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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 23, 2024

View Archived Issues
Acryl

Acryl cleared as Korea’s first AI DTx to screen, diagnose depression

South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data. Read More
Judge's gavel with US flag

FDA likely to see more legal challenges to rulemaking, guidance in 2025

The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year. Read More
Illustration of head with circuit board brain

BCI devices make strides

Companies developing brain-computer interface (BCI) technologies certainly stepped up their activities this year with several starting to implant their devices into humans. After decades as an experimental technology pursued exclusively in research settings, BCI devices could be just a few years away from entering clinical practice – and investors are paying attention. Read More
FDA-yellow-dice.png

​FDA releases second advisory under early alert program​

The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place. Read More
Stock market charts

Med-tech gainers and losers for Dec. 16-20, 2024

The top 10 med-tech stock gainers and losers for the week. Read More

Appointments and advancements for December 23, 2024

New hires and promotions in the med-tech industry, including: Optimizerx. Read More

Financings for December 24, 2024

Med-tech firms raising money in public or private financings, including: Varex. Read More

Other news to note for December 23, 2024

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axena, Eisai, Flomics, Fujirebio, H.U. Group, Lucid, Oncodia, Renavaro, Roivios, Singular Genomics. Read More

Regulatory actions for December 23, 2024

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardia Medical, Sequana Medical. Read More

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