Biocorp said this week that it received CE Mark approval for its Mallya device. The Mallya device is a smart sensor that turns insulin pens into connected devices. It records treatment information and sends the data to a smartphone application that allows for an automatic recording of doses to manage diabetes treatment. The France-based company […]
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here […]
T1D Exchange, DreaMed Diabetes partnered for insulin treatment plans
T1D Exchange and DreaMed Diabetes recently announced that it has entered a partnership to provide six clinics in its Quality Improvement Collaborative with DreaMed Advisor Pro to improve insulin treatment plans. The Quality Improvement Collaborative (QIC) is a data platform of 30,000 people with learning collaborative in 11 diabetes centers in the U.S. that are […]
Human factors and usability investment considerations for medtech companies
By Mark Tavano, Emergo Group Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
Chinese authorities update regulatory guidelines
By Stewart Eisenhart, Emergo Group China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com […]
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 […]
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 […]
Kurve Technology wins DoD contract for drug delivery tech
Kurve Technology won a U.S. Defense Dept. contract to test a new formulation for combating traumatic brain injuries. The Mill Creek, Wash.-based company makes a controlled particle dispersion device designed to deliver liquid drugs through a controlled, turbulent flow, according to the company’s website. Its ViaNase electronic atomizer can deliver most drug compounds through the […]
SkinJect raises $3m for skin cancer treatment patch
SkinJect said it raised nearly $3 million for the patch it’s developing to treat skin cancers. The $2.5 million equity round, revealed yesterday in a regulatory filing, involved 13 unnamed investors, Pittsburgh-based SkinJect said. The company is working on a thumb-sized device that features a dissolvable microneedle array to deliver drugs directly to top layers of […]
Philips touts Stellarex drug-coated balloon data
Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. […]