When DarioHealth (NSDQ:DRIO) CEO Erez Raphael looks at the medical device world, he sees solutions that were designed by healthcare professionals and doctors – and this presents a stark contrast with the consumer device industry, he pointed out. “We have seen there are a lot of cases, most of the cases in the industry, where the […]
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FDA approves first pill with sensor to track ingestion
The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]
Orthocell wins CE Mark for CelGro device
Orthocell (ASX:OCC) said today that its CelGro collagen medical device won CE Mark approval for a range of dental bone and soft tissue regeneration procedures. The company said it’s in talks with the strategic commercial partners to distribute its product throughout Europe and other key regions. Orthocell is also reportedly holding discussions with key opinion leaders […]
Urotronic launches feasibility trial of drug-coated balloon
Urotronic is launching a feasibility trial of its drug-coated balloon in men with narrowed urethras, according to StarTribune. The Plymouth, Minn.-based company’s Optilume device is inserted into a patient’s urethra and then inflates to dilate the urethra, allowing urine to leave the patient’s bladder. The Robust-II trial is slated to enroll 15 male patients and last […]
Study: Glytec’s diabetes management tech improves care for patients leaving the hospital
A prospective study conducted by Eastern Virginia Medical School showed that patients had no diabetes-related readmissions or ER visits within 30 days of leaving the hospital when providers used the Hospital-to-Home module of Glytec‘s eGlycemic diabetes management system. Twenty-eight people with diabetes were enrolled in the study and all of them had A1C levels above […]
EMD Serono wins FDA nod for redesigned pen injector
Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving […]
Q Biomed looks to dust off shelved cancer pain drug
Denis Corin has spent the last 13 years in the biopharmaceutical industry watching and learning from scientists and companies that fail. “I’ve seen so many promising and innovative young technologies really struggle along or die on the vine because they’re run by scientists who don’t really understanding capital raising,” he told Drug Delivery Business News. “They run […]
Innovus inks deal to sell Acon’s glucose monitoring kit
Innovus Pharmaceuticals (OTC:INNV) announced today that it has inked an agreement with its current partner, Acon Laboratories, to sell Acon’s FDA-cleared glucose monitor, test strips and lancet device. The San Diego, Calif.-based company plans to sell Acon’s glucose testing kit with its GlucoGorx glucose supplement. Innovus touted the kit as being able to provide glucose […]
Shares in Titan Pharmaceuticals fall after Q3 miss
Shares in Titan Pharmaceuticals (NSDQ:TTNP) fell today after the company missed expectations on Wall Street with its third quarter results. The San Francisco, Calif.-based company posted a net loss of -$4.2 million on sales of $40,000 for the 3 months ended Sept. 30, for bottom-line loss of -60% on sales growth of 53.8% compared with the […]
OncoSec Medical names new CEO | Personnel Moves – Nov. 9, 2017
OncoSec Medical (NSDQ:ONCS) announced earlier this week that the company’s co-founder, Punit Dhillon, would step down as CEO and continue to serve as president while Daniel O’Connor takes over the corner office. O’Connor joined OncoSec’s board of directors in September this year. “We are pleased to welcome Dan to OncoSec at this important time, and believe […]