Featured Stories

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.

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.

“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.

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.
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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Medtech Insight Podcasts
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Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging TechnologiesListen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
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Global Device Regulation

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.

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.
Digital Health

‘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.”

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.

Akili Awaits FDA Feedback On Data Needs For OTC Marketing Of ADHD Digital Therapeutic
The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.
Interviews

“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.

Octave Biosciences Takes It Up Another Semitone With Michael J Fox Foundation Grant
The diagnostics company has secured $10m from the foundation to develop a biomarker test for Parkinson’s disease.
Podcasts

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.
Recent Stories

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.

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.

EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink
There is currently a melting pot of ideas concerning the future of the EU’s medtech regulatory system due to its shortfalls. All the while progress is being made, especially in the area notified bodies.

News We’re Watching: New AF Guidelines, Nevro Buys Vyrsa, LivaNova Responds To Cyberattack
Medtech Insight's News We're Watching highlights medtech industry news developments you may have missed over the last few weeks. Last week, cardiologists got new guidelines for managing patients with atrial fibrillation and Nevro made a big move to expand beyond its core spinal cord stimulation business.

German-Speaking European Associations Collaborate To Focus On Medtech’s Needs
Three central European industry associations have agreed to develop joint initiatives and form a collective voice with which to lobby decision-makers on medtech themes of mutual interest.

US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner
When Janet Woodcock retires early next year, Namandjé Bumpus will take over as No. 2 in command at the FDA. Since joining the agency in 2022 from Johns Hopkins, her profolio has included health disparities, cosmetics, and drug review disputes.

News We’re Watching: Biden Moves To Strengthen Supply Chain; More Medtech-Related Prosecutions; $5.5M Sepsis Grant For Siemens
This week, the Biden administration announced a new council on supply chain resilience that includes health care goals; an apparent enforcement surge against device fraud continued; Siemens won a $5.5m grant to develop a better sepsis test; and the FDA proposed new classifications for wound care products.

FDA Receives Thousands Of Opinions On Proposal To Regulate LDTs As Comment Period Comes To A Close
As the US FDA works to finalize new regulation of lab-developed tests, it must consider more than two thousand comments that have poured into the agency since the proposed rule was published in October. The comment period closes Monday.
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