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MTI 100 2022: Big Cardio Medtechs Are Moving ESG Agenda To Center Stage
Medtech Insight outlines major trends shaping the top 15 cardiovascular device companies included in the latest Medtech 100 rankings. They include a growing need to reach underserved patient populations, ongoing staffing and other challenges created by the COVID-19 pandemic, and reimbursement obstacles.
Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.
Exec Chat: Cognetivity’s Simple Brain Test Could Unlock Trillions In Health Care Savings
Cognetivity Neuroscience’s CognICA tool uses a language and education-independent approach to assess whether a patient is exhibiting cognitive decline, so it could also aid drug discovery.
Stryker Fails To Convince FDA To Exempt Patient-Transport Devices
The US agency didn’t buy Stryker’s argument in its April petition that there is no data suggesting patient-transport devices have a history of false and misleading claims.
Spotlight On Digital Health
Digital Health Technologies: Where The Shift Is Needed In The EU To Increase Uptake
The market for the reimbursement of digital health technologies is being held back because of the current fragmentation in reimbursement and funding. MedTech Europe is calling for change.
Speaking Of Medtech, Ep. 4: FDA’s Regulation Of Digital Devices
Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation
Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases
Digital Health Roundup: Digital Therapeutics Push Ahead On Standards, Coverage; FDA’s Software Guidance
MTI 100 Review: Medtechs Drive To Keep The Status Quo In A Year Like No Other
The performances of the leading medtechs in the first year of the COVID pandemic were impossible to compare and certainly unrepresentative of normal business cycles and competitive activity. Elective care was largely put on hold and emergency needs boosted exceptional demand for certain product types. More than anything else, 2020 tested management's planning skills.
Boston Scientific Advances First ‘Modular’ Cardiac Rhythm Management System
The MODULAR ATP clinical trial has begun to enroll patients to evaluate the safety, performance and effectiveness of Boston Scientific’s mCRM modular therapy system, which includes the Emblem MRI S-ICD and the Empower MPS leadless pacemaker.
MTI 100 2022: Big Cardio Medtechs Are Moving ESG Agenda To Center Stage
Medtech Insight outlines major trends shaping the top 15 cardiovascular device companies included in the latest Medtech 100 rankings. They include a growing need to reach underserved patient populations, ongoing staffing and other challenges created by the COVID-19 pandemic, and reimbursement obstacles.
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Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases
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‘A Very Broad Search’: Philips Pushes Back On FDA Claim Of 222,000 Uninvestigated Complaints
Royal Philips says a US FDA investigator wildly overcounted the number of complaints related to recalled breathing machines, disputing an inspection report that says the company failed to investigate hundreds of thousands of complaints. News of the agency’s inspection of a Philips facility – and what might come next for the firm – topped our list of most-read articles in November.
IVD Regulation Amendment: It’s Now All Down To The European Parliament
The European Council has paved the way for swift adoption of the proposal to amend the IVD Regulation, given the pressures the IVD sector is under. All eyes are now on the European Parliament.
Latest From Policy & Regulation
Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.
US FDA Proposes Independent Contractor To Track User Fee Dollars Used To Pay FTEs
The agency published minutes from three MDUFA V user fee meetings with medtech industry. The talks include conversations about carryover funds and filling FTEs from past user fee deals.
Digital Health Roundup: A Season For Interviews, New Frontiers, AI, Cybersecurity
In this roundup feature focusing on developments in digital health, Medtech Insight highlights interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements from November.
Rob Ten Hoedt Reelected Chairman Of MedTech Europe Board
Seven changes have been made to the MedTech Europe board while the tenure of the current chair, a familiar face and well experienced in the role, has been extended for two years.
Biden Announces Insurance Coverage For OTC COVID-19 Tests
The White House also announced it would double commitment it made in September for number of OTC test kits to be distributed free by community groups from 25m kits to 50m and would add rural clinics to the program.
Device Week, 3 December 2021 – What Do The New Eudamed Modules Mean For Medtech?
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.
Quality Control & Compliance Explore this Topic
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Latest From Quality Control
Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.
