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Government Investment Pays Off: Cue Health Gets EUA For At-Home OTC COVID-19 Test

After the US government invested almost half a billion dollars to ensure Cue Health could scale up production, the FDA announced the self-administered test will now be available over the counter.

Regulation Commercial Policy

Q&A: New Standard For Device Irritation Nudges Industry Away From Animal Testing – And Toward Tests On Lab-Made Human Skin

An ISO-recognized expert tells Medtech Insight why international standard ISO 10993-23:2021 urges irritation testing on laboratory-grown skin – also known as in vitro reconstructed human epidermis (RhE) – and why device makers will like it.

International Standards Clinical Trials

Colfax Plans To Split To Form Separate Medtech And Fabtech Companies

The yet-to-be-named medtech company will focus on orthopedic implants and bracing and recovery devices.

M & A Business Strategies Orthopedics

BioVentrix Continues Battle To Remodel Post-Attack Hearts

Following reimbursement approval in Germany, BioVentrix is making headway in long-neglected post-heart attack treatments.

Reimbursement Clinical Trials Cardiovascular

UK Can Set The Pace In Ending Late Stage Disease Diagnosis, Says Cancer Charity

Earlier detection of cancer can only happen with a concerted, government led effort, more investment and cross industry collaboration, says CRUK. Its Roadmap to the Future sets out the milestones for achieving that aim.

Diagnostics Cancer Medical Device

Execs On The Move: Activity In Board Rolls As AxoGen, Alafair, InfuSystem And Others Appoint New CEOs

Alongside a number of chief executive officer appointments, companies such as Endotronix, TruScreen, Glaukos, and others have appointed new board members. AxoGen and Acutus announced new chief financial officers.

Appointments Commercial Companies

Device Week, 5 March 2021 – Remote Monitoring Reimbursement, T-cell Diagnostics, And A Digital Health Feature

In this week's podcast, managing editor Marion Webb discusses a new monthly digital health roundup which will soon feature on Medtech Insight. Managing editor Reed Miller discusses reimbursement difficulties as it applies to remote cardiac monitoring. UK-based reporter Barnaby Pickering gives an overview of an interview with the chief medical officer of Adaptive Biotechnologies about its new T-Detect platform.

Device Week Digital Health Research & Development

Device Week Podcast




Discussed in this episode:


Securing FDA Approval For Novel OPRA Prosthetic Wasn’t A ‘Slam Dunk.’ Here’s How Start-Up Integrum Made It Through The PMA Maze

In this case study, experts at the law firm Hogan Lovells and device maker Integrum AB tell Medtech Insight about some hurdles the Swedish start-up ju...

Review Pathway Approvals

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Policy & Regulation Explore this Topic

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COVID-19: Test Developers Focus On New Variants

Researchers discussed ways to ensure COVID-19 diagnostics work for all variants during a recent webinar.

International Coronavirus COVID-19 Diagnostics

Global Medtech Guidance Tracker: February 2021

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

International Australia Canada

Latest From Policy & Regulation

FDA Warns Against Misuse Of Thermal Imaging Systems

The devices may be less accurate when used to screen multiple people at once, the US agency says.

Safety Enforcement

Clue Faces Competitor Scrutiny On Entry Into Birth Control App Space

The US Food and Drug Administration has cleared Clue as the second app with a birth control indication to reach market – but the first company on the scene questions whether it's as effective as theirs.

Regulation Gynecology & Urology

FDA Launches Digital Modernization Plan To Complement Its Technology Modernization Plan

Agency heads say the new plan will siphon and aggregate more data that could help the regulatory body make better and faster regulatory decisions.

Regulation Policy

Stalemate Over Virtual Audits In EU As Commission Tells TEAM-NB To Back Off

Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.

Europe EU

Medtech SMEs See Opportunities In UK Budget Of Few Surprises

Schemes and funding to support growth in the life sciences and medtech sectors featured in the UK government’s spring budget on 3 March.

