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BioWorld - Monday, July 13, 2026
Home » Topics » Medical technology

Medical technology
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US FTC: Apokyn suit has broad implications

March 22, 2023
By Mari Serebrov
Citing significant implications for patients with advanced Parkinson’s disease, as well as the broader public interest that’s at stake, the U.S. FTC filed an amicus brief in Sage Chemical Inc.’s district court challenge of Supernus Pharmaceuticals Inc.’s strategies to block generic competition of its injectable Parkinson’s drug, Apokyn (apomorphine).
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US PTO offers blessed relief for small inventors in new patent fee schedule

March 21, 2023
By Mark McCarty
As Medtronic plc. is fond of pointing out, the garage inventor has been the stuff of legend in U.S. business lore, providing a wide range of economically impactful inventions over the two-plus centuries since the U.S. patent system came into being.
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digital health

Digital health investments continue to grow in EU

March 21, 2023
By Bernard Banga
Early-stage venture capital firm Karista SAS reported the third edition of its European digital health funds mapping report. This mapping included all funds with global headquarters in France, Germany, Spain, Italy, the U.K., Netherlands, Austria, Luxembourg, Belgium and the Nordics.
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Edwards joins tech companies in challenging US PTO’s standard for inter partes reviews

March 21, 2023
By Mark McCarty
Edwards Lifesciences Inc., has joined Apple Inc., and several tech companies in suing the U.S. Patent and Trademark Office (PTO) over PTO’s administration of the inter partes review (IPR) process in a lawsuit that reached the Court of Appeals for the Federal Circuit. The court recently rejected the challenge as to whether the PTO is empowered by the statute to determine whether an IPR could be instituted, but the agency may be forced to engage in the clunky rulemaking process to formally encode the so-called Fintiv standard for acceptance of IPRs.
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Brainomix - 360 E aspects software

Brainomix receives FDA clearance for stroke AI imaging software

March 21, 2023
By Shani Alexander
Brainomix Ltd. received U.S. FDA clearance for its Brainomix 360 E-aspects tool, a fully automated AI-imaging solution for stroke assessment. Powered by explainable AI, the Brainomix 360 E-aspects tool, which is already CE-marked, assesses non-contrast CT scans to automatically generate a score and measures the volume of ischemic signs. It also features an overlaid heatmap to visually assist clinicians when treating stroke patients.
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Regulatory actions for March 21, 2023

March 21, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advamedica, Brainomix, Etiometry, Graymatters Health, Inspire Medical Systems, Viz.ai.
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Other news to note for March 21, 2023

March 21, 2023
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clario, Epic, Fluoguide, Guardant Health, Glaxosmithkline, Invitae, Oxford Nanopore, Pathoquest, Progentec, Strados.
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In the clinic for March 21, 2023

March 21, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ancora Heart, Stimvia.
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Financings for March 21, 2023

March 21, 2023
Med-tech firms raising money in public or private financings, including: Pathmaker.
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Appointments and advancements for March 21, 2023

March 21, 2023
New hires and promotions in the med-tech industry, including: Advamed, Deep 6, Dopavision, Unlearn.AI.
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