Tidepool said this week that it raised $6 million from JDRF and the Leona M. & Harry B. Helmsley Charitable Trust to support the development of Tidepool Loop – a hybrid, closed-loop automated insulin delivery app. Tidepool, a non-profit diabetes data management group, is working to create an FDA-regulated app that is compatible with multiple insulin […]
Abiomed puts $15m into Shockwave
Abiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies. Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The […]
FDA advisory panel to mull transvaginal mesh
The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse. According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the […]
Del. supremes uphold Fresenius bailout on Akorn buy
Delaware’s Supreme Court ruled last week to uphold a decision by the state’s Chancery Court that Fresenius (ETR:FRE) could walk away from its $4 billion merger with Akorn (NSDQ:AKRX). The initial deal was designed to help Fresenius move into new therapeutic areas and dosage forms, including eye drugs, ear drops, nasal sprays and respiratory drugs. But Fresenius abandoned the purchase in […]
How Reggie Groves reinvented Medtronic’s atrial fibrillation biz
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview: When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much […]
Impel NeuroPharma raises $68m for CNS drug-device tech
Impel NeuroPharma said today that it raised $67.5 million in a Series D financing round, with investments from KKR, Norwest Venture Partners, Vivo Capital, 5Am Ventures and venBio Partners. The Seattle-based company plans to use the round’s proceeds to support clinical development efforts for its intranasal drug-delivery device technology. Get the full story at our sister site, […]
Novocure touts analysis of pivotal glioblastoma trial results
Novocure (NSDQ:NVCR) today touted the results of a retrospective sub-group analysis of its EF-14 Phase III pivotal trial in patients with newly diagnosed glioblastoma. The analysis, which was published in the Journal of Neuro-Oncology, demonstrated that more time on Novocure’s Optune device predicted increased survival in people who received Optune plus temozolomide compared to those who received […]
Pops Diabetes wins FDA clearance for blood glucose monitoring system
Pops Diabetes Care said this week that the FDA cleared its Pops! one blood glucose monitoring system. The Minneapolis-based company’s device can be attached directly to the back of a mobile phone and interacts with the user through a coaching app. The Pops! one system also allows users to review their blood glucose trends and share […]
Alimera Sciences wins Health Canada nod for diabetic macular edema implant
Alimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema. The Iluvien device is a sustained release implant that delivers fluocinolone acetonide and is indicated to treat diabetic macular edema in people who have been previously given corticosteroids and did not have a clinically […]
Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy. The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer. Get the full story at our sister site, Drug Delivery Business News.
Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device. The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. […]
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