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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.

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.

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.

‘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.
Spotlight On Agetech
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.

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.

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New draft guidance from the US agency calls for manufacturers to add more information about potential risks to the labeling of some types of contact lens solution.

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.
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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.

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.
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.
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.
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.
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.
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.
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.
Quality Control & Compliance Explore this Topic
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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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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