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Philips In Talks With DOJ Over Breathing Machine Recalls

After being subpoenaed by the US Department of Justice in April, Philips says it is negotiating with the department on a consent decree addressing numerous recalled breathing devices made by Philips Respironics.

FDA Recalls Durable Medical Equipment

Medtech Multinationals Up Pace Of Localization Strategies In China

China-specific go-to-market strategies are helping global medtechs access the fast-growing medical device market in China, where localization has become the buzzword for foreign players, writes news and analysis portal Omdia.

China Business Strategies Policy

Eight Indicted In Alleged Genetic Testing Fraud

The eight had ties to a group of Tennessee labs that reportedly paid physicians to order medically unnecessary testing, billing Medicare more than $150m in five years.

Policy Legal Issues Enforcement

Agetech Innovators Take On Fall Prevention, Mobility Challenges For Older Adults

As the global population ages, a crop of tech startups is rising to meet seniors’ needs and improve quality of life, including by keeping them upright and mobile.

Digital Health Innovation Artificial Intelligence

Spotlight On Femtech

Citeline Podcast Special: The Shifting Landscape For Drugs And Devices Post-Roe v. Wade

 A special podcast featuring editors Elizabeth Orr and Marion Webb from Medtech Insight, Brenda Sandburg from Pink Sheet and Malcolm Spicer from HBW Insight discussing the US Supreme Court’s historic overturning of Roe v. Wade and implications for FDA-regulated sectors, from the abortion pill and OTC daily and emergency contraceptives to intrauterine devices and period-tracking apps.  

Legal Issues Gynecology & Urology

Maureen Kenny, 1963-2022

Kenny, a mainstay of our publications for three decades, has passed away in London.

Regulation BioPharmaceutical Medical Device

Road To Modernization A Bumpy One For FDA, Says Woodcock

During a webinar hosted by the Alliance for a Stronger FDA, the US agency’s Deputy Commissioner Janet Woodcock discussed the FDA’s efforts to modernize how it collects and analyzes data.

FDA Legislation Regulation

EU Reference Laboratory Candidates Invited To Apply In Context of IVDR Regulation

The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.

EU Europe Medical Device

Medtech Monthly Podcast

In This Episode:

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics. >More Podcasts

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Click here to access further medical device and diagnostics news.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Medtech Industry Mourns US Rep. Jackie Walorski

Indiana Republican Congresswoman Jackie Walorski, who died in a car crash Wednesday, was a strong proponent of device industry priorities such as device tax repeal and Medicare coverage for innovative technologies.

Politics Policy United States

US FDA Looks To Balance Device Sterilization With Environmental Concerns

While half of all medical devices in the US are sterilized with ethylene oxide, emissions from the gas pose potential environmental hazards that are attracting federal action.

FDA Regulation Medical Device

Latest From Policy & Regulation

Warning Letter Close-Outs – June-July 2022

The US FDA released four close-out letters in June and July, publicly resolving warning letters issued to manufacturers of wound dressings, artificial hips, IUDs and disposable electrodes.

Warning Letters Regulation

Eight Weeks Left For Consortia To Apply For Over E165m Of Innovative Health Initiative Funding

The 20 September deadline for proposals takes the EU one step closer to the appointment of the first new Innovative Health Initiative IHI consortia involving medtech.

EU Europe

Warning Letter Roundup & Recap – July 2022

A manufacturer and importer of COVID-19 tests was cited for distributing unauthorized devices as well as GMP violations in the only warning letter issued to a medtech company last month.

Warning Letters FDA

Latest Italian Designation Means Germany And Italy Are Home To Half EU’s MDR Notified Bodies

While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue.

EU Europe

US Agencies Publish Guidance To Ensure Telehealth Access Equality

The US Departments of Health and Human Services and Justice have published guidance on protections in federal laws to help Americans with disabilities or limited English proficiency to access telehealth. The guidance coincides with the 32nd anniversary of the American with Disabilities Act.

Policy Diversity & Inclusion

Natural Cycles Fertility App Wins FDA Clearance For Oura Ring Integration

The app, the first to be approved with a birth control indication, can now sync data directly from the Oura Ring, a wearable device that tracks user’s biometrics.

Regulation Commercial

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

Warning Letter Close-Outs – June-July 2022

The US FDA released four close-out letters in June and July, publicly resolving warning letters issued to manufacturers of wound dressings, artificial hips, IUDs and disposable electrodes.

