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BioWorld - Thursday, December 18, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 18, 2019

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One Drop snags $40M in Bayer-led series B, charts path beyond diabetes

Bayer AG led a $40 million series B financing for Informed Data Systems Inc. (IDS) and its One Drop diabetes management platform. The pharma giant also inked a licensing agreement to leverage IDS, which does business as One Drop, in therapeutic areas beyond diabetes and secured a seat on One Drop's board of directors. Read More

Dreamed wins U.S. and EU approval for AI-based insulin recommendation technology

HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI). Read More

Stakeholders resistant to participation mandate in radiation oncology APM

The Medicare radiation oncology alternative payment model is yet another attempt to control Medicare spending growth, but provider groups and device makers oppose mandatory program participation. Varian Medical offered a blistering critique of the participation mandate, stating that the participation mandate suggests that the U.S. Centers for Medicare and Medicaid Services (CMS) is less interested in a valid test of the program than it is in generating immediate savings. Read More

Cryoablation system to expand Boston Sci's global profile in interventional oncology

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Financings

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Appointments and advancements

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Daily M&A

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Regulatory front

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Other news to note

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Product clinical data for Sept. 17, 2019

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Product regulatory actions for Sept. 17, 2019

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BioWorld MedTech's Oncology Extra

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FDA grants IDE approval for pivotal study of Avita Medical's Recell system

Melbourne, Australia-based regenerative medicine company Avita Medical Ltd. has received good news from the FDA. The company, which also has a presence in Valencia, Calif., said the agency gave its thumbs up to an investigational device exemption application for a pivotal trial (NCT04091672) evaluating the safety and effectiveness of the Recell autologous cell harvesting device in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, crush wounds, abrasions, lacerations and surgical wounds. Read More

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