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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%.
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.
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.
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.
Spotlight On Europe
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.
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.
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.
QUOTED. 19 October. Roy Schoenberg.
Amwell’s CEO Roy Schoenberg said during the HLTH virtual conference he foresees a balance between in-patient and digital care with new technologies opening up a “new narrative” to reimagine health care. See what the telehealth company leader said about it here.
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:
Citing Shortages Tied To COVID-19, FDA Allows Some Alternative Flu Test Materials
The agency won’t require a 510(k) if manufacturers make some substitutions for materials now in high demand for COVID-19 tests.
Data Trackers
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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.
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.
Latest From Policy & 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.
US Election 2020: Here’s Who Industry’s Donating To
US senatorial friends of the device industry running competitive races in 2020 are being aided by medtech PAC dollars this fall.
Interview: Diagnostics' Vital Role Is Something to Shout About, Says UK's BIVDA
Diagnosing and mapping COVID-19 are the keys to controlling the pandemic, and the IVDs industry is crucial to their success. But unclear messaging from the center is not helping, says incoming BIVDA chief operating officer Helen Dent.
England’s HTA Body To Overhaul Product Selection Process
Proposals from NICE that are out for consultation are intended to boost the HTA body’s efficiency, improve transparency and governance, and raise the quality of its guidance.
What You Need to Know About Clinical Evidence For The EU IVDR
With growing urgency for the IVD industry to start compliance with the IVD Regulation, NSF’s Robyn Meurant explains the importance of getting clinical evidence right first time
11 New Telehealth Services Will Be Payable By CMS During Pandemic, Agency Says
The US Medicare agency will allow reimbursements for a bevy of new telemedicine services during the COVID-19 public health emergency, it announced on 14 October.
Quality Control & Compliance Explore this Topic
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Warning Letter Roundup & Recap – 13 October 2020
Battelle Memorial Institute, which makes its Critical Care Decontamination System under emergency use authorization from the US FDA, was dinged by the agency for Medical Device Reporting violations. It’s the only device-related warning letter released by the FDA over the past week.
US FDA Recognizes Case For Quality Collaborative Community
The Case for Quality Collaborative Community – or CfQcc – affords stakeholders across industry a safe space where they can rally around an array of topics to advance medical device quality and safety.
Icy HHS/FDA Relations Could Complicate An Already Drawn-Out Quality System Reg Rewrite
A roundup of last month’s top US policy and regulation stories from Medtech Insight: the latest on the US FDA’s Quality System Regulation harmonization efforts; the FDA’s Bakul Patel talks the inevitable future of digital health; a Sanofi usability expert gives a peek at how the company’s conducting human factors studies in the age of COVID-19; and more.
Commercial Explore this Topic
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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.
Latest From Commercial
Execs On The Move: Spectrawave Welcomes New CEO; e-Therapeutics Promotes Exec To CEO
Former NinePoint Medical CEO takes the helm at Spectrawave; Vigene Biosciences COO heads over from NATRIX Separations; e-Therapeutics executive chairman also takes reigns as CEO; and more.
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.
Teladoc Sues Amwell Over Alleged Patent Violations Related To Telemedicine Technologies
The legal battle between Teladoc and Amwell heats up as the post-pandemic future of telehealth remains in question.
US Government Awards $481M To Help Cue Health Expand COVID-19 Test Production
Cue’s point-of-care molecular test earned an FDA emergency use authorization in June.
J&J Bounces Back In Q3, Led By Interventional Devices
Johnson & Johnson’s worldwide medical device revenues grew about 50% sequentially in the third quarter to $6.2bn.
HLTH 2020: Teladoc And Livongo Say Clients, Doctors Excited About Merger, Cross-Selling Deal With Florida Blue
The CEOs of Teladoc and Livongo said the merged digital health giant will create one-stop shopping for health care.
Clinical R&D Explore this Topic
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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.
Latest From Research & Development
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.
Teladoc Sues Amwell Over Alleged Patent Violations Related To Telemedicine Technologies
The legal battle between Teladoc and Amwell heats up as the post-pandemic future of telehealth remains in question.
US Government Awards $481M To Help Cue Health Expand COVID-19 Test Production
Cue’s point-of-care molecular test earned an FDA emergency use authorization in June.
J&J Bounces Back In Q3, Led By Interventional Devices
Johnson & Johnson’s worldwide medical device revenues grew about 50% sequentially in the third quarter to $6.2bn.
HLTH 2020: Teladoc And Livongo Say Clients, Doctors Excited About Merger, Cross-Selling Deal With Florida Blue
The CEOs of Teladoc and Livongo said the merged digital health giant will create one-stop shopping for health care.
FDA Grants EUA For Access Bio’s Lateral Flow COVID-19 Antigen Test
Access Bio joins Abbott as the second company with FDA authorization to distribute PCR, antigen and antibody tests for COVID-19.
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