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Home » Topics » Medical devices and technologies » Software

Software
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Patent gears

Informal three-part test may aid in sustaining subject matter eligibility

Feb. 16, 2021
By Mark McCarty
The problem of patent subject matter eligibility is still a nightmare for companies in the diagnostics space, but patent attorney Michael Borella said this is still an issue for software as well. Borella said there are three characteristics that should be considered while drafting patent claims – specificity, technical character and novelty – to arrive at a reasonable assurance that that the key claims in a patent application will survive a challenge in hazardous legal environs, such as the Court of Appeals for the Federal Circuit.
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Map of Australia as blue circuit board, digital network

Australia releases new regulations on software-based medical devices

Jan. 22, 2021
By Tamra Sami
PERTH, Australia – Following consultation with medical device stakeholders in 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The new rules that go into effect on Feb. 25, 2021, clarify the boundary of regulated software products, introduce new classification rules, and provide updates to the essential principles for software-based medical devices.
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Hand holding FDA blocks

Computer system validation problem bubbles to the surface

Jan. 7, 2021
By Mark McCarty
Computer system validation (CSV) has been the source of considerable drag on device makers’ efforts to realize value derived from investments in the company’s technology base, but this long-standing issue is finally drawing some much-needed attention.
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Software screenshot

Rsip Vision develops algorithmic module for heart function assessment

Dec. 31, 2020
By David Ho
HONG KONG – A new algorithmic module developed by Rsip Vision Ltd. makes it possible to generate automated expert-level assessment of heart functions, facilitating quick and reliable detection of cardiac illness and heart attacks.
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The 3 steps for getting visual field defects checked by Heru

Heru registers AI vision test with FDA, begins commercialization pilot

Dec. 28, 2020
By Mary Ellen Schneider
Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.
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Laptop, stethoscope, medical icons, health professional

FDA’s digital health checklist for 2021 crammed full of delayed priorities

Dec. 10, 2020
By Mark McCarty
The COVID-19 pandemic has been more than just a distraction for the U.S. FDA, which started 2020 with a number of ambitions regarding digital health regulation. Despite having unveiled the Digital Health Center of Excellence to great fanfare, the agency is struggling to wrap up major digital health programs, such as the precertification program for software as a medical device, leaving the FDA with a daunting agenda for digital health in the coming year.
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Software screenshot

Paige obtains CE marks for breast, prostate cancer options

Dec. 9, 2020
By Liz Hollis
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
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AI microchip illustration

Aidoc wins clearance for first AI triage solution in incidental pulmonary embolism

Oct. 23, 2020
By Mary Ellen Schneider
Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours.
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Coronavirus, lungs, hand holding stethoscope

Nec partners with Oslo University Hospital to develop AI-based diagnostic for COVID-19

Oct. 16, 2020
By Elise Mak
Nec Corp.’s bioinformatics subsidiary Nec Oncoimmunity AS said it is working with Oslo University Hospital to develop an artificial intelligence (AI) platform that will allow the team to design a T-cell diagnostic to complement the current serological tests for infectious diseases, including COVID-19.
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Steadying hand while reaching for glass

New screening tool locks on to Parkinson’s disease psychosis

Sep. 14, 2020
By David Godkin
TORONTO – Most doctors recognize the symptoms instantly: hand tremors, slurred speech, impaired posture and balance. What they don’t always associate with people suffering from Parkinson’s disease are hallucinations and delusions.
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