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

Diagnostics Reform Reintroduced in House

The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.

Diagnostics Policy Politics

EU Regulatory Round-Up, March 2023: EU Deadlines Under MDR Amending Regulation Published And Clarified

This month’s round-up summarises the biggest EU medtech regulatory news in a year as legacy device transition periods are extended. A highly applauded commission summary of the new timelines under the EU’s MDR amending regulation provides key snapshot of the essential points.

Europe EU Medical Device

Minute Insight: Xeltis Expects The US Trial Of 'Living' Vascular Graft To Start This Year

Xeltis hemodialysis access graft, made of its proprietary electrospun supramolecular polymer material, is advancing in clinical trials in Europe and will likely be ready for a US trial by the end of this year, according to the company.

Minute Insights Clinical Trials Diabetic Care

News We’re Watching: SALSA Reintroduced, FDA Approves Abbott Valve, Metallic Implant Study

A bill aimed at preventing laboratory reimbursement cuts has been reintroduced in the US Congress. Additionally, an Abbott valve landed FDA approval, On Target Labs reported trial results, and the FDA warned that dental palate expanders may pose health risks to adults.

Commercial Regulation Safety

Global Medtech Guidance Tracker: March 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four documents have been posted on the tracker since its last update.

Guidance Documents Regulation International

HHS Watchdog Blesses Proposed Gift Card Giveaway To Encourage Test Returns

A proposal that would give some patients gift cards in exchange for returning a screening test sample would not violate anti-kickback law because it doesn’t encourage medically unnecessary services, HHS-OIG says.

Compliance Legal Issues Policy

UK Updates Guidance To Reflect EU Medtech Extensions - Pledges Focus On Agility, Innovation

The EU’s decision to extend the Medical Device Regulation transition periods for legacy medical device directives products will be mirrored in the UK, which also continues to evolve its post-Brexit medtech regulatory system.

United Kingdom Regulation Medical Device

Medtech Insight Podcasts

This Episode:

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
 



Medtech Insight Tweets

Latest from PR Newswire

Click here to access further medical device and diagnostics news.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions

The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.

FDA Guidance Documents Coronavirus COVID-19

EU MDR Extended Transitions: Practical Advice From Commission

Concerns and uncertainties arising among manufacturers following the recent extension of the MDR's transition periods have been addressed in a question-and-answer document issued by the European Commission.

EU Regulation Medical Device

Latest From Policy & Regulation

Switzerland’s Swift Reaction To MDR’s Extended Transitions Keeps EU Equivalency

The medtech regulatory authorities in Switzerland have pledged to follow the EU’s lead in granting extended transition periods for legacy devices under the MDR.

Switzerland Regulation

‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October

The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.

Cybersecurity Regulation

Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move

The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.

EU Europe

FDA Issues Framework For Use Of Digital Health Technologies In Drug Development

The FDA’s new framework for the use of digital health technologies will engage stakeholders to provide more guidelines for the industry.

Digital Health Policy

Pivotal Opportunity For UK Medtech Must Not Be Wasted

The UK continues to work on its new medtech regulatory system and market access processes for innovations, but all the planning and preparations will count for little if not accompanied by sound execution, warns Lincoln Tsang of law firm Ropes & Gray.

United Kingdom Regulation

FDA's Updated Draft Animal Testing Guidance Clarifies Its Scope

The US FDA’s guidance document on animal testing for medical devices clarifies the scope of a document issued in 2016.

FDA Guidance Documents

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October

The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.

Cybersecurity Regulation

Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move

The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.

EU Europe

FDA's Updated Draft Animal Testing Guidance Clarifies Its Scope

The US FDA’s guidance document on animal testing for medical devices clarifies the scope of a document issued in 2016.

FDA Guidance Documents

Commercial Explore this Topic

Set Alert for Commercial

How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance

UTIs are one of the most common reasons for antibiotics to be prescribed, but accurate and timely diagnostic tools are lacking. England’s NICE has identified four innovative IVDs that could be rolled out for NHS patients, but said more research is needed on these products first.

Europe EU United Kingdom

Latest From Commercial

LSI 2023: Intuitive Alums On Dawning Of Robotic Surgery To Digital OR Future

Robotic surgery pioneer and co-founder of Intuitive Surgical Frederic Moll joined Daniel Hawkins, Intuitive’s first non-technical hire, for a discussion on the evolution of surgical robotics and outlook for the future.

