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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Oct. 25, 2024

View Archived Issues
Medtronic - Affera Mapping and Ablation System

Medtronic’s Affera PFA snags FDA approval

Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition. Read More
Australian money

Orthocell raises AU$17M to launch nerve repair product in U.S.

Regenerative medicine company Orthocell Ltd. raised AU$17 million (US$11.28 million) to launch its nerve repair product, Remplir, in the $1.6 billion U.S. market. Read More
Speech-bubble-pic.png

MIWG blasts FDA’s ‘piecemeal’ approach to regulated speech

The Medical Information Working Group again took up a question regarding U.S. FDA-regulated speech, citing the agency’s new misinformation draft guidance as an example of a piecemeal approach to regulated speech. Read More
BlinkLab Test

Blinklab digital app could change how autism is diagnosed

Children with autism spectrum disorder (ASD) often must wait years before they get a diagnosis, and that wait time can result in missed opportunities for changing behaviors associated with autism. Read More
Illustration of human body composed of molecules

Using black hole study methods, digital twins take aim at the patient black box

Currently, cancer therapy trial-and-error methodology is inefficient and unsustainable. Oncology is the worst therapeutic area for drug trial success; only 3.4% of drugs that enter phase I end up being FDA approved, and 57% fail due to poor drug efficacy in trials. Building tools that may aid in predicting an individual’s response to a specific therapy may help in reducing costs, guesswork, and importantly improve the outcome of patients and accelerate new drug development. Read More

Appointments and advancements for October 25, 2024

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

Financings for October 25, 2024

Med-tech firms raising money in public or private financings, including: Novus Diagnostics, Senseonics, Trinity Biotech. Read More

In the clinic for October 25, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Genedx, Seastar Medical, Skylinedx. Read More

Other news to note for October 25, 2024

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: B. Braun, Epicapture, Integrated Molecular Diagnostics, Jupiter Endovascular, Labgenomics, Levita, Meta, Mölnlycke, Transdiagen, Trinity. Read More

Regulatory actions for October 25, 2024

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

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