Device Week, 3 December 2021 – What Do The New Eudamed Modules Mean For Medtech?
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.
NuVasive Selling Titanium-Based Precice Orthopedic Devices Again, Launches Recall To Update IFU
NuVasive Inc. is marketing its Precice specialized orthopedic devices made of titanium once again after voluntarily pulling them from the market in April over concerns about the safety of the steel-based version of the product. The firm also initiated a recall to address changes in the instructions for use for titanium Precice.
OUTLOOK 2021
Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings
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Execs On The Move: Thanksgiving Roundup – Appointments Abound
BD, Baxter, Omron, and Zimmer Biomet are all big names that have appointed new executives in the past two weeks.
Latest From Commercial
Digital Health Roundup: A Season For Interviews, New Frontiers, AI, Cybersecurity
In this roundup feature focusing on developments in digital health, Medtech Insight highlights interviews with Medtronic, Abbott and Congenica, partnerships and launches, and AI and cybersecurity announcements from November.
Abbott Claims DexCom CGM Suits Renege On Tech-Sharing Agreement
Abbott says DexCom’s patent suits involve technology that was already the subject of a settlement, and raise venue questions.
Bipartisan Bill Seeks To Address US Supply Chain Issues, Prevent Further Crises
Lawmakers have introduced legislation that would establish a national database to help manufacturers expedite the supply chain and avoid further disruptions.
NuVasive Selling Titanium-Based Precice Orthopedic Devices Again, Launches Recall To Update IFU
NuVasive Inc. is marketing its Precice specialized orthopedic devices made of titanium once again after voluntarily pulling them from the market in April over concerns about the safety of the steel-based version of the product. The firm also initiated a recall to address changes in the instructions for use for titanium Precice.
Minute Insight: MeMed Announces Viral/Bacterial Infection Differentiation Results, Commercial Partnership
DiaSorin will distribute MeMed BV, a rapid point-of-care test that can differentiate bacterial and viral infections, under a new commercial agreement.
I Think, Therefore I Write: Breakthrough Device Turns Thoughts Into Words
Blackrock Neurotech’s MoveAgain technology platform allows patients who have been silenced by ALS, paralysis and other spinal cord injuries the ability to better communicate via text. The device has been granted breakthrough status by the US FDA.
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Abbott Focuses On Improving Early Diagnosis Of Vascular Disease To Improve Outcomes
Nick West, chief medical officer for Abbott’s vascular business talked to Medtech Insight about Abbott’s efforts to improve the assessment and treatment of vascular disease long before patients need an intervention.
Latest From Research & Development
Minute Insight: Pulsed AF Trial Of Medtronic’s PulseSelect PFA System Completes Enrollment
PULSED AF is a 500-patient pivotal trial of Medtronic’s PulseSelect PFA system for treating both paroxysmal and persistent atrial fibrillation in patients who have not responded to drugs.
US FDA-Sponsored Cybersecurity Threat Modeling Playbook Tries To Make It Simple
The MITRE corporation and MDIC have produced a manual on how to use cybersecurity threat modeling to make safer medical devices. The document asks four basic questions and provides helpful examples.
Minute Insight: FDA Approves First Fluorescent Imaging Agent For Ovarian Cancer
On Target Laboratories’ Cytalux (pafolacianine) is now approved for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
Exec Chat: Medtronic’s Linnea Burman Targets 'Consensus-Driven Care' Using AI, Robotics In Spine Care
Linnea Burman, the general manager of enabling technologies for cranial and spinal technologies at Medtronic, talked to Medtech Insight about plans for the Mazor spinal robotic system, the incoming new president of the division, and other new developments.
AI Expert: Awareness Is Key To Managing Biases
A Walden University professor discussed various types of biases AI/ML developers need to take into consideration during the recent Xavier Health AI Summit. She noted a working group will produce a white paper laying out different types of biases to raise awareness.
Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation
Cala Health’s FDA-cleared Cala Trio wearable for treating essential tremor is currently being tested in Parkinson’s disease patients and is targeting a $20bn global market opportunity.
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