Cristiano Antonino is a photographer and professional drone pilot based in Parma, Italy.

Circulatory assistance: the intra

31 Jul 2023  |  Emergency Live  |  English  |  Medical Devices

The intra-aortic counterpulsation is a cardiology device providing temporary circulatory assistance by supporting the left ventricle of the heart. Developed in the 1960s by Dr. Kantrowitz and his team at Grace Sinai Hospital, it was first clinically implanted in 1967 at Maimonides Medical Center. The device, further developed for cardiac surgery by Dr. David Bregman in 1976, and later refined by Dr. Subramanian in 1978, works by decreasing myocardial oxygen demand and increasing cardiac output. It consists of a mechanical part and a catheter with a balloon, which is introduced into the thoracic aorta via the femoral artery. The device's operation is synchronized with the cardiac cycle, reducing the workload on the heart and increasing blood flow. Potential complications include tissue ischemia, renal failure, and cerebral embolism. Proper management and routine maintenance by healthcare professionals are crucial to avoid life-threatening complications.

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Medical Devices Cardiology Health

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I'm a freelance journalist from Australia but based in Hanoi, Vietnam. I have a degree in journalism from RMIT and a Masters in International Relations from the University of Melbourne. I've been in Hanoi for over a year and have developed extensive networks and contacts.

Life Sciences Quarterly (Q4 2019): 2019 Roundup on Life Sciences Hot Topics

31 Dec 2019  |  www.lexology.com  |  English  |  Medical Devices

The Life Sciences Quarterly report for Q4 2019 covers significant developments, trends, and hot topics in the pharmaceutical, biotechnology, and medical devices industries. The report includes discussions on governance, licensing, intellectual property, FDA regulatory and clinical research, with a focus on the impact of real-world evidence, China's influence in U.S. research, and patent law trends. Notable topics include the Clovis decision's effect on board oversight, profit splits in collaborations, and legal and regulatory landscapes related to real-world evidence. The report also addresses concerns about foreign influence in U.S. research, particularly from China, and the implications for intellectual property and knowledge transfer. The FDA's approach to real-world evidence and its potential use in regulatory submissions is examined, highlighting the agency's current skepticism and the likelihood that real-world evidence will complement rather than replace traditional clinical trials. The report also touches on the implications for industry, including the need for compliance with export controls and the potential for government scrutiny of industry scientists.

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Medical Devices Life Sciences Pharmaceuticals Biotechnology FDA Regulatory Clinical Research Intellectual Property Corporate Governance Real-World Evidence Foreign Influence in U.S. Research Patent Law Trends

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Daniel Brown is a experienced journalist based in Paris, France. For the last 30 years he has traveled the world reporting in cultural, political and sporting fields, essentially in English and French. His features and reports regularly feature in publications in England and the US, and he has been ...

Harnessing the Clinical and Economic Power of Pushable Coils - Endovascular Today

17 Mar 2024  |  Endovascular Today  |  English  |  Medical Devices

The article is a discussion among a panel of experts in the field of interventional radiology, focusing on the use of pushable versus detachable coils in medical procedures. The panelists, who are affiliated with various medical institutions and have disclosed their ties to medical device companies, share their preferences and experiences with different types of coils, considering factors such as cost, ease of use, and clinical situations. They also discuss the importance of fiber in coils and the pressures they face to reduce costs due to supply chain demands and the alignment with value-based care. The article concludes with a mention of Cook Medical's pushable coils and an invitation to learn more about their products.

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Medical Devices Interventional Radiology Healthcare Economics

Annie Burns-Pieper is an award-winning Canadian journalist based in Montreal, Quebec who has worked with Al Jazeera, BBC, The Globe and Mail, CBC, The Toronto Star, The Thomson Reuters Foundation,  CTV and Global News.

She specializes in investigative journalism.


