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8/22/2017

Wearable technology is moving beyond consumer-grade health and wellness devices. The devices are becoming more prominent in the regulated world of medical devices, pushing the envelope for monitoring different conditions, says Dr. Arthur Combs, chief medical officer at flexible electronics company MC10 in Lexington, Mass. In the future, patients wearing medical-grade wearables will be able to regularly transmit readings about medical conditions to their physicians, according to Combs. They will be able to perform a variety of tasks that are generally reserved for hospital visits. Read the story.

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Dr. Arthur Combs
8/22/2017

Ironwood Pharmaceuticals' Duzallo, or lesinurad and allopurinol, was approved by the FDA as a treatment for hyperuricemia in patients with gout whose serum uric acid levels cannot be controlled using allopurinol alone. The company is expected to launch the drug in the fourth quarter of 2017.

8/22/2017

A rolling submission of a new-drug application was initiated with the FDA by Alkermes for fast-track-tagged ALKS 5461, a samidorphan and buprenorphine combination administered orally once daily as an adjunctive treatment for major depressive disorder. The company expects the filing to be completed by the end of the year.

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FDA, Alkermes
8/22/2017

Alexion Pharmaceuticals received approval from the European Commission to expand the indication for Soliris, or eculizumab, to cover use as a treatment for adult patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. The drug, which is approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, will be initially marketed in Germany, with launches in other EU countries being evaluated by the company.

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BioCentury
8/22/2017

A recall was issued by Dierbergs Markets for Scampi Butter over undeclared fish, lobster, crab and shrimp, and Cabernet Grille Butter because it contains soy and wheat not listed on the label. The recalled products have sell-by dates of 8/16/17, 9/6/17 and 10/9/17 for the scampi butter and 8/19/17, 9/10/17 and 11/3/17 for the cabernet butter, which were both distributed to 25 retail stores in western Illinois and eastern and central Missouri.

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Dierbergs Markets
8/22/2017

The ProxiSure laparoscopic suturing device was released by Johnson & Johnson subsidiary Ethicon. The device aids in accessing target angles, securing knots and controlling bites during knot tying and suturing in general, bariatric, gynecological and colorectal surgeries.

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MassDevice (Boston)
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Ethicon, Johnson & Johnson, ProxiSure
8/22/2017

The FDA gave Creo Medical Group 510(k) clearance for the Speedboat RS2 device and the CROMA platform 49 days after the company's submission. The device is designed to facilitate minimally invasive removal of precancerous and early-stage cancerous lesions in the bowel through bipolar radiofrequency and use microwave energy to stop bleeding.

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Reuters, Digital Look
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Creo Medical Group
8/22/2017

Biotronik obtained approval from the FDA for its Edora HF-T QP magnetic resonance-conditional quadripolar cardiac resynchronization pacemaker, which has a battery life of almost 10 years and a volume of 15 cubic centimeters. The pacemaker features Biotronik Home Monitoring and closed-loop stimulation, as well as MRI AutoDetect that enables automatic adaptation of the device to an MRI imaging environment.

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FDA, Biotronik
8/22/2017

The FDA's Pediatric Advisory Committee will evaluate the use of cough medications with opioids such as codeine and hydrocodone in children, including benefit-risk considerations and current treatment procedures, on Sept. 11 after an FDA meeting in which the American Academy of Pediatrics and other health care organizations opposed opioid use for pediatric cough treatment. "All of this work is essential to reducing preventable harm from opioid-containing medications and keeping children safe," said FDA Commissioner Scott Gottlieb.

8/22/2017

Forage Genetics is conducting a field study of biotech clover, which includes a gene being targeted to produce condensed tannins in alfalfa to improve the absorption of protein in cattle by preventing it from being digested too quickly.