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UK Medtech Strategy Promises To Use Innovation Effectively And Build Resilience
The UK MedTech Directorate has issued its much-awaited medical technology strategy for improving supply resilience and encouraging innovative and dynamic markets and sector diversity.

Legal Expert Weighs In On New US Mandate To Diversify Clinical Trials
The omnibus spending bill passed at the end of 2022 requires clinical trial sponsors to submit a diversity action plan to the US Food and Drug Administration. Attorney Faraz Siddiqui, who coauthored a blog post on the new regulation, spoke to Medtech Insight about the requirement and the push to increase diversity.

Medtech Connect Episode 2: What Is The European Health Data Space?
In this episode of new podcast series Medtech Connect, Medtech Insight’s regulatory writer for Europe, Eliza Slawther, interviews Alexander Olbrechts, director for digital health at the European trade body MedTech Europe, to find out more about the proposed European Health Data Space initiative and what it means for the medical device industry.

News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.
Spotlight On Meetings
CES 2023: Tech Innovations For Simulated Heart Device Testing, Seizure Prediction, And Guiding The Visually Impaired
In this second roundup of innovative health solutions showcased at CES 2023, Medtech Insight highlights SK Biopharmaceuticals’ new wearables in development for early detection of seizures, Dassault Systèmes’ simulated 3D heart, and Lighthouse Tech’s eyewear to help the visually impaired detect obstacles.
JPM 2023: Boston Scientific Sees Transformational Potential In PFA, BD Sticks To '2025' Investment Strategy
JPM 2023: Novocure Announces Trial Results; ResMed Expands Manufacturing; Abbott's IVD Bet Pays Off
CES 2023: Abbott, Seth Rogen, An Avatar For Old Folks, And A Smart Toilet For The Heartbroken
UPDATED: JPM 2023: Baxter, Medtronic Pursue Simplification As Path To Growth
Axogen, Dario Health, Biobeat, Immunexpress All Weigh In On 2022 And What Will Succeed In 2023
Medtech Insight was invited to ask questions at a roundtable event organized by Russo Partners to review the major medtech industry trends of 2022 and what to expect in 2023.

Easier Access To Funding: FCC Rural Health Care Program Seeks Comments On New Actions
The Federal Communications Commission recently approved four proposals and seeks comments on four others to increase telemedicine access for rural communities.

Execs On The Move, January 2023: Spun-Off GE Healthcare Names Board, Officers
An interactive view of medtech executive changes from the month of January 2023, including GE Healthcare's new leadership as a standalone company.
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EU Regulatory Round-Up, January 2023: Cautious Optimism As New MDR Proposal Unveiled
All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.

