Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]
Medtronic launches workflow system to help wean patients off oral opioids
Medtronic (NYSE:MDT) said today that it launched its Control Workflow system in the U.S. for use with its SynchroMed II intrathecal drug-delivery system. The medtech titan is hoping that, combined with its pain pump, the workflow system can help physicians in weaning patients off oral opioids. In a retrospective claims analysis, Medtronic found that 51% of […]
Kala seeks FDA nod for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease. The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala […]
Valeritas shares fall despite Street-beating Q3 prelims
Shares in Valeritas (NSDQ:VLRX) fell today after the medical technology company announced its preliminary financial results for the third quarter of 2018. The Bridgewater, N.J.-based company said it expects to post quarterly revenue of approximately $6.9 million, just ahead of the $6.85 million predicted by analysts. Compared to the same period in 2017, Valeritas’ sales are up […]
Tandem wins approval for insulin pump in Canada
Tandem Diabetes Care (NSDQ:TNDM) won a medical device license from Health Canada last week for its t:slim X2 insulin pump. The device integrates directly with Dexcom‘s (NSDQ:DXCM) G5 continuous glucose monitor and is the only system of its kind approved in Canada, according to the San Diego, Calif.-based company. Get the full story at our sister site, […]
Gerresheimer revenues up 6.7% in Q3
Gerresheimer AG’s revenue grew 6.7% year-over-year during its third quarter — with adjusted earnings up 2% — as medical plastic systems continued to be a revenue growth driver, especially due to the company’s U.S. inhaler project. Revenues for the quarter ended Aug. 31 were 353.7 million euros (equivalent to $399.7 million), up from 331.5 million euros ($374.6 […]
Canada clears Medtronic’s MiniMed 670G insulin pump
Medtronic‘s (NYSE:MDT) Canada subsidiary said today that it won a license from Health Canada for its MiniMed 670G insulin pump system. The insulin pump system is the first device in Canada that stabilizes glucose levels by automatically adjusting basal insulin delivery according to a user’s real-time needs, the medtech titan touted. Get the full story […]
FDA releases BD lock flush syringe facility warning letter
The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes. The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August […]
Concept Medical raises $60m for sirolimus-coated balloon IDE trial
Medtech developer Concept Medical said yesterday it received $60 million from cardiologist and serial entrepreneur Dr. Kiran Patel to support pursuit of an FDA investigational device exemption trial for its sirolimus-coated balloon device. The Florida-based company touted the device as the world’s first sirolimus-coated balloon, and said that funds will also be used to support […]
Philips’ HealthSuite will track Ypsomed’s connected self-medication devices
Philips and Ypsomed said today that they will jointly develop a solution for Ypsomed’s new self-medication adherence monitoring services based on Philips’ HealthSuite digital platform. The combination of Ypsomed’s connected devices and Philips’ (NYSE:PHG) cloud-based digital platform will allow Ypsomed’s pharmaceutical customers to deliver value-added services aimed at improving patient outcomes, the companies said in a joint statement. […]
Genentech kicks off Phase III trials for eye implant
Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched three Phase III trials evaluating the Port drug-delivery implant in patients with wet age-related macular degeneration and diabetic macular edema. The device is a refillable eye implant designed to continuously release drugs over a period of several months. Get the full story at our sister site, Drug […]
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