Commercial
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Companies
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Global Regulators Home In On Regulatory Reliance, Propose Universal Framework
Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.
News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More
Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.
Medtech’s Leading Revenue Earners In 2023: Johnson & Johnson Tops $30bn
Abbott’s weaker rapid diagnostic sales see the erstwhile industry leader slip down the global 2023 medtech rankings, while Johnson & Johnson passes it on the way up on the back of strong external and internal growth.
'There Is Work To Do:' Sean Salmon Discusses Medtronic's Recent Hard-Won Cardio Breakthroughs
Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval of the Symplicity Spyral renal denervation system, recent approvals of the PulseSelect pulsed field ablation system and extravascular ICD, and the company's plans for transcatheter aortic valve replacement.
Deals and Financings
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News We're Watching: Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.
SVB’s Milo Bissin Predicts ‘Reckoning In 2024’ For Health Care Companies With Sky-High Valuations
VC funding will remain challenging for many in the health care industry, Silicon Valley Bank’s market manager Milo Bissin told attendees at the recent DHIS West conference. Companies focusing on promising areas such as AI-powered technologies, women’s health and value-based care likely have the best chances to draw investors’ attention.
Change Of Plan: Medtronic Drops Ventilators, Keeps Monitoring, Forms New Unit
Medtronic will stop producing ventilators and combine the rest of its patient monitoring and respiratory interventions business into a new business called acute care and monitoring. The company had previously announced plans to divest all of the patient monitoring and respiratory intervention business.
UK Offers £10M Funding To Eight Medtech Innovators
The Innovative Device Access Pathway pilot has launched in the UK with eight new promising medical technologies. The cohort is overwhelmingly diagnostic-focused, with innovative testing for Alzheimer’s, stroke, and liver cancer, amongst others.
Market Access
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UK Offers £10M Funding To Eight Medtech Innovators
The Innovative Device Access Pathway pilot has launched in the UK with eight new promising medical technologies. The cohort is overwhelmingly diagnostic-focused, with innovative testing for Alzheimer’s, stroke, and liver cancer, amongst others.
2024 Radar: UK Medtechs Up The Pace On Sustainability And Assess AI Potential
Three UK medtech companies’ views on how their businesses will be influenced by external factors in the coming year.
NICE Launches ‘Concierge System’ To Guide Companies Through HTA Process
The health technology assessment body for England and Wales has launched an integrated, flexible advice portal to help guide companies through its potentially “bewildering” health system.
Innovation Adoption: ‘Medtech’s Ongoing Challenge Of The Day’
UK ministers are increasingly focusing on the need to improve uptake of new technologies in the National Health Service. Ambitious programs have been launched but implementing them effectively for lasting change in a delivery system under acute stress is a challenge of a different order.
Market Intelligence
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'Blah-Blah' May Subside, But Harnessing AI Ethically, Impactfully Is Key For Medtech In 2024
Views from medtech industry leaders and investors on the most significant uncertainties and opportunities facing the sector in 2024.
Time Running Out To Comply With New EU Sustainability Legislation
At a webinar organized by the Association of the European Self-Care Industry, sustainability expert Onur Durmus, partner at ERM, gave an overview of the Corporate Sustainability Reporting Directive and what consumer health companies must do to ensure compliance.
‘Faster, Better, More Efficient’ – Why Bayer Is Investing In ‘Precision Health’
Bayer's head of R&D and chief scientific officer David Evendon-Challis talked to Medtech Insight about the company's prescision health business, including a holistic and personalized approach to digital self-care.
Pear Bankruptcy Filing Highlights Difficult Challenges Facing Digital Therapeutics
Pear Therapeutics filed for Chapter 11 bankruptcy in April and sold its remaining assets in an auction for about $6m. The demise of one the pioneers in the prescription digital therapeutics industry highlights the challenges PDT developers face getting their products reimbursed.
Appointments
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Execs On The Move: February 2023
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Execs On The Move: January 2024
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
News We’re Watching: LivaNova Names CEO; Surgical Robot Goes To Space, And More
Medtech Insight's News We're Watching highlights medtech industry developments we are following: LivaNova named a new CEO, Roche confirmed plans to launch a continuous glucose monitor, Virtual Incision sent its surgical robot into orbit, and Synchron announced a deal with Acquandas to advance its brain interface technology.
Breaking: Diagnostics Head Stenzel Leaves FDA
Timothy Stenzel, who directed the Office of In Vitro Devices since 2018, reportedly retired at the end of 2023.
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