New to Medtech Insight?
Start a free trial today!
Register for our free email digests:
Register for our free email digests:
Jump To Section
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.
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.
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.
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.
Spotlight On Europe
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.
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.
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.
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.
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 ...
Latest News
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 ...
Data Trackers
Recent Tweets from Medtech InsightPolicy & Regulation Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
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.
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.
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.
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.
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.
Quality Control & Compliance Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
Commercial Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
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.
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%.
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.
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.
Clinical R&D Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
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.
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.
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.
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.
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.
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.