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Featured Stories

Lux Capital’s Deena Shakir Bullish On Women’s Health: ‘Fundamentally A Massive Market Opportunity’

Medtech Insight talked with Lux Capital’s general partner Deena Shakir about her investments in women’s health, untapped opportunities and barriers, gender equality in investment, and her outlook for investment in women’s health.

Exec Chats Women's Health Digital Health

EU Opening Pandora’s Box With Data Act, Warns Medical Imaging Body COCIR

Medtech trade body COCIR has joined forces with representatives from industries within and outside health care to warn that the European Commission’s proposed EU Data Act is a “huge leap into the unknown.”

Europe EU Digital Health

Former Oracle Exec Joins FDA As Director Of Digital Health Center Of Excellence

Former Oracle cloud expert Troy Tazbaz brings cloud computing expertise to his new role as director of the Food and Drug Administration’s Digital Health Center of Excellence (DHCOE).

FDA Digital Health Regulation

Minute Insight: J&J Monarch Robot Removes Kidney Stone With Mini-PCNL Procedure

The company is sponsoring the first clinical study of robotically assisted electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy – kidney stone removal – with the Monarch robotic-assisted platform for urology.

Minute Insights Clinical Trials Approvals

Spotlight On Meetings

Novel Models Of Care Must Feature In Updated UK NHS Plan

COVID has necessitated a refresh of NHS England’s Long Term Plan, which must double down on concepts such as at-home, patient-empowered care and virtual wards, says the NHS Confederation.

United Kingdom Policy Medical Device

Reporting At-Home COVID-19 Diagnostics Just Got Easier; FDA Encourages Sharing The Results

The US Food and Drug Administration has released new information about reporting the results of over-the-counter (OTC) at-home COVID-19 antigen tests, as well as recommendations on who should get tested, when, and how often.

FDA Policy Coronavirus COVID-19

AI Medical Technology Doubles Down On Melanoma With Trials And Financing

Over the past month, the company has released positive clinical trial results and raised more cash, both of which will help on its way to combat melanoma.

Clinical Trials Financing Innovation

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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

SME Success: How Eyenuk Traversed ’Stringent’ EU MDR For AI Eye Screening System

The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.

Diagnostic Imaging Ophthalmology

North Carolina Doctor Convicted For Reusing Sinus Surgery Devices

The ENT specialist reportedly purchased only 36 single-use sinus devices but performed at least 1,400 procedures. She could land up to 40 years in prison after being convicted on 20 counts including device adulteration, conspiracy, and fabricating medical records. 

Policy Legal Issues

Reducing Antimicrobial Resistance With Rapid Tests

Widespread implementation of rapid diagnostic tests is critical for decreasing antimicrobial resistance. 

Diagnostics Regulation

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

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

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

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

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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 Commercial

Latest From Commercial

SME Success: How Eyenuk Traversed ’Stringent’ EU MDR For AI Eye Screening System

The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.

Diagnostic Imaging Ophthalmology

Reducing Antimicrobial Resistance With Rapid Tests

Widespread implementation of rapid diagnostic tests is critical for decreasing antimicrobial resistance. 

Diagnostics Regulation

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

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

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

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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 Behavioral Health

Latest From Research & Development

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

JPM 2023: Boston Scientific Sees Transformational Potential In PFA, BD Sticks To '2025' Investment Strategy

The annual J.P. Morgan Healthcare Conference includes presentations from major medtech companies; Some use the conference as a platform for major announcements while some just take the opportunity to explain their 2023 outlook to investors. Here are some of the highlights from the presentations on the third day of the meeting.

Business Strategies Restructuring
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