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Featured Stories



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

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 Cardiovascular

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

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

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

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 Artificial Intelligence

QUOTED. 21 October. Darla Hutton.

An expert panel at the virtual HLTH conference discussed the role of robotics in improving health and wellness in the health continuum. See what Darla Hutton, vice president of US marketing and customer hospital analytics at Intuitive Surgical, said about the future of robotics.

Artificial Intelligence Innovation Telehealth

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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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 Medicare

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 Regulation

Latest From Policy & Regulation

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

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

COVID-19 Antigen Tests Offer New Diagnostic Option In Germany

Germany’s COVID-19 testing strategy now permits the use and reimbursement of coronavirus antigen tests.

Germany Coronavirus COVID-19

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

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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Siemens Healthineers To Spend €160M Building R&D And Manufacturing Hub In India

The company is the second big medtech to announce a major investment in R&D in the country in 2020.

India Business Strategies Companies

Latest From Commercial

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

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.

Regulation Commercial

HLTH 2020: Amwell CEO Foresees Patient Demand Will Drive Telehealth’s Future

Amwell’s CEO Roy Schoenberg foresees a balance between in-patient and digital care, but risks in telemedicine and regulatory issues remain barriers.

Telehealth Digital Health

Clinical R&D Explore this Topic

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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 Research & Development

Latest From Research & Development

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.

Regulation Commercial

HLTH 2020: Amwell CEO Foresees Patient Demand Will Drive Telehealth’s Future

Amwell’s CEO Roy Schoenberg foresees a balance between in-patient and digital care, but risks in telemedicine and regulatory issues remain barriers.

Telehealth Digital Health

Medtronic Lays Out Plans To Achieve 5%+ Annual Growth

The medtech giant offered additional details on its ongoing restructuring plan intended to make the company more competitive.

Business Strategies Commercial

Breakthrough Pulmonary Hypertension Treatment To Enter Pivotal Trial Before Year End

IDE trial of SoniVie’s catheter device will be the first for a denervation treatment for PAH.

Clinical Trials Research & Development
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