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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Oct. 18, 2021

View Archived Issues
Rendering of histotripsy treatment head and targeted destruction of liver tissue

Histosonics lands FDA breakthrough device designation

The FDA granted breakthrough device designation to Histosonics Inc. for the first system to harnesses microbubbles created by pulsed ultrasound waves to wreak very targeted cellular destruction, with real-time visualization and control. The therapy, called histotripsy, destroys tissue in the liver without heat, radiation or surgery. The technology was developed at the University of Michigan. Read More
Cancer-and-Cancer-immunotherapy.png

Inbiomotion touts phase III data for breast cancer companion diagnostic

A genetic biomarker-based diagnostic test developed by Inbiomotion SL to identify treatment for early-stage breast cancer could significantly improve patient survival, a study has found. Data from the phase III NSABP-B34 study published in the Journal of the National Cancer Institute Cancer Spectrum, showed that in patients with MAF-negative (mutation biomarker) tumors – determined with Inbiomotion’s MAF Test – adjuvant treatment with clodronate was associated as having the greatest benefit compared to placebo-treated control patients receiving the same standard of care. Read More
AI silhouette

Aaronson says demographic representation in AI is important, but clinical validation is the key

The question of bias in artificial intelligence (AI) algorithms is generally thought to be overcome by ensuring that the data set used to train the algorithm is representative of the population at large. However, Naomi Aaronson, executive director of clinical evaluation at the Blue Cross Blue Shield Association, said its not that simple because demographic data can combine in unpredictable ways and thus “the only real understanding of whether it works is in the clinical validation” of the algorithm in various settings. Read More
Cancer cells under magnifying glass

Berry Oncology shows promising data on early screening for six cancers

Oncology genomic testing company Berry Oncology Corp.’s latest research results showed promising data for its Hifi platform-based technology, its CEO Jun Zhou said during the first International Biopharma Industry Week held in Shanghai. With the Hifi liquid biopsy test, users can receive early screening of six cancers, including liver cancer, lung cancer, gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, with an overall sensitivity of 87.6%, specificity of 99.1%, and overall tissue of origin precision in 82% of positive cancers. Read More
Rapid testing result for COVID-19

NIH adds another $78M into RADx for 12 new rapid tests for COVID-19

The U.S. National Institutes of Health reported Oct. 14 that it has awarded contracts in the amount of $77.7 million for development and manufacture of a dozen new rapid tests for the SARS-CoV-2 virus. The monies were awarded under the NIH’s Rapid Development of Diagnostics (RADx) program, and will add seven viral antigen detection and five viral RNA detection tests to the suite of offerings. all with an eye toward more rapid turn-around of test results. The news of the new round of RADx grants was followed by 24 hours the announcement that the Department of Health and Human Services has extended the public health emergency (PHE) for the COVID-19 pandemic for another three months. Read More

Appointments and advancements for Oct. 18, 2021

New hires and promotions in the med-tech industry, including: Cleerly, Geneoscopy, Immunovia, Insulet, Xenter. Read More

Financings for Oct. 18, 2021

Med-tech firms raising money in public or private financings, including: Aditxt, Apollo Endosurgery, Paragon 28, SPR Therapeutics, X-trodes. Read More

In the clinic for Oct. 18, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Inari Medical, Intuitive Surgical, Masimo. Read More

Other news to note for Oct. 18, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Check-Cap, Janssen, Johnson & Johnson, Visualdx. Read More

Regulatory actions for Oct. 18, 2021

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Histosonics, Thermo Fisher Scientific. Read More

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