A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
Drug-Device Combinations
Dance Biopharm rebrands to Aerami Therapeutics
Dance Biopharm today said it rebranded as Aerami Therapeutics and will move its headquarters to Durham, N.C. The rebranding comes as the company seeks strategic partners for its Dance 501 inhaled human insulin. The company also hopes the rebranding will help progress into pivotal registration studies and expand to include inhaled therapeutics for endocrinology diseases. […]
Japan OKs OrbusNeich’s Combo Plus stent
OrbusNeich Medical today said it won market approval in Japan for its Combo Plus coronary stent. The Combo Plus stent is designed to address the risk of stent thrombosis associated with delayed healing in conventional drug-eluting stents. The Combo Plus DES uses endothelial progenitor cell capture technology and abluminal sirolimus drug elution delivered from a […]
Ocular Therapeutix doses first patients in pivotal allergic conjunctivitis trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) yesterday said it dosed the first patients in a Phase 3 clinical trial of its Dextenza drug-device combination. The U.S.-based Phase 3 clinical trial is a multi-center, 1:1 randomized, double-masked, placebo-controlled trial slated to enroll 80 patients. The study will evaluate Dextenza 0.4mg to treat allergic conjunctivitis and ocular itching versus a placebo […]
Valeritas touts h-Patch CBD study
Valeritas (NSDQ:VLRX) today announced positive results from its preclinical pharmacokinetic study of cannabidiol subcutaneous infusion. The study focused on delivering cannabidiol (CBD) through subcutaneous infusion through the company’s h-Patch Wearable Device. The results were presented at the CannMed Conference in Pasadena, Calif. Results from the study showed rapid and robust absorption and distribution of 40mg of […]
FDA clears Insulet’s OmniPod Dash as insulin pump alternative
Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump. The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and […]
Ambrosia app links Abbott’s FreeStyle Libre with Fitbit wearable
Ambrosia Systems said today that it launched its LinkBlueCon application on the Fitbit and Abbott (NYSE:ABT) FreeStyle Libre smartwatch platforms for glucose monitoring. San Fransisco-based Ambrosia’s LinkBlueCon app is designed to monitor glucose levels and receive notifications when glucose readings are outside the target range, all without the need to go to a clinic. Ambrosia said […]
Senzer Pharmaceuticals wins CE Mark for cannabinoid inhaler
Senzer Pharmaceuticals said yesterday that it has received the CE Mark for its cannabinoid inhaler. London-based Senzer said the Class IIa medical device approval, obtained in a joint project with manufacturing partner Europlaz, is the first-ever granted in the cannabinoid space and will allow the company to accelerate its plans to launch in the UK […]
Orchestra BioMed wins breakthrough nod for Virtue SEB
Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. The New Hope, Pa.-based […]
Eitan Group inks Canadian distribution deal for Sapphire infusion pumps
Eitan Group today announced it signed a distribution agreement with Canadian Hospital Specialities to distribute its Sapphire infusion pumps in Canada. Through the agreement, Canadian Hospital Specialties will supply and support Israel-based Eitan Group’s Sapphire infusion pumps to hospitals and alternate site customers in Canada. “CHS works to introduce the most advanced medical technology to […]
