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Home » Topics » Medical devices and technologies » Software

Software
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3d-colored head and neck muscle anatomy

Singular Health joins JV for East Asia expansion of its 3D software, printing solutions

March 8, 2022
By Tamra Sami
Singular Health Group Ltd. entered a 50-50 joint venture in Macau that will explore the potential of Singular’s Scan to Surgery software for the East Asian market, which the company has long seen as a key opportunity for its 3D software and medical 3D printing ambitions.
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Laptop displaying FDA logo

Stakeholders prod FDA to include drugs in scope of device software functions guidance

Feb. 10, 2022
By Mark McCarty
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.
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Screenshot of surgical video demonstrating Rsip Vision's virtual measurement technology

Rsip Vision presents intra-op virtual measurements for laparoscopic and robot-assisted surgeries

Jan. 31, 2022
By David Ho
Israel and U.S.-based Rsip Vision Ltd. has released a new supporting technology for intraoperative video analysis. The company says its offering provides real-time and accurate anatomical measurements in surgical videos. This supports a variety of clinical use cases, such as bariatric surgery and small bowel resection.
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Cloud/cybersecurity illustration

IV pumps top list of medical devices still vulnerable to cybersecurity threats

Jan. 24, 2022
By Mark McCarty
Cybersecurity challenges can represent an existential threat to patients on medical devices, and a new report by New York-based Cynerio Inc. highlights some of those challenges. One of the findings in the report is that nearly three-fourths of intravenous pumps, which make up 38% of a hospital’s internet of things (IoT) footprint, are vulnerable to an attack, a predicament that continues to put desperately ill patients in jeopardy.
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Australian flag on laptop screen with health professional

TGA issues guidance on software requirements for COVID-19 rapid antigen self-tests

Jan. 12, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
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Concept of business partnership

Trajan acquires Axel Semrau lab automation and chromatography business for $18.7M

Nov. 24, 2021
By Tamra Sami
PERTH, Australia – Medical device and analytics company Trajan Group Holdings Ltd. has acquired the business and manufacturing facilities of Axel Semrau GmbH & Co., based in Sprockhövel, Germany, for AU$26 million (US$18.7 million), expanding the company’s global operations. Axel Semrau develops and manufactures laboratory automation and chromatography software and detection systems. The acquisition is the company’s most significant to date and broadens the company’s manufacturing base in Europe, Trajan founder and CEO Stephen Tomisich told BioWorld.
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Screenshot of DeepECG software

Vuno bags its third South Korean breakthrough designation for ECG analysis software

Nov. 18, 2021
By Gina Lee
Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld.
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3D illustration of heart cross section
TCT 2021

Stents, FFR software take a hit in study comparing PCI with coronary artery bypass

Nov. 4, 2021
By Mark McCarty
Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.
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Clinical data illustration

Activ Surgical eyes commercial launch in 2022 for digital surgery platform

Nov. 4, 2021
By Catherine Longworth
Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.
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Cancer diagnostic illustration

Asahi uses Hexagon’s Marc software for devices that carry markers to cancer vicinity

Nov. 1, 2021
By David Ho
Asahi Intecc Co. Ltd. is tapping Hexagon Manufacturing Intelligence Inc.’s non-linear structural analysis software, Marc, to develop delivery devices that carry markers to the vicinity of cancers in preparation for endoscopic surgery.
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