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Health Canada rarely tracks sex of patients in adverse medical device incidents, data show

01 Oct 2023  |  The Globe and Mail  |  English  |  Medical Devices

Health Canada has not consistently tracked the sex of patients in adverse medical device incidents despite a commitment to do so, with sex data missing in 95% of cases between February 2020 and July 2021. Experts argue that tracking sex is crucial for understanding device failures and their impact on different groups. The Scientific Advisory Committee on Health Products for Women is urging Health Canada to make sex data collection mandatory. The article highlights the broader issue of gender bias in medical research and device approval processes.

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Medical Devices Health Gender Issues

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I am a multilingual reporter currently on leave of absence from Dow Jones Newswires and The Wall Street Journal, where I covered the European pharmaceutical industry, healthcare and various business topics for the past three and a half years.
 
At the moment I am pursuing freelance writing and ...

Ypsomed to Supply Novo Nordisk With Autoinjectors

20 Sept 2023  |  ADVFN  |  English  |  Medical Devices

Swiss medical-devices manufacturer Ypsomed will supply Novo Nordisk with 1 million autoinjectors under a long-term agreement, expanding its manufacturing capacities. Third-party manufacturers will also participate under a royalty scheme. The agreement will not impact Ypsomed's financial outlook for the current year.

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Medical Devices Pharmaceuticals Business Agreements

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Ruth Doris is a journalist based in Dublin, Ireland.

Firm wears heart on its sleeve

01 Oct 2023  |  Irish Examiner  |  English  |  Medical Devices

Oisín McGrath's Galenband, a wristband designed to monitor heart activity for up to 90 days, originated from his personal experience with heart rhythm abnormalities and a master's thesis at NUI Galway. The device aims to provide a more reliable method for detecting intermittent symptoms compared to traditional short-term monitors. The project has received significant recognition and funding, including a €500,000 grant from Enterprise Ireland, and has been acknowledged by institutions like MIT and the National Disability Authority. Clinical studies for the Galenband are expected to begin in about 18 months.

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Medical Devices Heart Health Innovation

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Debra Krol is a Native American journalist based in Phoenix, United States of America.

Specialties: Native American issues, including science and environmental issues, economic development, business, Native American art; travel/tourism [both Native and mainstream]; and photojournalism.

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Abhinandan Mishra is a print journalist based in Delhi, India who has an experience of more than 12 years. He specialises in investigative issues, matter relating to terrorism, intelligence. He has covered three general elections and multiple assembly elections across the country. He is also a ...

Fine for outsourcing cardiac tests to India

01 Oct 2023  |  sundayguardianlive.com  |  English  |  Medical Devices

Two US-based medical device companies, BioTelemetry, Inc and CardioNet, LLC, will pay $44.8 million to settle allegations of outsourcing cardiac test analysis to non-qualified technicians in India. The Department of Justice revealed that a significant portion of ECG data for federal healthcare programs was reviewed by underqualified offshore technicians. The issue was brought to light by whistleblowers, who received $8.3 million. Philips, which acquired the companies in 2020, did not respond to inquiries about the impact on Indian patients.

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Medical Devices Outsourcing Legal Issues

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Luís Silva is a photographer/jornalist based in Faro, Portugal.

Economic evaluations of medical devices in paediatrics: a systematic review and a quality appraisal of the literature

31 Mar 2024  |  BioMed Central  |  English  |  Pediatric Medical Devices

This systematic review and quality appraisal study focuses on the economic evaluations (EEs) of medical devices used in pediatrics. It identifies a gap in the development of pediatric-specific devices, with most approved devices being designed for adults. The study highlights the challenges in designing and approving pediatric devices due to stringent safety and ethical requirements, small market size, and the prevalence of 'off-label' use of adult devices in children. It emphasizes the need for robust EEs to inform Health Technology Assessment (HTA) decisions and discusses methodological gaps and recommendations for future research. The study also assesses the quality of reporting in existing literature using the CHEERS 2022 checklist and identifies a lack of reporting on conflicts of interest and funding sources. The review concludes that there is a need for more informed HTA decisions that consider the unique needs of child health and calls for methodological advancements in EEs for pediatric devices.

