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With Just 7 Notified Bodies Expected By Mid-2021, How Can Companies Prepare For The IVDR?

The EU’s IVD Regulation is going to apply just a year later than the EU’s MDR. Where are the gaps and how can industry manage the IVD notified body shortage?

EU Europe Policy

One Edwards Lifesciences Site Chopped Its Open CAPAs By Half. Here’s How Your Firm Can Too

Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.

Quality Control Compliance Regulation

COVID-19: Newly Authorized Device From OraSure Subsidiary Allows At-Home Collection Of Saliva Samples

The device is the first that does not require a health care professional to supervise the saliva sample- collection process.

Coronavirus COVID-19 In Vitro Diagnostics Regulation

Edwards Returns To Growth In The Third Quarter

The company’s third-quarter sales were up 4% year-over-year as transcatheter aortic valve replacement procedure volumes returned to pre-pandemic levels.

Companies Clinical Trials Cardiovascular

Helius Seeks FDA De Novo For Portable Neuromodulation Stimulator For MS Patients

The FDA has asked the company for more information to support its PoNS therapy for multiple sclerosis patients with gait deficit, including an additional analysis of clinical data and labeling modifications.

Approvals Clinical Trials FDA

Execs On The Move: New CEO For Glycorex; Senior Execs For NuVasive And Itamar Medical

Biovica exec becomes Glycorex Transplantation CEO; Perimeter Medical Imaging AI CFO promoted to CEO; new blood at Aquarius Surgical Technologies, Itamar Medical and NuVasive; and more.

Commercial Appointments Medical Device

QUOTED. 22 October. Robert Ford.

Abbott reported third-quarter 2020 global sales of $8.9bn, driven by its strong position in COVID-19 tests. See what Abbott’s CEO Robert Ford said about it here.

Quoted Financing Diabetic Care

Infographic: Sleep Apnea Market To Reach Almost $10.3Bn By 2022

The market for devices to monitor and treat sleep apnea and its complications is set to grow by 7.3% annually ...

Device Week Podcast




Discussed in this episode:


FDA Proposes Negating Need For Biocompatibility Testing For Certain Materials

The agency says sponsors of some medical devices that touch skin may no longer need to provide biocompatibility testing data if the materials they’re ...

Regulation Approvals


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Policy & Regulation Explore this Topic

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GAO To Investigate Trump Admin Attacks On Scientific Integrity At FDA, CDC

The US watchdog agency accedes to three senators’ request to look into political pressures placed on the FDA and the CDC to alter the science behind their COVID-19 responses.

Policy Legislation Coronavirus COVID-19

Coverage Decisions For AlloMap Molecular Testing To Detect Cardiac Allograft Rejections Left Up To MACs

The US CMS has proposed that due to low Medicare use, it will not nationally cover AlloMap molecular tests to detect cardiac allograft rejections.

Policy Reimbursement Medicare

Latest From Policy & Regulation

UK MHRA Updates Northern Ireland And EU Device Regulation Guidance

The latest guidance from the UK devices regulator fills in some of the information gaps for companies addressing the Northern Ireland and EU27 markets after this year, seen through the lens of Brexit.

United Kingdom Regulation

FDA’s Biotin Interference Guidance Finalized

The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.

Guidance Documents FDA

CMS Proposes Coverage For Colorectal Cancer Blood-Based Tests – Except For Epigenomics’ Screen

The US Medicare agency coupled its proposed coverage memo on colorectal cancer screens based on blood-based biomarker tests with a note that the Epi proColon assay does not meet its criteria.

Policy Reimbursement

Warning Letter Roundup & Recap – 20 October 2020

No device-related warning letters were released by the US FDA the week of 20 October.

Device Warning Letters FDA

How To Register In Eudamed By The December Start Date: Commission Explains

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

Europe EU

Seating Of Barrett On Supreme Court Could Be Death Knell For ACA’s Chronic Illness Coverage

During her confirmation hearings, Judge Amy Coney Barrett denied it’s her goal to end all Affordable Care Act coverage, but some senators and legal experts disagree. And if the ACA is struck down, coverage for chronic disease treated with medical devices – including cancer, heart disease and diabetes – could fall by the wayside.

