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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.

United Kingdom Policy Medical Device

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.

FDA Diversity & Inclusion Policy

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.

Europe EU Medtech Connect

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.

Regulation Recalls FDA

Spotlight On Meetings

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.

Leadership Digital Health Strategy

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.

Policy Telehealth Digital Health

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.

Executive Changes Commercial Medical Device

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Policy & Regulation Explore this Topic

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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.

Europe EU Artificial Intelligence

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.

Guidance Documents Regulation International

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.

Regulation Warning Letters

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.

Regulation FDA

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.

FDA Regulation

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.

Legal Issues Regulation

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.

Regulation Guidance Documents

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.

United Kingdom Regulation

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.

FDA Regulation

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. 

Policy Legal Issues

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.

Advertising, Marketing & Sales Clinical Trials

Commercial Explore this Topic

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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.

Patient Monitoring Drug Safety Platform Technologies

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.

Clinical Trials Platform Technologies

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.

Diagnostic Imaging Business Strategies

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.

Women's Health Digital Health

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.

Behavioral Health Digital Health

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.

Platform Technologies Cancer

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.

Minute Insights Approvals

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.

Minute Insights Approvals Clinical Trials

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.

Women's Health Digital Health

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.

Minute Insights Approvals

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.

Digital Health Artificial Intelligence

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.

Digital Health Cardiology

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.

Business Strategies Clinical Trials

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.

Digital Health Innovation
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