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Medical Devices Japan

Ropes & Gray LLP

Regulatory Landscape for AI-enabled MedTech in APAC

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Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

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On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 12

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In Washington:  On Feb. 23, officials from five major vaccine companies will be testifying before the House Energy and Commerce Subcommittee on Oversight and Investigation.  Chairperson Diana Degette (D-CO) will be holding a...more

Morrison & Foerster LLP

Japan Moves To Tighten Restrictions On Foreign Investment In Healthcare Industries

Amid concerns about predatory acquisitions of weakened companies and strategic assets during the COVID-19 crisis, more and more countries are restricting foreign direct investment (FDI) in their domestic companies, especially...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more

Knobbe Martens

Cyberdyne Bringing HAL Cyborg Exoskeleton to US Market

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Cyberdyne, a Japan-based robotics technology company, recently announced its collaboration with Brooks Rehabilitation and the Brooks Cybernic Treatment Center to bring its Hybrid Assistive Limb (HAL®) exoskeleton to the U.S....more

Knobbe Martens

Cyborg-Enhanced Physical Therapy Approved

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Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services. Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Biosimilar Uptake and Patent Litigation in Japan

Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more

Knobbe Martens

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

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On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the...more

Morrison & Foerster LLP

Top Ten International Anti-Corruption Developments for June 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

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Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

K&L Gates LLP

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

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On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

K&L Gates LLP

Global Food, Drug and Medical Device Newsletter

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In this issue: Legislative Updates: - (i) USA - (ii) EU - (iii) China - (iv) Australia - (v) Japan. - Featured Articles: - (i) Caffeinated Energy Drinks - a Global Perspective - (ii)...more

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