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ADDF Leaders Discuss Future Strategies In Alzheimer’s Research And Crucial Role Of Diagnostic Markers

Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.

BIO Neurology

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

Zeto Wins FDA Clearance For Novel Seizure Detection Device

The US FDA has granted 510(k) clearance to a California medical technology company for a brain monitoring device that detects seizures in patients with brain injury or trauma.

FDA Innovation

FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

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Deals and Financings

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Deloitte Tackles Pros and Cons of Europe For Medtech

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

Europe Market Intelligence

Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

Women's Health Financing

News We’re Watching: Medtronic Recall, More Chinese Syringe Woes, Surgical Robot Clearance

This week, Medline announced recalls of tracheal tubes; Eko Health raised $41m in Series D funding; and the US FDA announced participation in collaborative communities focused on brain-computer interface devices and more.

Approvals FDA

Deals Shaping The Medtech And Diagnostics Industries, May 2024

An interactive look at medtech and diagnostics deals made during May

Deals Financing
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Market Access

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Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

Europe EU

FDA Implements Authority To Destroy Certain Medical Devices, Amends Final Rule To Provide Device Owners Prior Notification

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

FDA Enforcement

FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

FDA OTC Devices
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Market Intelligence

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Deloitte Tackles Pros and Cons of Europe For Medtech

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

Europe Market Intelligence

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

Europe EU

German IVDs At The Turning Point: Digital And AI Show Future Market Direction

Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.

Germany Policy

J&J Refines Direction For Ottava

Delays have plagued J&J's soft tissue surgical robot. However, the company has now solidified at least its near-term plan and hopes to commence trials later this year.

Robotic Surgery Business Strategies
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Appointments

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Illumina Appoints Ankur Dhingra CFO

Ankur Dhingra has replaced Joydeep Goswami as Illumina’s chief financial officer after Goswami spent just 14 months on the job. The San Diego-based sequencing and array tech company also appointed Jakob Wedel as chief of strategy and corporate development officer.

Executive Changes Commercial

Execs On The Move: February 2023

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Commercial Executive Changes

Execs On The Move: January 2024

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Medical Device Commercial

News We’re Watching: LivaNova Names CEO; Surgical Robot Goes To Space, And More

Medtech Insight's News We're Watching highlights medtech industry developments we are following: LivaNova named a new CEO, Roche confirmed plans to launch a continuous glucose monitor, Virtual Incision sent its surgical robot into orbit, and Synchron announced a deal with Acquandas to advance its brain interface technology.

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