Ortho Clinical Diagnostics said yesterday that its Vitros insulin assay and calibrators won 510(k) clearance from the FDA. The Raritan, N.J.-based company reported that the diabetes and pre-diabetes diagnostic test is slated to be commercially available in the 3rd quarter of this year. The Vitros insulin assay is part of Ortho’s diagnostic platform for diabetes, […]
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Baxter integrates DoseEdge with Epic’s Willow pharmacy system
Baxter (NYSE:BAX) said today it will integrate its DoseEdge Pharmacy workflow manager with the Epic Willow Impatient Pharmacy system. The Deerfield, Ill.-based company said that the bi-directional integration between the dedicated intravenous workflow system and electronic medical records to help hospitals meet compliance requirements with the Centers for Medicare & Medicaid Services and other payors. “Every time […]
Icon Bioscience touts FDA NDA submission for Dexycu
Icon Bioscience said today that the FDA accepted the company’s submitted new drug application for its Dexycu drug designed to be used as an anti-inflammatory following cataract surgery. The Newark, Calif.-based company’s Dexycu utilizes the company’s Verisome novel drug delivery system designed to treat ophthalmic diseases and slowly release the drug while the Verisome system […]
Medtronic inks diabetes deal with Aetna
Medtronic (NYSE:MDT) said today that it inked a deal with health insurer Aetna (NYSE:AET) to measure outcomes for patients with Type 1 and Type 2 diabetes on multiple daily insulin injections. The program is designed for patients who elect to move to an insulin pump, using a Medtronic pump with its SmartGuard tech and its […]
West Pharmaceutical Services touts needle shield
West Pharmaceutical Services has expanded its product offerings to include the Rigid Needle Shield (RNS). The RNS helps add safety to profiled syringes with a staked needle. It also helps ensure the integrity of injectable drug products. “Pharmaceutical companies continue to look for drug packaging and delivery solutions that offer safety, efficiency and an improved […]
Semnur touts Phase I/II trial of non-opioid pain-killer
Semnur Pharmaceuticals touted data today from a Phase I/II pharmacokinetic trial of its injectable, non-opioid pain-killer, SP-102. The trial enrolled 12 patients with radicular pain. The trial met its primary endpoint and showed that single epidural injection of SP-102 could provide a sustained analgesic effect for 1 month. The company touted its product, which is […]
Tiny bubbles get past blood-brain barrier for targeted drug delivery
The blood-brain barrier plays an important role in protecting the human brain from harmful toxins. But it also stops potentially helpful drugs from reaching the brain. Now, researchers believe that tiny bubbles loaded with drugs and delivered using ultrasound could overcome the obstacles presented by the protective network of vessels. Researchers at the University of […]
Medtech stories we missed this week: June 23, 2017
From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for […]
Camarus, Braeburn tout Phase II data for long-acting buprenorphine depot
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder. The in-patient trial included 5 3-day test sessions to evaluate the patients’ response to randomized […]
FDA approves diagnostic that simultaneously screens for multiple cancer biomarkers
The FDA said today that it awarded premarket approval to Thermo Fisher Scientific‘s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with 3 approved therapies for non-small cell lung cancer. The company’s Oncomine Dx Target Test evaluates 23 genes associated with non-small cell lung cancer. The tests results could help […]