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Featured Stories

Medtronic Recalls Cardiac Defibrillators Due To Reduced Shock Potential

The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.

Enforcement Recalls Regulation

No Quick Fix When It Comes To EU Medtech Notified Body Designations

Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.

EU Europe Medical Device

SyncThink Brings Eye-Sync Neurological Diagnostic To Europe

SyncThink recently obtained a CE mark for the Eye-Sync system, using the PicoXR Neo 3 Pro Eye virtual-reality headset, to measure and quantify eye-movement biomarkers reflective of neurological impairment or disease.

Artificial Intelligence Neurology Approvals

TikTok’s Owner Joins Trend Of Tech Giants Buying Health Providers

According to reports from Caixin and Bloomberg, TikTok’s Chinese owner ByteDance paid about $1.5bn for Amcare Healthcare, the operator of women’s and children’s hospitals in major Chinese cities.

China M & A Business Strategies

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

MedRhythms On First-To-Market Track With Prescription Music Therapy For Chronic Stroke

MedRhythms’ digital therapeutics platform aims to improve walking and functional outcomes in patients with multiple sclerosis, Parkinsons’ disease and chronic stroke. With around $32m in funding to date, the start-up boasts collaborations with major medical centers and a partnership with Biogen.

Digital Health Clinical Trials FDA

French Medtech System ‘Too Rigorous’ For Innovation To Flourish, Argues Healthtech Expert

David Caumartin is well versed in the both the benefits and drawbacks of being a France-based medtech innovator, having spent almost three decades in the local industry. The VP of France Biotech spoke to Medtech Insight about the new opportunities there to be seized, and the pitfalls to avoid.

Leadership Reimbursement Europe

Surgalign Pays $2M To Resolve SEC Investigation

US financial regulators said that the spinal device company falsely attributed future sales to the current quarter as a way to disguise lower-than-expected sales.

Regulation Enforcement Legal Issues

Medtech Monthly Podcast

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

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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

Class I Recall For BD Intraosseous Infusion System

The US FDA has labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation. 

FDA Recalls

Class I Recall For Haimen Shengbang Viral Sampling Containers

The US FDA has designated a recall of Haimen Shengbang Laboratory Equipment Co. viral transport media containers as class I, the agency’s most serious designation.

FDA Recalls

US FDA Invites Comments On How It Collects Device Info Through Q-Sub Program

The US agency’s Q-Submission Program provides medical device manufacturers the opportunity to receive information on the regulatory process related to devices in development.

FDA Regulation

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

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

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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

Class I Recall For Haimen Shengbang Viral Sampling Containers

The US FDA has designated a recall of Haimen Shengbang Laboratory Equipment Co. viral transport media containers as class I, the agency’s most serious designation.

FDA Recalls

US FDA Invites Comments On How It Collects Device Info Through Q-Sub Program

The US agency’s Q-Submission Program provides medical device manufacturers the opportunity to receive information on the regulatory process related to devices in development.

FDA Regulation

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

Commercial Explore this Topic

Set Alert for Commercial

Digital Health Roundup: Cardio Smart Watches, Pear Therapeutics Own 'Reset,' Agetech Boom

In this month’s Digital Health roundup, Medtech Insight’s Reed Miller talks about iRhythm and Withings’ smartwatches business, Barnaby Pickering reviews digital therapeutics Pear Therapeutics’ restructuring, and Marion Webb presents highlights from her new series on Agetech.

Digital Health Artificial Intelligence Clinical Trials

Latest From Commercial

Class I Recall For BD Intraosseous Infusion System

The US FDA has labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation. 

FDA Recalls

Minute Insight: FundamentalVR Raises $20M In Series B, Further Develop HapticVR For Surgical Training

Fundamental VR, which developed a virtual surgical platform that uses advanced technologies such as haptic (touch) feedback, announced on 11 August it raised $20m in a series B round led by EQT Life Sciences and prior investors Downing Ventures.

Financing Digital Health

How We Can Use the FDA’s 2022 Diversity Guidance to Make Our Clinical Trials More Inclusive

Catherine Gregor is the chief clinical trial officer at Florence Healthcare, a leading provider of clinical trial software that helps researchers collaborate and manage workflows and information. Based on her extensive experience in clinical research administration, Gregor explains how the recent US FDA guidance on diversity and inclusion in clinical trials represents a critical opportunity to make clinical research more inclusive and equitable.

Diversity & Inclusion Clinical Trials

Class I Recall For Haimen Shengbang Viral Sampling Containers

The US FDA has designated a recall of Haimen Shengbang Laboratory Equipment Co. viral transport media containers as class I, the agency’s most serious designation.

FDA Recalls

Minute Insight: Abbott Teams Up With WeightWatchers In Diabetes Management

The companies will link Abbott’s blood glucose monitoring devices to WeightWatchers’ smartphone apps and weight loss program.

Minute Insights Diabetic Care

Deals Shaping The Medtech And Diagnostics Industry, July 2022

Medtech Insight's Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics and Medical Devices – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in July 2022. Data provided by Biomedtracker.

Deals Financing

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

US CDC Teams Up With ACLA To Expand Monkeypox Testing

The US CDC and major laboratories across the country are working together to scale up testing capacity for monkeypox, especially now that it has been declared a public health emergency.

FDA Diagnostics Infectious Diseases

Latest From Research & Development

How We Can Use the FDA’s 2022 Diversity Guidance to Make Our Clinical Trials More Inclusive

Catherine Gregor is the chief clinical trial officer at Florence Healthcare, a leading provider of clinical trial software that helps researchers collaborate and manage workflows and information. Based on her extensive experience in clinical research administration, Gregor explains how the recent US FDA guidance on diversity and inclusion in clinical trials represents a critical opportunity to make clinical research more inclusive and equitable.

Diversity & Inclusion Clinical Trials

Exec Chat: Abbott Bets On Modular And Leadless Devices To Be The Future Of Cardiac Rhythm Management

Medtech Insight interviewed Leonard Ganz, a veteran cardiac electrophysiologist who recently joined Abbott’s cardiac rhythm management business as its divisional vice president of medical affairs and chief medical officer.

Exec Chats Clinical Trials

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

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

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
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