lacking the positive results needed to end enrollment […]
FDA clears Glaukos’ iPrime
Glaukos (NYSE:GKOS) announced that it received FDA 510(k) clearance for its iPrime viscodelivery system. San Clemente, California-based Glaukos designed the iPrime viscodelivery system as a sterile, single-use, minimally invasive device for delivering viscoelastic fluid during ophthalmic surgery. Glaukos develops medical devices and pharmaceuticals centered around novel therapies for treating glaucoma, corneal disorders and retinal diseases. […]
Abbott CEO touts future of biowearables in first-ever healthcare company keynote at CES
Abbott (NYSE:ABT) Chairman & CEO Robert B. Ford highlighted what the future holds as he presented the first healthcare keynote ever at CES. Abbott Park, Illinois-based Abbott is designing biowearables based on its Freestyle Libre platform, with sensor technology designed to track key signals in the body like glucose, ketones and lactate, and could even one […]
Laborie acquires exclusive license for drug-coated baloon treatment for urethral strictures
Laborie Medical Technologies announced today that it acquired an exclusive license to the Optilume urethral drug-coated balloon (DCB). Portsmouth, New Hampshire-based Laborie purchased a perpetual, exclusive license to Optilume — developed by Urotronic — following FDA approval in December 2021. The DCB platform received CE mark approval for use in male anterior urethral strictures in […]
Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’
Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system. The company seeks a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy. The next-generation Eversense matched performance levels compared to the current […]
Glytec garners cybersecurity certification for insulin management system
Glytec announced today that its eGlycemic Management System received certified status for information security from HITRUST. Waltham, Massachusetts-based Glytec’s certification validates its platform’s ability to meet the highest standards for protecting sensitive data and information when working with its health system customers. According to a news release, HITRUST CSF certified status means the eGlycemic Management […]
Xeris Biopharma enters agreement for $30M private placement
Xeris Biopharma (NSDQ:XERS) announced today that it entered into a securities purchase agreement in connection with a private placement. Chicago-based Xeris’ private placement with an affiliate of Armistice Capital, LLC, will provide aggregate gross proceeds totaling approximately $30 million. The company will issue Armistice more than 10.2 million shares of its common stock at a […]
Your favorite articles from Drug Delivery Business News in 2021
From continuous glucose monitors to insulin pens, plus needle-free injection devices and inhalers — here are the most popular articles on Drug Delivery Business News from 2021: Links to your favorite articles: Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’ Eli Lilly partners with four companies on insulin pen tech Scancell picks PharmaJet’s needle-free […]
Novo Nordisk completes acquisition of Dicerna Pharmaceuticals
Novo Nordisk (NYSE:NVO) announced today that its acquisition of Dicerna Pharmaceuticals (NSDQ:DRNA) has been completed. Completion of the acquisition, initially announced on Nov. 18, 2021, follows the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) in connected on with Novo Nordisk’s cash tender offer for Dicerna at 11:59 p.m. […]
