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MDR Amending Regulation Officially Published And Already In Force

The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.

EU Europe Medical Device

Getting Personal With Brittany Barreto: From One-Time ‘Science Hater’ To Genetics Doctorate, DNA Dating App And Women’s Health Champion

Medtech Insight sat down with Brittany Barreto, CEO of FemHealth Insights, who participated in a panel discussion at SXSW 2023 on the $1t femtech industry, to talk about her journey to becoming a women’s health care champion.

Exec Chats Women's Health Artificial Intelligence

EU MDR Notified Bodies Reach 38 After Another Designation

Germany’s SZUTEST is the latest notified body to be designated under the EU Medical Device Regulation, bringing the total number to 38.

Europe EU Germany

Industry Supports Transparency On Proposed CMS Prior Authorization Rule

Industry trade groups applaud CMS’s proposal to increase transparency for prior authorization approvals but are asking for expedited timeframes to provide care.

Policy Reimbursement Medicare

Another Class I Recall For Datascope’s Aortic Balloon Pumps

Datascope/Getinge has initiated another recall of its Intra-Aortic Balloon Pumps, this time for a potentially faulty cable connection.

FDA Regulation Recalls

TEAM-NB Membership Increases By Over a Quarter Within Six Months

TEAM-NB was originally created to raise standards among notified bodies to an agreed harmonized level. Its latest expansion aims to continue that mission of spreading best conformity assessment practices.

Medical Device In Vitro Diagnostics EU

The EU NIS 2 Directive Is Here. What Does It Mean For Medtech?

The EU Network and Information Security (NIS) Directive 2 entered into force this year, replacing the original NIS Directive. Cybersecurity is at the heart of NIS 2, and some of the new provisions are particularly important for the medtech and health sector.

Europe EU Medical Device

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Policy & Regulation Explore this Topic

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News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More

News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.

FDA Policy Approvals

The EU NIS 2 Directive Is Here. What Does It Mean For Medtech?

The EU Network and Information Security (NIS) Directive 2 entered into force this year, replacing the original NIS Directive. Cybersecurity is at the heart of NIS 2, and some of the new provisions are particularly important for the medtech and health sector.

Europe EU Medical Device

Latest From Policy & Regulation

Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease

Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.

Europe United Kingdom

How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance

UTIs are one of the most common reasons for antibiotics to be prescribed, but accurate and timely diagnostic tools are lacking. England’s NICE has identified four innovative IVDs that could be rolled out for NHS patients, but said more research is needed on these products first.

Europe EU

Switzerland: US FDA’s Medtech Can Bridge Innovation Gap Left By MDR

Setting the patient safety bar too high will likely have the opposite effect in the case of the EU MDR. So believes the medtech industry in Switzerland, where work has begun at government level to pave the way for Swiss patients to have access to US FDA-approved medtech.

Switzerland Regulation

DOJ Files Preliminary Injunction Against Neoprene Manufacturer

The US Department of Justice filed an injunction to limit chloroprene emissions from Denka Performance Elastomer, a facility that makes device components as well as other neoprene products.

Legal Issues Regulation

COVID-19 EUAs To Stay Active After Public Health Emergency Ends

Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.

Coronavirus COVID-19 Policy

EU IVD Regulation Delaying Clinical Trials Using Diagnostics

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

Clinical Trials Regulation

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

DOJ Files Preliminary Injunction Against Neoprene Manufacturer

The US Department of Justice filed an injunction to limit chloroprene emissions from Denka Performance Elastomer, a facility that makes device components as well as other neoprene products.

Legal Issues Regulation

EU IVD Regulation Delaying Clinical Trials Using Diagnostics

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

Clinical Trials Regulation

Time For Talking: MedTech Europe Wants Clarity And Transparency Over MDR Amendment

The MDR amending regulation is on the cusp of being enforced. Most feel it is long overdue to prevent further medtech regulatory chaos in the EU. But the new text raises many questions itself. Medtech Insight spoke to MedTech Europe’s Petra Zoellner to understand what is needed next.

EU Europe

Commercial Explore this Topic

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News We’re Watching – FDA Nixes Neuralink Trials, Layoffs at J&J, Novel Knee Implants

This week, we learned that the US FDA thinks Elon Musk’s Neuralink brain interface device isn’t ready for human trials.  Additionally, J&J cut about 300 medtech jobs, Stryker launched a knee implant, and Active Implants’ meniscus replacement device made it to the FDA’s advisory panel calendar. 

