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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.

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.

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.

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.
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.
Period-Tracking Apps Should Safeguard Data, Reassure Customers In Post-Roe Era
With Roe v. Wade In Rearview, What’s Next For Women’s Health?
Don’t Trust That (Femtech) App – Most Health Apps Don’t Meet ORCHA’s Data Privacy, Assurance Standards
Natural Cycles Fertility App Wins FDA Clearance For Oura Ring Integration

Maureen Kenny, 1963-2022
Kenny, a mainstay of our publications for three decades, has passed away in London.

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.

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.
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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.

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.
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.
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.
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.
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.
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.
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.
Quality Control & Compliance Explore this Topic
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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.
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.
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.
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.
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.
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.
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.
Execs On The Move: Accuray, Acutus Promote New CEOS In July
An interactive view of medtech executive changes from the month of July 2022.
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.
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.
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.
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.
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.
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.
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.
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.
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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