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Home » Topics » Medical devices and technologies » Medical devices

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Cross section illustration of Helix device in heart

Biocardia phase III bolsters cell therapy data in heart failure

March 4, 2024
By Lee Landenberger
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial.
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Elderly woman holding illustration of brain with missing puzzle piece

Australian incubator developing drugs, devices for dementia

Feb. 27, 2024
By Tamra Sami
With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.
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Elderly woman holding illustration of brain with missing puzzle piece

Australian incubator developing drugs, devices for dementia

Feb. 26, 2024
By Tamra Sami
With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.
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WTO logo

Deadline nears with no consensus on broader WTO COVID-19 waiver

Feb. 20, 2024
By Mari Serebrov
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
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US prices of asthma, COPD inhalers under HELP microscope

Jan. 9, 2024
By Mari Serebrov
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
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Handling of scientific dissent at US FDA under the microscope

Jan. 4, 2024
By Mari Serebrov
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
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U.S. intellectual property illustration

US lawmakers: Expansion of COVID-19 IP waiver unnecessary

Jan. 2, 2024
By Mari Serebrov
Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
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Surgeons using  image guided therapy system

Theken acquires Cleveland Clinic spinout Visionair Solutions

Aug. 29, 2023
By Meg Bryant

Theken Companies LLC reported the acquisition of Visionair Solutions Inc. from the Cleveland Clinic, a deal that adds pulmonary therapy to its broad portfolio with Visionair’s 3D platform for the creation of silicon stents for central airway obstructions (CAOs). Terms of the transaction, which has officially closed, were not disclosed.


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Medtronic's Inceptiv neurostimulator

Medtronic wins CE mark for closed-loop spinal cord stimulator

Aug. 25, 2023
By Meg Bryant
The European Commission has granted CE mark approval to Medtronic plc for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). The device is the first Medtronic SCS to sense an individual’s biological cues and make adjustments in real time to control pain all day long. Dublin-based Medtronic plans to launch Inceptiv in Europe in the coming months.
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TGA revisits framework for audits for devices entering Australian market

July 26, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
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