Eitan Group said today that it inked a deal with InfuSystem (NYSE:INFU) for repair services on its fleet of Sapphire infusion pumps. Madison Heights, Mich.-based InfuSystem plans to offer flat and al-la-carte options for Sapphire service and repair, citing a three-business-day turnaround goal on repairs. “Our partnership with Eitan Group will create savings and improve […]
Surmodics reaps $10m from Abbott on SurVeil balloon milestone
Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease. Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary […]
Enable Injections inks deal with Genentech
Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]
Study: No difference between Biotronik, Medtronic or Boston Scientific stents
A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Three-year results for some 3,393 […]
Insulet touts full market launch of mobile apps for Omnipod Dash
Insulet (NSDQ:PODD) touted the full market launch of the Omnipod Display and Omnipod View apps for people using the company’s Omnipod Dash system. The Display app enables users to display data from their Personal Diabetes Manager device onto their smartphones. The View app gives caregivers and family members the option to remotely monitor Omnipod Dash […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
Omnipod Dash sales drive Insulet Q2 results
Insulet (NSDQ:PODD) reported second-quarter results yesterday that missed the consensus forecast on Wall Street, but raised its outlook for the rest of the year. The Acton, Mass.-based diabetes tech company reported profits of $1.4 million or $0.02 per share, on sales of $177.1 million for the three months ended June 30, 2019, for a bottom-line […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
Bigfoot Biomedical inks deal with Pittsburgh health system
Bigfoot Biomedical today announced an agreement with Pittsburgh-based Allegheny Health Network (AHN) to further develop Bigfoot’s Unity investigational insulin delivery wireless platform. The diabetes startup described Unity as a first-in-kind, data-driven solution for optimizing insulin dosing and delivery. Bigfoot will work alongside AHN endocrinologists and primary care doctors to refine Unity’s clinical workflow features. “We understand […]
Acorda’s Parkinson’s device moves closer to E.U. approval
Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are […]
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