The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]
Medtronic warns patients of MiniMed insulin pump safety issue
Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping […]
BD launches syringe-autoinjector combo
Becton Dickinson (NYSE:BDX) today announced the launch of the BD Intevia 1mL two-step disposable autoinjector, which combines an autoinjector and pre-fillable syringe in one integrated system. BD Intevia disposable autoinjector is a 2-step push-on-skin device that is designed to effectively and safely inject a variety of drugs of different viscosities up to 35cP and different […]
Aptar Pharma’s two-dose nasal spray device to deliver epinephrine
Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar’s Bidose (BDS) nasal device to deliver Bryn’s epinephrine nasal spray (BRYN-NDS1C). Crystal Lake, Ill.-based Aptar’s Bidose tech enables two-shot nasal drug delivery and will replace the need to carry two epinephrine auto-injectors, according to the companies. Last March, Aptar won FDA approval to […]
Judge adds $10m in damages in Vectura-GSK patent spat
This article has been updated with a statement from Glaxo Smith Kline. A federal judge in Delaware has awarded British inhaler company Vectura an additional $10.5 million in compensatory damages from Glaxo Smith Kline (NYSE:GSK) in a patent dispute. In May, a jury awarded Vectura $89.7 million in damages for the period from August 2016 […]
Cook Regentec launches blood filtration trial for critical limb ischemia
Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]
Medtronic lands reimbursement for MiniMed 670G pump in Germany
Medtronic (NYSE:MDT) said today it has secured reimbursement for its MiniMed 670G insulin pump system from regulators in Germany. The German Federal Association of the Statutory Health Insurances (GKV-SV) granted reimbursement for the smart insulin pump for patients with type 1 diabetes, according to the company. In May, Medtronic released real-world data from more than 8 […]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, […]
Report: Dexcom shares drop in response to ‘headwinds’ comment
Shares in Dexcom (NSDQ:DXCM) dropped nearly 6.8% this morning following comments by a company executive that the company is facing “headwinds” that could hamper third-quarter results, according to a report by SeekingAlpha. EVP and CFO Quentin Blakford told attendees at Morgan Stanley’s Healthcare Conference in New York that comparisons to Q3 2018 results could be […]
- « Previous Page
- 1
- 2
- 3
- 4
- 5
- …
- 8
- Next Page »
