The U.S. Dept. of Homeland Security issued an advisory this week, warning consumers that BD’s (NYSE: BDX) Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker unauthorized access to the device when it is connected to a terminal server. BD determined that the affected products are not sold within the U.S., a […]
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Tracking tumors with Precipio’s liquid biopsy tech
In the era of personalized medicine, cancer patients will often have their tumors biopsied and analyzed as doctors hunt for mutations that are driving the patient’s condition. For some forms of cancer, doctors can recommend therapies that target particular genetic changes. “The problem is – and this is why cancer is such a tough disease […]
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
NeuroMetrix lands $4m milestone payment from GSK deal
NeuroMetrix (NSDQ:NURO) said this week that it reeled in a $3.8 million milestone payment from its collaboration with GlaxoSmithKline‘s (NYSE:GSK) consumer healthcare unit. The strategic deal between the two groups was first announced in January this year. According to the terms of the deal, GSK acquired exclusive ownership of NeuroMetrix’s Quell pain-relief device outside the U.S., […]
Valeritas launches V-Go insulin delivery device in Australia
Valeritas (NSDQ:VLRX) said today that it launched its V-Go wearable insulin delivery device in Australia. The company inked an exclusive distribution agreement in Australia with AMSL Diabetes earlier this year. According to the terms of the deal, Valeritas will be responsible for product development, regulatory approval, quality management and manufacturing. AMSL Diabetes will take over the […]
Dexcom acquires diabetes management tech with TypeZero purchase
Dexcom (NSDQ:DXCM) said this week that it acquired TypeZero Technologies and its personalized diabetes management solutions. The financial details of the transaction were not disclosed. Dexcom plans to support the first commercial launch of an automated insulin delivery system using TypeZero’s inControl algorithm next year. In March, Dexcom’s latest continuous glucose monitor became the first CGM to […]
Urotronic raises $20m for drug-coated balloon catheter
Urotronic has raised $20 million in an equity offering involving 7 investors, according to a document filed with the SEC this week. The Minnesota-based company is developing a drug-coated balloon catheter designed to treat urethral strictures in men. Urotronic’s latest fundraising efforts come on the heels of a $6 million offering that closed in July. Earlier this year, […]
FDA extends expiration date for swath of Mylan’s Epipens amid shortage
In an attempt to mitigate an ongoing shortage of Epipen auto-injectors, the FDA today extended the expiration date of specific lots of 0.3-mg devices by four months. The move to extend the expiration dates beyond the approved 20-month shelf-life is based on stability data provided by Mylan (NSDQ:MYL) to the FDA, the U.S. regulatory agency reported. “Many […]
Ichor touts use of electroporation drug-delivery system in cervical cancer trial
Ichor Medical Systems said today that its TriGrid electroporation drug-delivery system was tapped for a Phase Ib/II clinical trial to administer an investigational therapeutic HPV DNA vaccine, GX-188E, developed by Genexine Inc. The trial is designed to test the efficacy of a DNA vaccine combined with an anti-PD-1 therapy in patients with HPV-induced advanced non-resectable […]
Xeris Pharmaceuticals kicks off dual-hormone artificial pancreas trial
Xeris Pharmaceuticals (NSDQ:XERS) said last week that it launched a Phase I trial of its ready-to-use liquid glucagon in a closed-loop, dual-hormone artificial pancreas system. Automated insulin delivery systems represent the latest advancement in diabetes management. But these technologies fall short of performing the tasks of a human pancreas – they deliver insulin, but they […]