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Abbott Issues Correction On Faulty Glucose Monitors

Abbott has issued an urgent voluntary medical device correction for a small number of FreeStyle Libre 3 sensors distributed in the US during May. The sensors could give inaccurate readings, the company explained.

Diabetic Care Patient Monitoring

Inspections Of Chinese Syringe Manufacturer Prompts Additional Warnings

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.

FDA Warning Letters

FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse

The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.

FDA Guidance Documents

Philips Was Correct In Disputed Death Reports, FDA Confirms

Last month, the US FDA increased the number of injuries and deaths initially reported in a March recall from Philips, which the company disputed. The FDA now says its adjusted numbers were in error.

FDA Recalls
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Deals and Financings

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News We’re Watching: Edwards Scoops Up Cardio Firms, BD And Quest Partner, Admera Settles Kickback Case

This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the government $5m for violating anti-kickback law; eCential Robotics’ spine platform made its debut for human use; and more.

Commercial Regulation

Biolinq Aims To Transform Diabetic Glucose Monitoring With Needle-Free Patch

Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

Diabetic Care Innovation

TRiCares Secures $50M For Tricuspid Replacement System, Topaz

TRiCares SAS announced it raised $50m in series D funding from a single unnamed investor. The funding will support the company’s upcoming US early feasibility study and EU CE mark clinical investigation for its transfemoral tricuspid heart valve replacement system, Topaz.

Europe US States

Magenta Medical Secures $105M To Advance ‘World's Smallest Heart Pump’

Magenta Medical is preparing to launch a pivotal trial for its Elevate percutaneous Left Ventricular Assist Device, armed with $105m in new funding announced on 23 July. The company’s minimally invasive, FDA-designated Breakthrough Device supports heart function during high-risk percutaneous coronary intervention procedures.

Europe US States
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Market Access

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Medtech Connect 16: AI For Cross Border Regulation

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

Digital Health Manufacturing

China Market For Medtech: Opportunity Or Headache?

Medtech companies have typically seen a “mixed picture of growth” in China in the past year or two, but it is a market that requires ongoing commitment, a panel of experts argued at the MedTech Forum 2024.

China Market Access

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

FDA Patents

FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

Regulation FDA
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Market Intelligence

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WHO Launches 'One-Stop Shop' For Global Information On Medical Devices

The Medical Devices Information System (MeDevIS) platform, launched by the WHO this week, consolidates information on 2,301 device types and streamlines device nomenclature to support informed decision-making by governments, regulators, payers, and healthcare providers.

International Supply Chain

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
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Appointments

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Executives On The Move: June 2024

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

Leadership Executive Changes

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
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