Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Data from the In.Pact Global study showed a 83.3% rate of freedom from clinically-driven target […]
Drug-Device Combinations
US DHS warns of vulnerabilities in Smiths Medical Medfusion 4000 infusion pump
The US Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team has released a warning over issues with Smiths Medical’s Medfusion 4000 wireless syringe infusion pump after discovering 8 cybersecurity vulnerabilities in the device. The notice is for versions 1.1, 1.5 and 1.6 Medfusion 4000 wireless syringe infusion pumps, according to the DHS […]
Ascensia Diabetes Care partners for mobile insulin management app
Ascensia Diabetes Care and Quattro Folia said today that the companies are partnering to combine Ascensia’s Contour Next One blood glucose monitoring system and Quattro Folia’s Balansio mobile insulin management app. According to the deal, the Contour Next One meter will connect via Bluetooth to the Balansio mobile app and deliver blood glucose readings to […]
Report: Abbott still looking to pull Xience DES from Indian market
Abbott (NYSE:ABT) is still looking to pull its Xience Alpine drug-eluting stent from the Indian marketplace after the country’s regulatory body set significant price caps on stents earlier this year, according to an Indian Economic Times report. The company reportedly approached India’s National Pharmaceutical Pricing Authority looking to withdraw the Xience stent yet again due to caps, along […]
Theraclion PI details breast cancer immunotherapy, ultrasound combo
The co-lead investigator for a metastatic breast cancer trial combining Theraclion‘s focused ultrasound technology and immunotherapy discussed the design and rationale of the study, the France-based company reported today. Dr. David Brenin, chief of breast surgery at the University of Virginia School of Medicine, said that although immuno-oncology has been gaining steam as a way to […]
Intersect ENT touts meta-analysis of steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) touted data today from a meta-analysis of two studies assessing the safety and efficacy of its investigational steroid-releasing sinus implant, Sinuva. The studies evaluated Sinuva in patients with recurrent and medically refractory nasal polyps. The meta-analysis, which was presented at the American Rhinologic Society’s annual meeting, included data from the Resolve and Resolve […]
Regeneron, Sanofi tout topline Ph3 data for injectable asthma drug
Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) touted data today from the pivotal Phase III trial of dupilumab in a group of patients with uncontrolled, persistent asthma. The drug is already approved for adults with certain forms of eczema. The two companies said they plan to seek FDA approval of dupilumab in asthma by the end of the year. […]
Medtronic recalls insulin infusion sets
Medtronic (NYSE:MDT) said today that it’s recalling some of the infusion sets used with its insulin pumps due to problems with a discontinued component. The Fridley, Minn.-based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall, Medtronic […]
Replicel prototypes its next-gen dermal injector
RepliCel Life Sciences (OTC:REPCF) said yesterday that it has developed prototypes of its RCI-02 motorized injection device designed with programmable depth and volume, as well as interchangeable needle head configurations. The injector was built to deliver an array of substances, including dermal fillers, drugs, cells or biologics intradermally, subcutaneously or intramuscularly. The company said it hopes […]
DarioHealth launches CGM mobile app for certain Android devices
Digital health company DarioHealth (NSDQ:DRIO) this week launched its Dario app in Google Play’s U.S. app store, making it available for certain Android devices. The mobile app accompanies DarioHealth’s blood glucose monitoring system, which connects via a headphone jack to turn a mobile device into a glucose monitor, according to the company. “We are very excited to […]