Global Medtech Guidance Tracker: January 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-eight documents have been posted on the tracker since its last update.
Latest From Policy & Regulation
Warning Letter Close-Outs – January 2023
The US FDA released only one device-related close-out letters in January which went to a Michigan orthopedics firm.
Warning Letter Roundup & Recap – January 2023
The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.
What We Have Here Is A Failure To Communicate
ECRI says gaps in communication about recalls of medical devices used at homes pose a significant risk to patients. The nonprofit safety organization’s list of the top ten technology hazards for 2023 put lack of communication at the top.
Sotera Health Class Action Suit: Executives ‘Misled Investors’ During Public Offerings
Following Sterigenic’s $408m EtO settlement, a securities class action lawsuit has been filed against its parent company Sotera Health Company.
Q&A Guidance Document Discusses Laser Product How-Tos
Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.
UK MHRA’s New And Increased Medtech Fees In Force in April
One outcome of last year’s public consultation on UK MHRA fees is a hefty uplift in charges payable by medtech manufacturers in 2023, beyond which the agency is keen to pursue a new fees and charges plan.
Quality Control & Compliance Explore this Topic
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Latest From Quality Control
Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report
After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.
Product Liability Missteps Top List Of Worst Legal Verdicts Of 2022
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.
Expert: FTC Clinical Data Requirements A Likely Challenge For Medtech Companies
Medtech Insight spoke to Sidley Austin LLP partner Jeff Senger about the challenges companies may face navigating the FTC’s updated health products guidance.
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Pneumowave Breathes Easier In Its Fight Against Opioid Deaths After Completing £7.5m Raise
The Glasgow-based company has completed a large series A round to further develop its technology, which can be used to help save patients’ lives in the event of opioid overdose. Medtech Insight spoke to the Scottish National Investment Bank, one of the main investors, about the deal and its altruistic view of investment.
Latest From Commercial
Talking Trials, Investment And Fluid-Overload Treatments With Sequana Medical
Sequana Medical is simultaneously developing both drug and device treatments for fluid overloads in the body. Medtech Insight spoke to the company’s CEO about their trials and the challenges of raising cash in 2023.
Philips Healthcare Doubles Down On Creating An Agile Future
After an admittedly difficult 2022 for a variety of reasons, Philips Healthcare is ready to tackle 2023 and beyond by reducing business complexities, slimming staff numbers further and crucially implementing a new value creation strategy under recently appointed CEO Roy Jakobs.
Women’s Health Expert Panel Addresses Challenges, Opportunities In Post-Roe Era
After years of underfunding, stigmatization and lack of research, companies working on products and services that address women’s health care are gaining traction. But the sector also faces unique challenges, such as gaining approval for ads on major social media platforms.
The Serious Business Of Digital Medical Games
There are fewer than a handful of prescription video game digital therapeutics with regulatory clearance, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.
Contrast Agent, Liquid Biopsy Tool Or Treatment? Earli Might Deliver All Three At Once
The company has developed a technology that uses engineered DNA to reprogram cancer cells, forcing them to produce substances that could be used to help image, detect or even destroy them.
Minute Insight: Abbott Wins Expanded FDA Approval For Proclaim XR Spinal Cord Stimulator For Diabetic Peripheral Neuropathy
Abbott said a major competitive benefit of the Proclaim XR SCS system is the battery life of up to 10 years at low settings.
Clinical R&D Explore this Topic
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Minute Insight: Abbott Rolls Out Navitor Next-Gen TAVR System To Catch Up To Medtronic And Edwards
Navitor is an upgraded version of Abbott’s Portico TAVR system with a better fabric cuff and large curved aortic “cells” to reduce the risk of injury to the native valve.
Latest From Research & Development
Women’s Health Expert Panel Addresses Challenges, Opportunities In Post-Roe Era
After years of underfunding, stigmatization and lack of research, companies working on products and services that address women’s health care are gaining traction. But the sector also faces unique challenges, such as gaining approval for ads on major social media platforms.
Minute Insight: Abbott Wins Expanded FDA Approval For Proclaim XR Spinal Cord Stimulator For Diabetic Peripheral Neuropathy
Abbott said a major competitive benefit of the Proclaim XR SCS system is the battery life of up to 10 years at low settings.
Digital Health Roundup: CES 2023 Highlights; US FDA VR, AR Website; Bayer’s Powers Up On Radiology
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.
CES 2023: Competition Spikes In Cuffless Blood Pressure Monitoring
In this final roundup of innovative health technologies showcased at CES 2023, Medtech Insight highlights three companies, Biobeat, Conneqt and Valencell, that are developing innovative technologies for cuffless blood pressure monitoring. Biobeat is the first company to receive US FDA clearance for a wearable to monitor blood pressure, but competition looms.
Shockwave Buys Neovasc, Hoping Reducer Angina Device Complements Coronary Lithotripsy
Shockwave, which markets lithotripsy technology to treat calcified vascular disease, will pay about $100m upfront and up to $47m more in potential milestones to buy Neovasc, the Vancouver, BC-based developer of the Reducer device to treat angina.
CES 2023: Tech Innovations For Simulated Heart Device Testing, Seizure Prediction, And Guiding The Visually Impaired
In this second roundup of innovative health solutions showcased at CES 2023, Medtech Insight highlights SK Biopharmaceuticals’ new wearables in development for early detection of seizures, Dassault Systèmes’ simulated 3D heart, and Lighthouse Tech’s eyewear to help the visually impaired detect obstacles.
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