Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. Get the full story on our […]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
Mercator MedSystems raises $14m
Mercator MedSystems said last week that it raised $14.3 million from 25 investors as part of a $15 million equity round. The California-based company is developing catheter-guided micro-infusion systems for non-systemic delivery of therapeutic agents across blood vessels as a treatment for peripheral artery disease. Get the full story at our sister site, Drug Delivery Business […]
Dance Biopharm raises $21m for insulin delivery device
Dance Biopharm has raised $21 million from 283 investors as part of a $59.2 million offering, according to a document filed with the SEC this week. The privately-held California-based company’s Dance 501 device stores a liquid formulation of recombinant human insulin in a hand-held electronic inhaler. Using a vibrating mesh, the device produces particles of liquid insulin in a […]
Ivenix wins 510(k) clearance for infusion system
Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. Get the full story at our sister site, Drug Delivery Business News.
Medtronic, Tidepool ink deal for interoperable, automated insulin pump
Medtronic (NYSE:MDT) and nonprofit org Tidepool announced last week that the groups will work together to develop an interoperable, automated insulin delivery system. The medtech giant reported that it plans to build a Bluetooth-enabled MiniMed pump that is compatible with Tidepool’s Loop app, an open-source app for automated insulin delivery. Get the full story at our sister site, […]
Could this agreement boost continuous glucose monitor use?
An international panel of patients, physicians and researchers has agreed upon evidence-based target glycemic ranges for people who use continuous glucose monitors (CGMs) to control their diabetes. Announced today at the American Diabetes Association (ADA) conference in San Francisco, the International Consensus on Time-in-Range (TIR) was based on data from large pre-CGM clinical trials, CGM […]
Dexcom, Companion Medical will share glucose, insulin data
DexCom (NSDQ:DXCM) and Companion Medical have announced a collaboration to enable a direct exchange of continuous glucose monitoring (CGM) data from Dexcom with insulin data from InPen into both companies’ software applications. Companion made a partnership deal with Glooko this week to integrate data from its InPen smart insulin injection pen into Glooko’s diabetes data management system and mobile […]
Windtree, Eleison tout feasibility study results
Windtree Therapeutics (OTCQB:WINT) and Eleison Pharmaceuticals have announced positive results of a feasibility study using Windtree’s aerosol delivery system (ADS) to deliver Eleison’s inhaled lipid cisplatin (ILC) for lung cancer. In the study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in a phase 2 […]
Plaintiffs appeal Ocular Therapeutix win in shareholder lawsuit
Ocular Therapeutix (NSDQ:OCUL) is facing a revived class-action lawsuit lodged by investors after its share price took a hit after it revealed problems with its Dextenza device. The lawsuit, filed in the U.S. District Court for Massachusetts in November 2017, alleged that the Bedford, Mass.-based company misled shareholders about problems found by FDA inspections in 2017 that sent […]
Enable Injections inks deal with Sanofi for drug delivery platform
Enable Injections said today that it inked a partnership with Sanofi for its enFuse drug delivery platform. Cincinnati-based Enable Injections developed the enFuse device to enable patient-administered subcutaneous delivery of high-volume therapeutics outside of the hospital. The on-body drug delivery platform has a self-contained drug transfer system that is compatible with standard syringes and vial […]
- 1
- 2
- 3
- …
- 169
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube