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.

The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see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.

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.

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.

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.

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.

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.

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.

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.

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.