Bigfoot Biomedical touted data last week at this year’s Diabetes Technology Meeting showing that results from a feasibility study evaluating the company’s automated insulin delivery system closely matched data gleaned from prospective modeling. The company said it conducted extensive modeling to refine the technology’s algorithms prior to the start of its trial in 2016, Bigfoot said. […]
Drug-Device Combinations
Rivanna tackles epidural failure rates with its hand-held imaging device
When they were students in the biomedical engineering department at the University of Virginia, Will Mauldin and Kevin Owen found a problem that needed solving – anesthesiologists often fail to successfully place an epidural on their first try. It’s a problem that costs the medical system more than $1.5 billion each year, according to Rivanna Medical. […]
Insulet to offer $300m in senior convertible notes as part of private placement
Insulet (NSDQ:PODD) said today that it plans to offer $300 million in convertible senior notes due in 2024 as part of a private placement. The Billerica, Mass.-based company is also slated to give initial purchasers an option to buy an additional $45 million in notes. Get the full story at our sister site, Drug Delivery Business […]
Takeda, Portal Instruments ink $100m deal to combine biologics and needle-free drug delivery
Takeda Pharmaceutical (TYO:4502) and Portal Instruments said today that the pair inked a collaboration to develop and commercialize Portal’s needle-free drug delivery device with Takeda’s biologic medicines. The first development program is slated to combine Takeda’s monoclonal antibody for adults with moderately- to severely-active ulcerative colitis or Crohn’s disease with Portal’s technology. The investigational therapy is currently administered […]
Boston Scientific recalls certain sizes of Eluvia, Innova stents
Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a documentfiled by the Federal Institute for Drugs and Medical Devices in Germany. The company said it was pulling these particular devices due to the number of complaints that […]
One Drop launches its diabetes tech in Canada after regulatory nod
One Drop announced today that its Bluetooth-enabled blood glucose monitoring system and mobile app are now available throughout Canada after landing approval from the country’s regulatory agency. The company’s portfolio of diabetes management technology is now available in the U.S., Canada, the E.U. and the United Kingdom. Get the full story at our sister site, Drug […]
FDA conducts pre-approval inspection for Intersect ENT’s Menlo Park facility
Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant. Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 […]
West Pharma reveals new wearable SmartDose injectors
West Pharmaceutical Services (NYSE:WST) unveiled two new wearable injectors today from its SmartDose drug delivery platform as part of the annual PDA Universe of Pre-filled Syringes and Injection Devices meeting in Vienna, Austria. West’s first-gen SmartDose device is a user-loaded injector designed to deliver high volumes of viscous drug products. Get the full story at our […]
Mercator MedSystems to study its Bullfrog micro-infusion device in below-the-knee critical limb ischemia
Mercator MedSystems announced last week that it finished enrollment for a six-month trial of its Bullfrog micro-infusion device in patients with below-the-knee critical limb ischemia. The Emeryville, Calif.-based company’s 120-patient trial was designed to evaluate if Mercator’s Bullfrog device can improve blood flow and reduce the occurrence of restenosis following atherectomy-based revascularization. Mercator’s micro-infusion device delivers […]
Draper develops novel device to deliver drugs to the inner ear
Millions of people around the world are losing their hearing thanks to inner ear disorders and the pharmaceutical industry has spent years working to develop therapeutics to help address this patient population. But Jeff Borenstein, lead scientist for drug delivery at Draper, discovered by talking to experts in the hearing loss field that many of […]
Mylan misses sales, earnings estimate in Q3
Shares in Mylan (NSDQ:MYL) remained steady today after the pharmaceutical company missed expectations on Wall Street with its third quarter results. The Canonsburg, Penn.-based company posted profits of $88.3 million, or 16¢ per share, on sales of $2.99 billion for the 3 months ended Sept. 30, for bottom-line growth of 172% on sales loss of -2% compared with the […]