Policy Legal Issues

Quality Control & Compliance Explore this Topic

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How To Register In Eudamed By The December Start Date: Commission Explains

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

Europe EU

Permitting Initial Virtual Audits Under The MDR: Commission Decision Hangs In The Balance

The European Commission is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.

Compliance Enforcement

Priority Lane: Guidances On Risky Devices, 510(k) Reform Top FDA’s To-Do List

The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.

Guidance Documents Policy

Commercial Explore this Topic

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Neuromodulation Firm Lands €10.5M For Tinnitus Treatment

Funds will be used to expand European sales of the CE-marked Lenire device, scale-up manufacturing and progress US regulatory and reimbursement plans.

Companies Financing Ear

Latest From Commercial

Abbott’s 3Q $8.9Bn Sales Beat Wall Street Consensus, Medtech Sales Up 3.4%

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

Financing Diagnostics

HLTH 2020: Panel Finds Pandemic Accelerates Uses For Robots In Health Care, Even ‘Zumba’

The COVID-19 pandemic continues to drive innovation in robotics to provide care and comfort at a safe distance. 

Robotics Coronavirus COVID-19

APACMed: Johnson & Johnson On Using ‘Big’ For Good In The COVID-19 Challenge

Johnson & Johnson's Ashley McEvoy explains how the global medtech business should change, seen through the lens of the coronavirus pandemic.

Commercial Medical Device

Merit Medical To Pay $18M To Settle Kickback Case

The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.

Commercial Legal Issues

Medtronic, The Foundry Invest In New Transcatheter Mitral Repair Technology

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

Clinical Trials Deals

Philips Previews Five-Year Plan As Connected Care Returns Group To Growth In Q3

COVID-19 business volatility continues to impact the medtech industry, but Royal Philips is targeting modest comparable sales growth for 2020 after posting quarterly growth of 10%.

Commercial Medical Device

Clinical R&D Explore this Topic

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Long-Term Data Confirm Durability Of Medtronic’s DTM Back Pain Therapy

A randomized trial demonstrated the superiority of Medtronic’s DTM spinal cord stimulation waveform over conventional spinal cord stimulation for treating back pain.

Clinical Trials Innovation Research & Development

Latest From Research & Development

Abbott’s 3Q $8.9Bn Sales Beat Wall Street Consensus, Medtech Sales Up 3.4%

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

Financing Diagnostics

Two Studies Support Short Dual Antiplatelet Therapy With Abbott’s Xience DES

Results from two trials confirm patients at high risk of bleeding treated with Abbott’s Xience stent can be safely treated with short regimens of dual antiplatelet therapy.

Clinical Trials Research & Development

Boston Scientific's TAVR Pipeline Delayed; FDA Approval Of Acurate neo2 Set For 2024

The SCOPE II results could have helped support a PMA for Acurate neo2 in 2021, but the trial missed its primary endpoint, and the REPRISE IV trial of Boston Scientific's Lotus Edge TAVR system has been delayed by COVID-19.

Approvals Clinical Trials

Medtronic, The Foundry Invest In New Transcatheter Mitral Repair Technology

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

Clinical Trials Deals

Medtronic Announces Two New Trials To Expand TAVR Indications

The SMART trial will compare Medtronic’s Evolut TAVR systems to Edward’s Sapien 3 devices. Evolut EXPAND TAVR I will evaluate Evolut in patients with symptomatic moderate aortic stenosis or asymptomatic severe disease.

Clinical Trials Research & Development

Podcast: Impulse Dynamics CEO Says CMS Breakthrough Rule Could Boost R&D (And Is Good Use Of Tax Dollars)

Following the US Medicare agency’s recent proposed rule to give immediate national coverage for breakthrough devices, Simos Kedikoglou spoke with Medtech Insight about what it could mean for companies like his.

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