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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.

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.

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.

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.
Spotlight On Cardiovascular Technology
France’s Snitem Demands Shock Cardiac Devices Reimbursement Decision Be Reversed
French medtech trade association, Snitem, and local cardiologists are stunned by the removal from the reimbursement list of two state-of-the art cardiology devices and are demanding their reinstatement.
Cardio Conversations: Abbott Aspires To Build 'Future Ready' CRM Devices
Reimbursement For Shockwave’s IVL Device May Pose Quandary For CMS
Cardio Conversations: Abbott's Electrophysiology CMO Christopher Piorkowski On Cardiac Mapping, PFA, VT And More
Getting Personal With Boston Scientific's Global CMO Ken Stein: Taking The Long View To Innovate, Serve Patients

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.

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.

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.
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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.

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