Valeritas (NSDQ:VLRX) said today that its V-Go wearable insulin delivery system is available in Puerto Rico. The Bridgewater, N.J.-based company has partnered with Fusion Consulting group to promote V-Go to Puerto Rico-based endocrinologists and general practitioners with Type II diabetes patients. Get the full story at our sister site, Drug Delivery Business News.
Drug-Device Combinations
FDA’s Gottlieb updates on IV bag shortages after Hurricane Maria
FDA commissioner Dr. Scott Gottlieb expects that the shortage of IV fluids caused by Hurricane Maria in Puerto Rico will improve in the coming weeks and months, according to a statement issued by the agency yesterday. The regulatory chief said that the FDA is working with manufacturers like Baxter (NYSE:BAX) and B. Braun to import products from foreign facilities into the […]
WaveForm touts clinical trial data for continuous glucose monitor
WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer coating […]
Voluntis, WellDoc partner to offer digital diabetes management system
Voluntis has inked a commercial deal to combine its insulin titration tech with WellDoc‘s coaching platform to create a digital management solution for people with Type II diabetes. Cambridge, Mass.-based Voluntis has developed an FDA-approved system, Insulia, which provides automated insulin dose recommendations that can be monitored remotely by a patient’s healthcare team. WellDoc’s BlueStar program gives […]
Tandem Diabetes registers $40m offering
Tandem Diabetes Care (NSDQ:TNDM) has registered for a $40 million offering of its common stock, according to an SEC filing posted today. Shareholders for the San Deigo, Calif.-based company approved a proposal last year to effect a 1-for-10 reverse stock split that they believed would help make Tandem’s stock more attractive to institutional investors. Get the full story at our […]
Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity. The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy. Get the full story at our sister site, Drug […]
Cordis, Medinol tout first commercial implants of Elunir drug-eluting stent in U.S.
Cordis and Medinol announced today that the first commercial uses of the Elunir drug-eluting stent in the U.S. were performed at New York-Presbyterian Hospital/Columbia University Medical Center and the Piedmont Heart Institute in Atlanta. The Elunir stent, developed by Medinol and distributed by Cordis, features a metallic spring tip and the narrowest strut width of any stent on […]
Braeburn raises $110m for opioid use disorder depot injection
Braeburn Pharmaceuticals has raised $110 million in a mezzanine round of financing led by Wellington Capital. Other investors included Avista Capital Partners, RA Capital Management, Deerfield Management and Apple Tree Partners. The Princeton, N.J.-based company said it plans to use the new funds to support the FDA approval process and commercialization of CAM2038, a weekly and […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s (NYSE:MDT) Resolute […]
Eyenovia sets range for IPO
N.Y.-based startup Eyenovia updated its regulatory filings to reveal that it plans to offer 2.73 million shares priced between $10 – $12 apiece in its initial public offering. The 7-person company, which is developing a device to deliver small doses of drugs to the eye, is applying to list on the Nasdaq exchange under the symbol, “EYEN”. Get the […]
Glaukos touts Ph2 glaucoma trial for drug-eluting implant
Glaukos (NYSE:GKOS) touted data today from a Phase II trial of its travoprost intraocular implant in a 12-month cohort of glaucoma patients. The company’s iDose device is placed during a micro-invasive procedure and filled with a special formulation of travoprost – a drug used to reduce intraocular pressure. The implant continuously delivers therapeutic levels of travoprost […]