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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 27, 2020

View Archived Issues
8-26-Abbott_BinaxNow_kit

Abbott’s $5 COVID-19 rapid test wins FDA emergency use nod

The U.S. FDA has cleared the way for Abbott Laboratories sixth COVID-19 test, a near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment. The company has priced the Binaxnow COVID-19 Ag Card rapid test at $5 and is offering a complementary mobile app that allows people to display their test results when asked by organizations for verification. Read More
8-26-Foundation-Medical

FDA gives thumbs up to Foundationone Liquid CDx

Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test. Read More
Shipping container with flag of China

IBA beams its cancer therapy tech into China with licensing deal

LONDON – Ion Beam Applications SA (IBA) has taken a giant step into China, sealing a €100 million-plus (US$118.2 million) licensing deal with a local company to manufacture, install and maintain its proton beam cancer therapy systems. Read More

New DOJ interim rule codifies terms of Brand memo

The U.S. Department of Justice (DOJ) unveiled two interim final rules intended to deal with enforcement activities in connection with policies enunciated over the past four years, including the so-called Brand memo, which banned federal prosecutors from using federal agency guidance as leverage in prosecutions of private-sector entities. Read More
8-26-CT-scan

New AI technique could prevent medical imaging hacking and errors

Researchers at Ben-Gurion University of the Negev (BGU) presented a new artificial intelligence technique that could protect medical imaging systems from hacking and human errors at the 2020 International Conference on Artificial Intelligence in Medicine (AIME) on Aug. 26. Their innovative solution uses a dual-layer architecture that screens for two different types of anomalous instructions to capture those that are always unusual or outside of safe ranges and those that are inappropriate in the specific context. Read More

Appointments and advancements for Aug. 27, 2020

New hires and promotions in the med-tech industry, including: Axol Bioscience, BBS-Bioactive Bone Substitute, Nous Imaging, Novasignal, Valuehealth. Read More

Financings for Aug. 27, 2020

Med-tech firms raising money in public or private financings, including: Acto, Exsomed, Verto Health. Read More

In the clinic for Aug. 27, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Carl Zeiss Meditech, Eurofins, Tandem Diabetes Care. Read More

Other news to note for Aug. 27, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amazon, Applied DNA Sciences, Cergentis, Cerner, Emergent Connect, Iron Bow Technologies, Lunit, Natera, Novacyt Group, Owlytics Healthcare, Rewalk Robotics, Statera Spine, Utm:Healthcare, Viewray, Viimed, Vivos, Wenzel Spine. Read More

Regulatory actions for Aug. 27, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, B. Braun Medical, Cureapp, Foundation Medicine, Healeon, Med-El, Sanuwave Health. Read More

Regulatory front for Aug. 27, 2020

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, FDA, HHS, NICE, Stericycle Expert Solutions. Read More

BioWorld MedTech’s Diagnostics Extra for Aug. 27, 2020

Keeping you up to date on recent developments in diagnostics, including: A.I. tool promises faster, more accurate Alzheimer's diagnosis; Bioluminescent tool tracks DNA break repair; Mechanisms of retinopathy come into focus. Read More

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