Medtronic (NYSE:MDT) had much to tout with its pipeline as it released Street-beating fourth-quarter results. CEO Geoff Martha announced to analysts that FDA has granted the company’s much-anticipated Hugo robot an investigational device exemption approval. Medtronic is preparing to commence its Expand Uro trial in the U.S. to study Hugo in urologic procedures, Martha said […]
Drug-Device Combinations
Phillips-Medisize unveils Aria smart autoinjector
Phillips-Medisize today unveiled the Aria smart autoinjector platform designed to elevate patient care and reduce environmental impact. Hudson, Wis.–based Phillips-Medisize, a Molex company, said in a news release that the Aria platform introduces a small, simple smart injection device with a reusable electronic drive unit and single-use, disposable cassettes. Get the full story at our […]
Medtronic wins CE mark for smart insulin pen, Guardian 4 sensor
Medtronic (NYSE:MDT) announced today that it received CE mark approvals for its InPen smart insulin pen and its Guardian 4 sensor. Fridley, Minn.–based Medtronic’s new European approvals cover expanded functionality of the InPen for multiple daily injections (MDI), along with approval for the Guardian 4 sensor that requires no fingersticks for calibration or diabetes treatment decisions, […]
Avalyn Pharma touts study of aerosolized pulmonary fibrosis treatment
Avalyn Pharma announced today that it observed statistically significant success in a study of its aerosolized pulmonary fibrosis treatment. Seattle-based Avalyn presented data from a 24-week Phase 1/2 clinical study at the ISAM conference in Boise, Idaho. The data covered two dose regimens of AP01, a formulation of pirfenidone optimized for delivery through inhalation in patients […]
How Fractyl Labs is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections
Fractyl Labs CEO Harith Rajagopalan envisions a scenario in which those with type 2 diabetes don’t have to rely on insulin injections. Insulin has long been a staple of treatment for type 2 diabetes patients who need to manage their blood sugar levels, but Rajagopalan’s aim is to go beyond that temporary fix. Trained as […]
Giiant Pharma raises $11M for drug delivery platform for gastroenterology
Giiant Pharma announced today that it closed a $11 million seed financing round for its drug delivery technology platform. Montreal-based Giiant develops the Precision Delivery technology platform, which originated from the work of former Merck Frosst scientists, according to a news release. The company designs gut-restricted, tissue-specific, small-molecule drug therapeutics to be delivered through the platform. […]
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Propel […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery, according to […]
Navidea receives patent for dextran-based drug delivery vehicles
Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it received a patent for its dextran-based drug delivery vehicles. The U.S. Patent and Trademark Office (USPTO) issued U.S. patent 11,007,272 entitled “Compounds and Methods for Diagnosis and Treatment of Viral Infections,” with protection to October 7, 2037, according to a news release. Get the full story at our sister […]
BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing
BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain. The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release. Get the full story at our sister site, Drug […]
5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]