Robotic Surgery Innovation

Podcast Special: J&J's Andrie Leday Addresses ASC Market With Customized Approach

In this special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes' broad range of orthopedic implants and tools to meet the demand of an aging population.

Artificial Intelligence Business Strategies

LSI 2023: What Ophthalmology Start-Ups Pitched To Investors At Emerging Medtech Summit

Leaders of burgeoning ophthalmology companies pitched innovations for treating glaucoma, macular degeneration and corneal blindness to potential investors and partners at the LSI Emerging Medtech Summit in Dana Point, CA. Here’s what Medtech Insight heard and learned in on-site interviews with chief executives.

Ophthalmic Ophthalmology

News We’re Watching – US FDA Updates, Digital Therapeutics Legislation, AI Endoscopies, Monkeypox EUA, And New AdvaMed Chair

The US Food and Drug Administration recently issued updates regarding improvements to its online submissions portal, enhancements to its electronic medical device reporting system, pediatric X-ray guidance, expanded indications for a popular breathing device, and mammogram guidelines; and more news we’re watching.

FDA Regulation

Cardio Catch-Up: Medtronic, Abbott, Ancora Devices Headline ACC, CRT, THT

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition focuses on clinical trial presentations from three recent conferences: American College of Cardiology in New Orleans, Cardiovascular Research Technologies in Washington, DC, and Technology and Heart Failure Therapeutics in Boston.

Commercial Clinical Trials

Is Time Nearly Up For Pear? The PDT Company Could Be Bargain For Acquirer

Despite earlier efforts to restructure, the company is still struggling to meet its revenue targets, and issued a statement suggesting that further measures, including liquidation, may be necessary.

Financing Digital Health

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Getting Personal With Brittany Barreto: From One-Time ‘Science Hater’ To Genetics Doctorate, DNA Dating App And Women’s Health Champion

Medtech Insight sat down with Brittany Barreto, CEO of FemHealth Insights, who participated in a panel discussion at SXSW 2023 on the $1t femtech industry, to talk about her journey to becoming a women’s health care champion.

Exec Chats Women's Health Artificial Intelligence

Latest From Research & Development

Podcast Special: J&J's Andrie Leday Addresses ASC Market With Customized Approach

In this special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes' broad range of orthopedic implants and tools to meet the demand of an aging population.

Artificial Intelligence Business Strategies

Medtronic Earns CE Mark For Affera Ablation System, Touts New PFA Results

Results of the PULSED AF trial confirm that Medtronic’s PulseSelect pulsed field ablation is safe and effective for atrial fibrillation ablation. The company will likely incorporate PulseSelect into its Affera cardiac mapping and ablation system, which will soon be available in Europe.

Approvals Clinical Trials

Harbinger Health CEO Stephen Hahn On Early Cancer Detection To ‘Move The Needle’ On Survival

Medtech Insight spoke with Stephen Hahn, ex-FDA commissioner and CEO of Harbinger Health, who attended SXSW, about the firm’s blood-based cancer test in development.

Exec Chats Cancer

Increase Access To MedTech: AdvaMed’s Priorities For The 118th Congress

AdvaMed’s Medical Innovation Agenda for the 118th Congress emphasizes increased access to medical devices, from reimbursement for breakthrough devices to boosting America’s start-ups to closing the care disparities for underserved communities.

Policy Reimbursement

Digital Health Roundup: Omar Ishrak’s SPAC; AI In Dermatology, IVF, Imaging; Wellness Apps And Trust

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights how Alife Health is using its AI-based platform for IVF to increase chances for successful pregnancies while Barnaby Pickering discusses how AI Medical Technology is using AI to detect melanoma. Reed Miller talks about weight-loss device maker Allurion Technologies’ signed SPAC deal.

Digital Health Artificial Intelligence

FDA Clears Abbott’s Modified CGM For Automated Insulin Delivery Integration, Label Expansion

Abbott announced today it plans to integrate its FDA-cleared modified CGMs with insulin pump makers, including Tandem and Insulet, likely later this year.

FDA Approvals
UsernamePublicRestriction

Register