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Featured Stories

Liquid Biopsy Revolutionizing Cancer Care, But Costs Continue To Inhibit Global Potential

Liquid biopsy represents potential advantages over traditional approaches to cancer surveillance, treatment selection and recurrence monitoring. But one size does not fit all, requiring tailored solutions for less developed markets.

In Vitro Diagnostics Cancer Innovation

FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices

In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.

FDA Guidance Documents Policy

Industry Welcomes Changes To EU AI Act, But Fears Of Overlap Remain

While recently proposed amendments to the draft EU legislation on Artificial Intelligence are a step in the right direction for medical devices, trade associations MedTech Europe and COCIR warn that the potential for regulatory conflicts remains.

Europe EU Artificial Intelligence

Minute Insight: Indigo Diabetes Starts Human Trial Of Subcutaneous Glucose Monitor

The company has enrolled the first patient in the second human trial of its implantable metabolite monitoring system, which it expects could change the game for blood glucose measurement.

Minute Insights Diabetic Care Clinical Trials

Spotlight On EU Regulation

How MDR’s Clinical Investigation Rules Could Drive Some Spinal Fusion Products Out Of EU

The new EU Medical Device Regulation has introduced stricter clinical evidence requirements for many products. But is it even feasible to generate this data for certain legacy devices, such as those used in spinal fusion surgeries, and which products are likely to fall into the high-risk category?

Europe EU

FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs

As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.

FDA Policy Coronavirus COVID-19

Esper Bionics Is Creating Prostheses That Think Before They Act

Start-up Esper Bionics has designed a prosthetic hand that can anticipate a user’s actions, changing the game for amputees.

Innovation Digital Health Ukraine

Investor Eye: SVB Speaks On Investment Slowdown, Securing An Exit, But Also Optimism

In a panel discussion at the TCT conference in Boston and in a recently published report, Jonathan Norris of Silicon Valley Bank explained why health care investment has slowed this year, and why remaining pragmatic and optimistic is important moving forward.

M & A Strategy Financing

Medtech Monthly Podcast

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

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Policy & Regulation Explore this Topic

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Novel Negative Pressure Wound Therapy System Cleared By FDA

The FDA granted 510(k) clearance to Applied Tissue Technologies for its non-foam negative pressure wound therapy system. 

Approvals Regulation FDA

FDA Issues Guidance To Protect Children Enrolled in Clinical Trials

The US FDA has published a draft guidance outlining its current thinking on ethical considerations for clinical trials of medical products, including devices, that enroll children.

FDA Pediatrics Policy

Latest From Policy & Regulation

Joint Mission: FDA And VA Partner On Device Development Initiative

The US Food and Drug Administration and the Veterans Health Administration are partnering to create tools that can help novel technology reach patients more quickly and easily.

FDA Policy

Industry View: EU Plans To Extend Product Liability Rules Bad News For Medtech

A proposed revision to the European Commission’s Product Liability Directive that will extend user compensation eligibility to products such as medical smartphone apps could “needlessly disrupt” innovation in the EU, trade group MedTech Europe warns.

EU Europe

CDC Chooses Five Laboratories For Pathogen Genomics Network

The CDC’s $90m funding will be split among five laborites across the US over five years as a part of its pioneering Pathogen Genomics Centers of Excellence Network.

Policy Coronavirus COVID-19

Minute Insight: Thermo Fisher Gets FDA OK On Cancer Companion Diagnostic

The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.

Minute Insights Personalized Medicine

EU Position Paper Outlines Notified Body View On Hybrid MDR/IVDR Audits

Hybrid audits of quality management systems (QMS) can satisfy certain requirements of new EU medtech regulations while improving efficiencies, TEAM-NB has said. In a new position paper, the association details how and when hybrid audits are appropriate.

Europe EU

Software Pre-Certification Program Highlights Needs For Legislative Change, FDA Says

In a report published September 26, the FDA released the findings from its software pre-certification program which include the need for a new regulatory authority to supplement current regulations for medical devices.

Legislation FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

Italy Establishes National Competencies Under Medical Device and IVD Regulations

EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.

Europe EU

French Government Will Tell Commission To Give Notified Bodies Time To Process All Files

Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.

