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BioWorld - Thursday, June 19, 2025
Home » Topics » Medical devices and technologies » Software

Software
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Neurophet Aqua

Neurophet wins FDA nod for brain AI software, targets US expansion

Nov. 25, 2024
By Marian (YoonJee) Chu
On the heels of U.S. FDA approval for Neurophet Aqua, an updated version of its artificial intelligence (AI)-based magnetic resonance imaging analysis software for the brain, Neurophet Inc. is preparing for an IPO in 2025 and expansion into U.S. and European markets.
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AI biotech research concept with lightbulb and digital background
2024 Med Tech Conference

CBO scoring impedes expanded Medicare digital benefit categories

Oct. 16, 2024
By Mark McCarty
The U.S. Medicare program has a notorious problem with regard to coverage of digital products and software as a service, but the agency is dependent on Congress to add new benefit categories via legislation.
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HealthCCSng

Nanox software cleared for coronary artery calcification measurement

Aug. 27, 2024
By Shani Alexander
The clearance by the U.S. FDA of Healthccsng V2.0, an artificial intelligence cardiac solution developed by Nano-x Imaging Ltd.’s (Nanox) subsidiary, Nanox.AI, is highly “significant” for the company and will offer “substantial” benefits to cardiology departments by significantly enhancing the detection of coronary artery calcification, Erez Meltzer, Nanox CEO told BioWorld.
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Blood cells and bacteria

Algodx receives FDA clearance for early sepsis detection software

Aug. 21, 2024
By Shani Alexander
Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.
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Neudive
Patents

Neudive files IP for new digital therapeutic neurodiverse patients

July 12, 2024
By Simon Kerton
The first patenting from South Korea’s Neudive Inc. sees its CEO, SungJa Cho, applying for protection of the company’s mobile digital social therapy device, NDTx-01, which helps build the social skills of neurodiverse individuals, and in particular children and adolescents with autism spectrum disorder and social communication disorder.
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Patients-training-with-CUREosity-device-25june24.jpg

Cureosity raises €3.8M to expand use of virtual reality therapy

June 25, 2024
By Shani Alexander
Cureosity GmbH has raised €3.8 million (US$4.1 million) in growth financing to expand the use of its virtual reality therapy which promotes the sensorimotor and cognitive rehabilitation in patients who have suffered a stroke or with neurodegenerative diseases. The funding came from existing and new investors including Techvision Fonds and Nomainvest, a Belgian family office.
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Adult Endeavor

Akili’s Endeavor FDA cleared for OTC use in adults with ADHD

June 19, 2024
By Annette Boyle
After a rocky year, Akili Inc. received U.S. FDA clearance for use of its non-prescription product, Endeavorotc, for treatment of adults with attention deficit/hyperactivity disorder (ADHD). Endeavorotc employs a video game format to improve attention in individuals with inattentive or combined-type ADHD.
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Website of The Federal Trade Commission

US FTC’s breach notification draws fire from dissenting commissioners

May 2, 2024
By Mark McCarty
The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR.
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Vicore digital therapy app

Vicore receives breakthrough device designation for lung disease digital therapy

March 20, 2024
By Shani Alexander
Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB.
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OBT app
Patents

Dr. Pfleger Arzneimittel develops digital companion app for overactive bladder

Jan. 8, 2024
By Simon Kerton
Dr. Pfleger Arzneimittel GmbH is seeking patent protection for a system and a corresponding computer program product for assisting in alleviating overactive bladder syndrome and incontinence symptoms, particularly reduction of micturitions and reduction of urine loss. The system is particularly suited for being implemented and distributed as a smartphone app which may be operated by the user.
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