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Advocates Ask Medicare To Reverse Transplant Patient Test Payment Policy
A recent Capitol Hill event drew speakers such as Newt Gingrich, Sen. Kirsten Gillibrand, and musician Al B. Sure to protest a Medicare contractor’s decision to restrict coverage of blood tests used to detect early signs of rejection or organ damage in transplant patients.

Medtronic Is Not Going With The EOFlow – Deal Cancelled
Medtronic is dropping plans to acquire EOFlow, which has faced numerous patent lawsuits from Insulet.

23andMe Data Breach Larger Than Previously Reported
The numbers for the genetic testing company’s October data breach are much larger than previously reported, and now the company might be trying to shield itself from class action lawsuits.

Edwards Plans To Boost Growth By Spinning Off Critical Care Unit In 2024
The critical care business is developing smart-recovery products integrated into Edwards’ HemoSphere monitoring platform. The company expects the tax-free transaction will help the new company advance patient monitoring technology and let Edwards focus on its structural heart technologies.
Spotlight On Medtech Meetings
Israeli Medtech Leaders Say War Is Impacting Companies, Driving Industry Humanitarian Effort
Two executives of Israeli-based medtech companies say the Hamas-Israeli war is having an impact on their companies, with employees being called up as reservists and others needing accommodations. It also has galvanized companies to join forces to support health and humanitarian needs during the crisis.
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Opinion: At Least It’s Not Fruitcake – My Annual FDA Predictions
Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year.

EU Lists Its First Reference Laboratories For High-Risk IVDs Falling Into Class D
There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.

German Medtechs Search For Blue Skies Amid ‘Cloudy Outlook’ For Industry − Medica 2023
While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.

Mosie Baby First To Win FDA Clearance For At-Home Artificial Insemination Kit
Austin-based start-up Mosie received FDA clearance for a home insemination kit to help people get pregnant. The kit retails for $129.99.

Opinion: At Least It’s Not Fruitcake – My Annual FDA Predictions
Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year.

MDR Changes Aren’t A ‘Catalyst’ For Medtech Investments In Ireland
IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech.

‘One Little Cog’: Former J&J Attorney Discusses Return To Private Practice
In this wide-ranging interview, lawyer Philip Desjardins talks about regulatory issues from AI to LDTs – as well as the passion for patient health that keeps him in the medtech arena.

AMA Establishes Principles For ‘Augmented Intelligence’
The American Medical Association has written a set of principles for augmented intelligence (AI) development and deployment in health care. The organization hopes these principles can shape “a consistent governance structure for advancements in health care technology.”

Q&A: The “Secret Sauce” Of Sofinnova’s New AI-Based Investment Platform
The venture group has debuted Sofinova.AI, a software platform capable of viewing a potential investment in much more detail than a human.

German Medtechs Search For Blue Skies Amid ‘Cloudy Outlook’ For Industry − Medica 2023
While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.

“We’re A Pain-Management Company.” Nevro Adds SI Joint Surgery To SCS Business
Nevro is known for its spinal cord stimulation technology but wants to help a wide range of patients with chronic pain, so it is buying Vyrsa, which offers a complete system for sacroiliac joint fusion. In and interview with Medtech Insight, Nevro CEO Kevin Thornal explained how Vyrsa supports Nevro's strategy in this growing market.

MDR Changes Aren’t A ‘Catalyst’ For Medtech Investments In Ireland
IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech.

Digital Health Roundup: Black Friday Hits – Digital Twins, Biowearables, Robotics, Cardiology
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

Digital Health Roundup: HLTH, LSX, AdvaMed; FDA And Pre-Determined Change Control Plans
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.

Podcast: The Realities Of Real-World Evidence
In this special podcast, Medtech Insight managing editor Elizabeth Orr talks to consultant Steve Silverman about the FDA’s current position on real-world evidence and real-world data, as well as how manufacturers can best put the evidence types to use.

Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging Technologies
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

Opinion: At Least It’s Not Fruitcake – My Annual FDA Predictions
Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year.

Q&A: The “Secret Sauce” Of Sofinnova’s New AI-Based Investment Platform
The venture group has debuted Sofinova.AI, a software platform capable of viewing a potential investment in much more detail than a human.

EU Lists Its First Reference Laboratories For High-Risk IVDs Falling Into Class D
There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.

German Medtechs Search For Blue Skies Amid ‘Cloudy Outlook’ For Industry − Medica 2023
While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.

Mosie Baby First To Win FDA Clearance For At-Home Artificial Insemination Kit
Austin-based start-up Mosie received FDA clearance for a home insemination kit to help people get pregnant. The kit retails for $129.99.

“We’re A Pain-Management Company.” Nevro Adds SI Joint Surgery To SCS Business
Nevro is known for its spinal cord stimulation technology but wants to help a wide range of patients with chronic pain, so it is buying Vyrsa, which offers a complete system for sacroiliac joint fusion. In and interview with Medtech Insight, Nevro CEO Kevin Thornal explained how Vyrsa supports Nevro's strategy in this growing market.

MDR Changes Aren’t A ‘Catalyst’ For Medtech Investments In Ireland
IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech.

eSTAR Now Open For PMA Submissions
The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.

FDA Evaluating Safety Of Plastic Syringes From China, May Prevent Their Import To The US
The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.

Global Medtech Guidance Tracker: November 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

European Health Data Space Regulation: Hurdles Ahead As Negotiations Intensify
As the European Health Data Space Regulation heads towards a more intense discussion phase, EU member states still have concerns over patient data autonomy, data storage, and resources for developing national health data platforms.

Seeing The Wood From The Shrubs: Azalea Begins Tests Of Its Smart Contact Lens
The Belgian start-up is developing a scleral contact lens with an inbuilt LCD screen capable of filtering light – offering a non-surgical solution to a variety of ophthalmic conditions.
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