Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Featured Stories

UK’s NICE Outlines Standards That AI and Data-Driven Medtech Should Meet For NHS Uptake

NICE, the body that produces health technology assessment guidance for England and Wales, has earlier this month introduced updates to its evidence standards guidance for developers of digital technologies based on artificial intelligence (AI) and on adaptive algorithms.

Europe United Kingdom EU

Exec Chat: Sequana Medical Pursues Dual Device-Drug Strategy For Fluid Overload

Speaking to Medtech Insight, Sequana Medical’s CEO discussed the company’s two technologies for combating fluid overload whilst explaining that, sometimes, chasing approval as a drug can be the best way to ensure easy market access.

Exec Chats Clinical Trials Innovation

Accessing Unapproved Medical Devices – Comparing The Singapore And US Experiences

What are the special regulatory pathways that allow the use of unapproved devices? Asia Regulatory Professionals Association’s Rachel Lee and Helena Baric supply the answer, with reference to the systems used in the US and Singapore.

Regulation Singapore United States

‘The Story That No One Likes To Hear’: Investors Looking For Surer Bets In Health Tech After Record 2021

A panel of investors and leaders in healtech expects investment in health tech to decline, but still foresees opportunities for companies working on solutions that will transform overall health care such as AI, ML, mental health and health equity.

Investor Eye Digital Health Financing

Brazilian Medtechs Leave Gloomy 2021 Far Behind As Exports Hit New High

Brazil's ABIMO medtech industry association reports newly-buoyant levels of export activity, as normal business routines crystalize further in the post-COVID phase. Meanwhile, member companies of the Brazil Health Devices initiative are outperforming industry averages.

Brazil Policy Medical Device

FDA Urges Stronger Labeling For Hydrogen Peroxide-Based Contact Lens Solutions

New draft guidance from the US agency calls for manufacturers to add more information about potential risks to the labeling of some types of contact lens solution.

FDA Guidance Documents OTC Devices

Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

FDA Warning Letters 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

Recent Tweets from Medtech Insight

Latest from PR Newswire

Click here to access further medical device and diagnostics news.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

As Cyberattacks On Hospitals Rise, Medical Devices Are Particularly Vulnerable

A wide-ranging report on cybersecurity raises many red flags for hospital network systems, especially for connected medical devices and patient data.

Cybersecurity FDA Medical Device

European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

EU Europe Medical Device

Latest From Policy & Regulation

Morcellation Use Drops After FDA Warning

Surgeons are opting for alternate hysterectomy methods since the FDA warned power morcellation may spread cancerous cells through the body.

Regulation FDA

Guidance Document Clarifies FDA’s Replacement Reagent Policy

The agency allows IVD developers to use assays with different instrument systems without submitting a new 510(k), as long as they meet certain safety and efficacy criteria.

Regulation Guidance Documents

Hear Ye! Hear Ye! Hearing Aids Coming To A Store Near You

The US FDA has finally established a new regulatory category for hearing aids that will allow Americans with mild to moderate hearing loss to purchase the devices directly over the counter without a prescription or prior exam.

FDA OTC Devices

AliveCor’s Smartphone-Linked ECG First Product Assessed Under UK’s Rapid HTA Pilot

NICE’s recently launched early value assessment (EVA) pilot has hit a milestone this month, with AliveCor’s KardiaMobile 6L the first product to be given the go-ahead for NHS use in England under the scheme.

Cardiology Medical Device

Vibrant IVDs Innovation Climate At Risk From Poor UK Regulatory System Readiness

The spotlight is on IVDs in the post-COVID phase. Innovators in university spin-outs and the established industry have responded with new technologies, creating a vibrant scene. Regulators and reimbursors must not disrupt the momentum, say BIVDA’s regulatory affairs manager Ashleigh Batchen and chief executive Doris-Ann Williams.

United Kingdom Regulation

Senate Proposes Smaller Boost Than House For FDA FY2023 Appropriation

A  proposed budget from the US Senate appropriations committee would fund the FDA's device activities at $663m for fiscal 2023, marking a modest increase from 2022 but a drop from House and administration requests. 

Policy Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

US FDA Adds More MDRs To Philips Recall, Including Deaths

The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.

FDA Recalls

Why EU Regulations Are Changing The Face Of Innovation And May Be Unsustainable

The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.

Europe EU

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

Commercial Explore this Topic

Set Alert for Commercial

Philips Announces CEO Succession In Midst Of Massive Recall

Philips CEO Frans van Houten will leave the company in October amid a massive recall of ventilators and related products. Roy Jakobs will succeed van Houten as CEO and president effective 15 October, Philips said.

Executive Changes Leadership Respiratory

Latest From Commercial

US FDA Adds More MDRs To Philips Recall, Including Deaths

The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.

FDA Recalls

Hear Ye! Hear Ye! Hearing Aids Coming To A Store Near You

The US FDA has finally established a new regulatory category for hearing aids that will allow Americans with mild to moderate hearing loss to purchase the devices directly over the counter without a prescription or prior exam.

FDA OTC Devices

De Oro Devices’ Nex(t)Stride To Help Freezing Gait Is Expand Into Other Diseases, Add Software

De Oro Devices’ plans to add more indications for its portable device for freezing gait associated with Parkinson’s disease. In 2023, the company hopes to address , multiple sclerosis, stroke and cerebral palsy, and add mobility-gait software.

Digital Health Neurology

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Acclarent Expects TruDi Shaver Blade To Prevent Repeat ENT Surgeries

The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.

Surgery Ear, Nose & Throat Innovation

Latest From Research & Development

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

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

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

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

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
UsernamePublicRestriction

Register