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EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”

A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far with its proposals?

Europe EU Medical Device

Dexcom’s G7 Expands Globally After A Long Wait

Dexcom has expanded the availability of its G7 sensor to five new markets, including the UK and Germany. FDA approval in the US has been delayed by software changes.

Diabetic Care Business Strategies Approvals

Second MDR Polish Notified Body Designation Means EU Total Reaches 33

New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.

EU Poland Europe

Minute Insight: Viagra May Face Stiff US Competition From Futura’s Gel-Based Device

MED3000 works in 10 minutes and will be available over the counter, if approved.

Drug Delivery Technology Commercial Retail

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

Cardio Catch-Up: Medtronic, Recor, Pulnovo Report Progress On Denervation To Treat Hypertension

The late-breaking clinical trial presentations at this year’s Transcatheter Cardiovascular Therapeutics conference in Boston included new results from trials of three different minimally invasive approaches to treat uncontrolled hypertension.

Cardiology Approvals Clinical Trials

FDA Publishes Guidance On Radiology Images And Device Data For Submitting 510(k)s

The US FDA has updated guidance on computer-assisted detection devices that was first released in 2012. The document, which is intended to help developers win FDA approval of their products, was last updated in 2020.

FDA Policy Diagnostic Imaging

China Market Growth Spurs Siemens Healthineers To Restructure Asia Ops

Germany-headquartered Siemens Healthineers has uncoupled China from the rest of its Asia business to maximize opportunities in the world’s largest medtech market-in-waiting.

Asia Pacific Business Strategies China

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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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European Regulatory Roundup, September 2022: Stakeholders Start Taking Radical Decisions

The regulation of clinical evidence and cybersecurity as well as lack of auditor availability were among the topics causing most concern to the medtech industry in September. But obstacles to the smooth implementation of the Medical Device and IVD Regulations persist and some actors are taking matters into their own hands.

Europe EU Italy

Potential Pump Malfunction Results In Class I Recall For LifeSPARC Circulatory System

The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.

FDA Recalls Regulation

Latest From Policy & Regulation

Warning Letter Close-Outs – September 2022

The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.

Warning Letters Regulation

Warning Letter Roundup & Recap – September 2022

Med Pen Concepts LLC was the only recipient of a device-related warning letter from the US Food and Drug Administration last month.

Regulation FDA

Global Medtech Guidance Tracker: September 2022

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

Guidance Documents Regulation

European Commission Reshuffle Sees New Innovation Focus For Devices

Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.

EU Europe

Small Business Research Grants Reauthorized Under The Wire

Congress extended the Small Business Innovation Research and Small Business Technology Transfer programs, right before they were set to expire on 30 September.

Policy StartUps and SMEs

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

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Warning Letter Close-Outs – September 2022

The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.

Warning Letters Regulation

Warning Letter Roundup & Recap – September 2022

Med Pen Concepts LLC was the only recipient of a device-related warning letter from the US Food and Drug Administration last month.

Regulation FDA

European Commission Reshuffle Sees New Innovation Focus For Devices

Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.

EU Europe

Commercial Explore this Topic

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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

Latest From Commercial

Novartis Heart Health Catalyst Announces Dual Winners

PocDoc and Lifelight have won the Novartis’ Heart Health Catalyst program and will work on smartphone-based lipid-measuring and clinical vital signs tools for evaluating cardiac health on a population level.

Platform Technologies Financing

Cardio Catch-Up: Medtech Innovation Takes Center Stage At TCT 2022

This edition of Medtech Insight’s regular round-up of heart-tech news covers some highlights of this years’ Transcatheter Cardiovascular Therapeutics (TCT) meeting in September, including the latest trials of Abbott's Amulet left-atrial appendage closure device and Medtronic's Intrepid transcatheter mitral valve replacement.

Cardiovascular Innovation

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

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

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

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

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

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

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

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

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
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