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11/15/2019

Oncocyte has reached a deal to offer about $8.5 million of its shares to certain investors. The net proceeds are expected to support the development and marketing of its DetermaVu and Razor lung cancer assays, as well as for clinical trials.

11/15/2019

The FDA has granted approval for Hologic's 3DQuorum Imaging Technology, which is designed to reduce the number of images by 66% by reconstructing images into larger slices. The technology is expected to save one hour per every eight hours of interpretation.

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MedTech Dive
11/15/2019

The FDA has granted premarket approval for Axonics Modulation Technologies' r-SNM sacral neuromodulation device, which is indicated to treat overactive bladder and urinary retention. The device features a wireless charging system and is designed to last for 15 years inside the patient's body.

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MassDevice (Boston)
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urinary retention
11/15/2019

The FDA plans to publicly report on four patient deaths involving Boston Scientific's Watchman heart implant after it receives information from the company. The agency will include the details in its MAUDE adverse-events database.

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MassDevice (Boston)
11/15/2019

Following complaints of a possible failure mode, Smith & Nephew has issued a field safety corrective action to update its Profix 750 grams mallet cleaning and sterilization guide. The mallet's poly tip may become loose and come off during use, according to the complaints.

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MassDevice (Boston)
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Smith & Nephew
11/15/2019

The European Parliament's Committee on the Environment, Public Health and Food Safety has voiced concerns over the European Medicines Agency's delayed launch of a clinical trials portal and database, known as the Clinical Trials Information System. CTIS was originally due for audit in July 2017 but has been delayed repeatedly.

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Regulatory Focus
11/15/2019

Ipshita Mandal-Johnson teamed up with University of Cambridge classmate Christian Guyader to found the Global Biotech Revolution and the GapSummit, first held in 2014, which brings together present and future biotech leaders to meet global challenges in health care, energy, food, agriculture and climate change. Mandal-Johnson was succeeded by Anna Gould after stepping down from the role of president in 2017 to make way for fresh leadership, and the experience "helped me to build a non-academic career, and to not be afraid of taking career risks," writes Mandal-Johnson.

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Nature (free content)
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University of Cambridge
11/15/2019

Biogen's Virtual Plant Manager Tara Caiano was worried that as a millennial woman she wouldn't be taken seriously when she relocated from Boston to Switzerland to manage external supply-chain partners, but she says she's been respected since day one. "I'm actually a forensic scientist by background, so I have always been surrounded by males in a scientific field, and having to fight that much harder," Caiano said. "It's helped prepare me for this particular role."

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Outsourced Pharma
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Tara Caiano
11/15/2019

A respected federal toxicologist once called scientist Doris Rouse's tuberculosis drug candidate "brick dust," but the drug became the first approved for TB by the FDA, and Rouse was heartened to see the drug's effect on desperately ill patients in a TB ward in South Africa. Rouse, who helped launch the nonprofit Global Alliance for TB, says a female chemistry teacher in middle school was an early inspiration, and the presence of Nobel Prize-winning biochemist Trudy Elion may have helped quash gender bias at employer Burroughs Wellcome.

11/15/2019

Girls won the top five awards at this year's Broadcom Math, Applied Science, Technology, and Engineering for Rising Stars competition for the first time in the event's history. A panel of educators, scientists and engineers judged entrants on their science projects, performance on team challenges, and leadership, teamwork, problem solving and communication skills.

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ABC News
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Rising Stars