Regulation Commercial FDA

Latest From Commercial

Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease

Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.

Europe United Kingdom

Cordio Medical Is Using Patients’ Voices To Spot Heart Failure

As fluid builds up in the lungs, the “engine” of a patient’s voice is smothered. Medtech Insight spoke to Cordio Medical’s CEO about how the company’s smartphone-based software could warn clinicians almost three weeks in advance of decompensation.

Innovation Cardiology

Could A Robot Be Used To Grow New Human Cells? The UK Regulator Thinks So

Stem cell therapies have the potential to treat a vast range of conditions, from forms of blindness to Parkinson’s disease, but manufacturing these products is difficult. The UK medtech regulator is exploring whether a robot could solve this problem.

Europe EU

Becton Dickinson Receives FDA Clearance For Vaginal Panel To Detect Vaginitis

BD said its newly FDA-cleared Vaginal Panel can detect three most common infectious causes of vaginitis with a single swab, reducing the need for repeat testing.

Approvals FDA

Harbinger Health CEO Stephen Hahn On Early Cancer Detection To ‘Move The Needle’ On Survival

Medtech Insight spoke with Stephen Hahn, ex-FDA commissioner and CEO of Harbinger Health, who attended SXSW, about the firm’s blood-based cancer test in development.

Exec Chats Cancer

Speaking To AstraZeneca And Huma About Digital’s Value For Pharma

AstraZeneca has been working with Huma to develop a series of software-based tools for monitoring patients. Medtech Insight spoke to both companies about the value of these partnerships and the potential challenges.

Digital Health Platform Technologies

Clinical R&D Explore this Topic

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Digital Health Roundup: Omar Ishrak’s SPAC; AI In Dermatology, IVF, Imaging; Wellness Apps And Trust

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights how Alife Health is using its AI-based platform for IVF to increase chances for successful pregnancies while Barnaby Pickering discusses how AI Medical Technology is using AI to detect melanoma. Reed Miller talks about weight-loss device maker Allurion Technologies’ signed SPAC deal.

Digital Health Artificial Intelligence Approvals

Latest From Research & Development

Medtronic Earns CE Mark For Affera Ablation System, Touts New PFA Results

Results of the PULSED AF trial confirm that Medtronic’s PulseSelect pulsed field ablation is safe and effective for atrial fibrillation ablation. The company will likely incorporate PulseSelect into its Affera cardiac mapping and ablation system, which will soon be available in Europe.

Approvals Clinical Trials

Harbinger Health CEO Stephen Hahn On Early Cancer Detection To ‘Move The Needle’ On Survival

Medtech Insight spoke with Stephen Hahn, ex-FDA commissioner and CEO of Harbinger Health, who attended SXSW, about the firm’s blood-based cancer test in development.

Exec Chats Cancer

Increase Access To MedTech: AdvaMed’s Priorities For The 118th Congress

AdvaMed’s Medical Innovation Agenda for the 118th Congress emphasizes increased access to medical devices, from reimbursement for breakthrough devices to boosting America’s start-ups to closing the care disparities for underserved communities.

Policy Reimbursement

FDA Clears Abbott’s Modified CGM For Automated Insulin Delivery Integration, Label Expansion

Abbott announced today it plans to integrate its FDA-cleared modified CGMs with insulin pump makers, including Tandem and Insulet, likely later this year.

FDA Approvals

Genomics England Taps Medical Imaging Firm Sectra To Bolster Cancer Research

Genomics England, a UK government-owned genomic sequencing company, has joined forces with Swedish medical imaging and cybersecurity firm Sectra to “push the boundaries” of cancer research by linking up cancer images from NHS trusts data with genomics data and AI.

Europe EU

Cardio Conversations: Abbott's Electrophysiology CMO Christopher Piorkowski On Cardiac Mapping, PFA, VT And More

In this episode of Medtech Insight’s new podcast series focused on cardiovascular technology, editor Reed Miller talked to Christopher Piorkowski, Abbott's chief medical officer for electrophysiology.

Interviews Cardio Conversations
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