Financing Innovation

FDA Scolds Firms For Claims That Could Mislead The Public About COVID-19 Products

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

Regulation Commercial

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Stalemate Over Virtual Audits In EU As Commission Tells TEAM-NB To Back Off

Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.

Europe EU

FDA Scolds Firms For Claims That Could Mislead The Public About COVID-19 Products

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

Regulation Commercial

US Regulatory Roundup, February 2021: QA/RA Predictions, FDA Warning Letter Stats, PMA Case Study, And More

Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.

United States Regulation

OUTLOOK 2021 IS LIVE

Access In Vivo’s annual showcase of special features and industry league tables, including Scrip 100

VIEW 2021 RANKINGS

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Tyto Care Raises $50M In Series D To Expand Telehealth Platform

Tyto Care will use the proceeds to expand its telehealth and remote monitoring solution to the US, Europe, and Asia, and add AI capabilities.   

Telehealth Artificial Intelligence Financing

Latest From Commercial

Reimbursement Questions Jeopardize Hillrom/Bardy Merger

Hillrom is reconsidering its planned $375m acquisition of Bardy Diagnostics because of Novitas' plan to cut Medicare reimbursement for extended cardiac monitoring. Bardy is suing to complete the deal.

Legal Issues M & A

Boston Scientific Pays More Than $1Bn For Lumenis’ Surgical Laser Business

Lumenis’ surgical business includes the MOSES laser system for minimally invasive urology surgery which will complement Boston Scientific’s LithoVue ureteroscope.

M & A Gynecology & Urology

FDA Scolds Firms For Claims That Could Mislead The Public About COVID-19 Products

The agency says it has sent letters to dozens of companies that have made ‘FDA Registration Certificate’ claims or used the agency’s logo without authorization, which could lead customers to think the products have been vetted.

Regulation Commercial

Digital Health Roundup, January/February 2021: The Continued Rise Of AI, Telehealth

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from the year so far. 

Digital Health Telehealth

More IVD Mergers: Agilent Buys Resolution, Hologic Acquires Diagenode

Hologic made its third big acquisition of 2021 and Agilent agreed to pay up to $695m for Resolution Bioscience to extend its precision oncology capabilities.

M & A Cancer

Q&A: Device Industry Attorney Talks Mass Tort Strategy, Pitfalls

Medtech Insight spoke to attorney Greg Dadika about mass tort litigation, including industry trends, how to find the right law firm, and when it’s the right time to settle a suit.

Commercial Legal Issues

Clinical R&D Explore this Topic

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Exec Chat: Adaptive Biotechnologies Will Use T Cells To Spot Prior Infections, Including COVID-19

Adaptive chief medical officer Lance Baldo talked to Medtech Insight about the company's plans to detect prior infection using T-cells obtained from blood samples.

Coronavirus COVID-19 Diagnostics Exec Chat

Latest From Research & Development

Digital Health Roundup, January/February 2021: The Continued Rise Of AI, Telehealth

In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from the year so far. 

Digital Health Telehealth

Sensyne Algorithm For COVID-19 Risk Prediction Gets UK Regulatory Approval

Sensyne obtained UK regulatory approval for its SYNE-COV machine learning algorithm to assess the long-term risks of COVID-19.

Digital Health Approvals

Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic

On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.

Device Week FDA

NuVasive Adds Artificial Cervical Disc By Acquiring Simplify For $150M

Simplify’s total disc replacement complements NuVasive’s C360 line of cervical repair surgery devices, addressing a market that could eventually be worth $2.6bn.

M & A Orthopedics

Medtronic Claims Share Gains In Cardiovascular And Neurostim

The company’s revenue was down just 1% year-over-year in the third quarter of fiscal 2021, despite the ongoing impact of the pandemic.

Sales & Earnings Business Strategies

Trial Shows Lateral Flow Antibody Testing Could Be Used To Assess COVID-19 Vaccine Efficacy

Abingdon Health has announced that a study run in conjunction with the UK Rapid Test Consortium has demonstrated that its AbC-19 test could be an effective tool for testing vaccine efficacy.

Diagnostics Clinical Trials
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