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Pediatric Medical Devices Health Technology Assessment Economic Evaluation

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Victoria Smith is a broadcast journalist, reporter, presenter, VJ and editor based in London, United Kingdom.
She has over 25 years experience in TV, radio, digital and print and is also a media trainer.
Victoria works as a UK correspondent for Euronews and a reporter/producer for Good Morning ...

Interview with the CEO of MARACA International

15 Jun 2020  |  www.medicaldevice-network.com  |  English  |  Medical Devices

MARACA International, a Belgium-based consulting company, specializes in regulatory, quality, and clinical services for medical device and in-vitro diagnostic device companies. Founded by Dr. Luc Van Hove, the company aims to support the introduction of nanotechnology-based devices to European and American markets. MARACA has been recognized for its high-quality services and has adapted to the COVID-19 pandemic by participating in efforts to bring compliant medical devices and tests to market quickly. The company is also involved in regulatory discussions and scientific sessions to address challenges in the medical device industry.

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Medical Devices Regulatory Affairs Clinical Services

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Candice Tang is a multi-media journalist based in Hong Kong.

Watch these five Xtalks webinars to learn all about the new EU Medical Device Regulation (MDR)

01 Nov 2019  |  Xtalks  |  English  |  EU Medical Device Regulation

The article discusses the upcoming EU Medical Device Regulation (MDR), which will take effect in May 2020, replacing the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The MDR aims to enhance product quality and safety by emphasizing clinical evaluations and data. Manufacturers face the challenge of assessing their product portfolios for compliance, which is a costly and time-consuming process. The article promotes five Xtalks webinars that provide insights into achieving compliance with the new regulations. These webinars feature experts from various organizations, including Kalypso, ICON, Premier Research, HILLROM, TÜV SÜD, Castor EDC, and Medrio, who share their knowledge on MDR compliance, the impact of Brexit, and the importance of clinical evaluations.

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In Vitro Diagnostic Medical Device Regulations Active Implantable Medical Devices Directive Medical Devices Directive EU Medical Device Regulation Regulatory Compliance Clinical Evaluations

Simon Thompson is a journalist based in Los Angeles, United States of America. Specialize in entertainment - film, TV and music - working extensively across TV, digital, radio and print. Works with, or has worked with E! News, Reuters, BBC, Forbes, ITN, Sky News, Euronews, 5 News, RTL, Al Jazeera, ...

Share price catalysts en route for this bargain fund

24 Feb 2025  |  www.investorschronicle.co.uk  |  English  |  Medical Devices

Crystal Amber, a leading UK small-cap closed-end fund, has reported a significant update on its major investment in Morphic Medical, which constitutes a substantial portion of its net asset value. Morphic Medical, based in Massachusetts, has developed an innovative medical device, Reset, aimed at treating uncontrolled type 2 diabetes and obesity by mimicking gastric bypass surgery. This development addresses a critical health issue affecting billions globally, with a potential to significantly impact the market.

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Medical Devices Investment Diabetes Treatment

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Emma Woollacott is a journalist based in Oxford, United Kingdom, writing in fields from science and tech to business and politics, freelance since 1992. I've written for most British broadsheet national newspapers, including the Times, Daily Telegraph, Financial Times and Guardian, as well as many ...

U.K. Pledges Action On ‘Biased’ Medical Devices

12 Mar 2024  |  Forbes  |  English  |  Medical Devices

The U.K. government is addressing biases in medical devices, particularly those using AI, following an independent report highlighting issues in devices like pulse oximeters and polygenic risk scores. The report found that these biases could lead to misdiagnoses and delayed treatments, especially for ethnic minorities and women. The government plans to update guidelines and improve data transparency, while experts call for an expert panel to oversee AI's impact on healthcare equity. The response has been positively received by medical experts and campaign groups, though caution is advised in implementing changes.

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Medical Devices AI Bias Healthcare Inequality

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