Europe EU

Overdue Revision Of EU Cancer Screening Would Benefit Medtech Industry As Incidence Skyrockets

Council of the EU recommendations on cancer screening have not changed in some 20 years, yet the increase in cancer rates is alarming. Industry associations, COCIR and MedTech Europe have come out in support of the European Commission’s push for a revision.

Europe EU

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Minute Insight: Indigo Diabetes Starts Human Trial Of Subcutaneous Glucose Monitor

The company has enrolled the first patient in the second human trial of its implantable metabolite monitoring system, which it expects could change the game for blood glucose measurement.

Minute Insights Diabetic Care Clinical Trials

Latest From Commercial

Minute Insight: Thermo Fisher Gets FDA OK On Cancer Companion Diagnostic

The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.

Minute Insights Personalized Medicine

Minute Insight: Smith + Nephew Expands VR-based Surgical Training

Smith + Nephew is expanding its suite of simulation technologies to train surgeons on new techniques before they enter the operating room.

Minute Insights Orthopedics

TCT 2022: Edwards Ready To Take On Abbott In Mitral Repair Market With ‘Premium’ Device

Edwards Lifesciences is ramping up US commercialization of its Pascal Precision mitral valve transcatheter edge-to-edge repair device, the first US competitor for Abbott’s MitraClip. The FDA approved Pascal Precision earlier than the company expected, based on results of the CLASP IID trial.

Approvals Business Strategies

TCT 2022: Edwards' Pascal Matches Abbott's MitraClip In CLASP IID

Results of the CLASP IID trial showed Edwards’ Pascal mitral valve repair system was non-inferior for safety and effectiveness compared to Abbott’s MitraClip device.

Clinical Trials Cardiology

MedTech Europe’s 2022 Report: Germany Top For Medical Device And IVD Sales

MedTech Europe’s latest annual report unveils facts and figures that contextualize the European market against the global stage and highlight which countries are leading the way for medtech sales and employment.

Europe EU

BTIG Analyst Zooms Into Alcon’s Revamp Into ‘Building A Pharma Company Inside A Device Company’

In his recent report on Alcon, BTIG analyst Ryan Zimmerman estimated that its pharmaceutical portfolio could generate close to $900m in fiscal year 2022.

Ophthalmic Commercial Strategies

Clinical R&D Explore this Topic

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TCT 2022: Trial Of Boston Scientific’s TAVR Embolic Protector Misses Endpoint, But May Offer 'Hope'

New trial data shows Boston Scientific’s Sentinel cerebral embolic protection device may reduce the risk of disabling stroke, but it does not appear to reduce the overall risk of stroke.

Clinical Trials Cardiovascular Innovation

Latest From Research & Development

CDC Chooses Five Laboratories For Pathogen Genomics Network

The CDC’s $90m funding will be split among five laborites across the US over five years as a part of its pioneering Pathogen Genomics Centers of Excellence Network.

Policy Coronavirus COVID-19

Minute Insight: Smith + Nephew Expands VR-based Surgical Training

Smith + Nephew is expanding its suite of simulation technologies to train surgeons on new techniques before they enter the operating room.

Minute Insights Orthopedics

Fewer Than Half Of Children On Medicaid Receive Life-Saving Sickle-Cell Screenings, CDC Says

A CDC study found that fewer than half of children with sickle cell disease were getting screened for strokes, and fewer than 40% of children were taking recommended medications.  

Research & Development Consumer

TCT 2022: Edwards' Pascal Matches Abbott's MitraClip In CLASP IID

Results of the CLASP IID trial showed Edwards’ Pascal mitral valve repair system was non-inferior for safety and effectiveness compared to Abbott’s MitraClip device.

Clinical Trials Cardiology

Biden Issues Biotechnology Executive Order To Spur Research And Development

Summary: President Biden signed Executive Order 14081 to boost biotech R&D and provide regulatory clarity to industry.

Legislation Policy

BTIG Analyst Zooms Into Alcon’s Revamp Into ‘Building A Pharma Company Inside A Device Company’

In his recent report on Alcon, BTIG analyst Ryan Zimmerman estimated that its pharmaceutical portfolio could generate close to $900m in fiscal year 2022.

Ophthalmic Commercial Strategies
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