Warning Letters Regulation

Eight Weeks Left For Consortia To Apply For Over E165m Of Innovative Health Initiative Funding

The 20 September deadline for proposals takes the EU one step closer to the appointment of the first new Innovative Health Initiative IHI consortia involving medtech.

EU Europe

FDA Online Tracker Now Accepting Premarket Submissions

The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.

FDA Medical Device

Commercial Explore this Topic

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Medtech Monthly, Ep. 2: Where Does Diabetes Tech Stand In 2022?

In this edition of Medtech Monthly, Robert Gabbay, chief scientific and medical officer for the American Diabetes Association talked to Medtech Insight about diabetes tech, where it's headed, and what it could mean for preventative care.

Medtech Monthly Diabetic Care Leadership

Latest From Commercial

Inflation, Supply Chain Headaches And Staffing Shortages: CEOs Talk About 'Big Picture' Challenges

Although procedure volumes have mostly recovered from the shock of COVID-19 two years ago, the effects of the pandemic on the medtech sector and the economy overall will be felt for years to come. In recent analyst and sales and earnings presentations, CEOs of major medtech companies faced questions about how their company is handling these major "macro" issues.

Leadership Sales & Earnings

Minute Insight: NeuroOne Amends Deal With Zimmer Biomet To Shore Up Balance Sheet

Zimmer Biomet agreed to amend its exclusive development and distribution agreement with NeuroOne to pay $3.5m for 350,000 of stock. The deal will help NeuroOne continue to develop its Evo stereoelectroencephalography brain-mapping electrodes without further diluting the company’s stock.

Minute Insights Neurology

FDA Online Tracker Now Accepting Premarket Submissions

The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.

FDA Medical Device

Execs On The Move: Accuray, Acutus Promote New CEOS In July

An interactive view of medtech executive changes from the month of July 2022.

Executive Changes Commercial

Natural Cycles Fertility App Wins FDA Clearance For Oura Ring Integration

The app, the first to be approved with a birth control indication, can now sync data directly from the Oura Ring, a wearable device that tracks user’s biometrics.

Regulation Commercial

Minute Insight: Insulet Launches Omnipod 5 US-Wide Following Trial Period

After six months, the Omnipod 5 has seen its limited market launch expanded to cover the entirety of the US market.

Diabetic Care Launches

Clinical R&D Explore this Topic

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FDA Clears iRhythm’s Afib-Detecting Wearable Running Software Co-Developed By Verily

The ZEUS (Zio ECG Utilization Software) system for iRhythm’s Zio Watch detects and characterizes atrial fibrillation over time to aid doctors in diagnosing the condition. The company expects to begin commercializing it next year.

Digital Health Artificial Intelligence Patient Monitoring

Latest From Research & Development

Minute Insight: Withings Teams Up With Medable On Decentralized Trials

Withings’ health division is partnering with Medable to facilitate decentralized clinical trials.

Digital Health Clinical Trials

Minute Insight: AbbVie Bets Big On Glaucoma Market With iSTAR Purchase Deal

The pharmaceutical company has made a bold play to expand its presence in the device space, giving iSTAR upfront cash in a deal that grants it the right to buy iSTAR for almost half a billion dollars.

Ophthalmic Clinical Trials

Abbott’s Plan For DBS Depression Therapy Wins FDA’s Breakthrough Designation

Abbott continued St. Jude Medical’s prior research on deep brain stimulation for treating depression and has advanced the technology far enough that the US FDA now believes it could be a breakthrough treatment for treatment-resistant depression.

Behavioral Health Neurology

Telemedicine Among Sticky Wickets As Uncertainty Abounds Post-Roe v. Wade

The Supreme Court’s June decision overturning Roe v. Wade has sown confusion among abortion service providers, including in telehealth contexts, as a new legal framework develops across the US.

Gynecology & Urology Telehealth

Minute Insight: Lumos’ Bacterial-Viral Infection Differentiation Test Flops At FDA

Lumos Diagnostics is considering an appeal of the agency’s decision to refuse market clearance for its FebriDX test.

Regulation In Vitro Diagnostics

FDA Clears Eko’s Smart Stethoscope To Detect Heart Murmurs

Eko’s Murmur Analysis Software is the first and only electronic stethoscope software identify and differentiate sounds indicative of valvular heart disease from so-called “innocent” heart murmurs.

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