Software

FDA updates cybersecurity guidance for medical devices

Wed, 04 Feb 2026 11:00:00 -0500

The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.

Seluna launches study to validate sleep diagnostic software

Fri, 29 Aug 2025 12:00:00 -0400

Seluna Ltd. launched a clinical study to validate its sleep diagnostic software, designed to support doctors to rapidly diagnose childhood sleep disorders and prioritize treatment for those who urgently need it. The study follows Seluna’s recent securing of nearly £650,000 (US$875,000) in funding.

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

Mon, 25 Nov 2024 11:00:00 -0500

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.

CBO scoring impedes expanded Medicare digital benefit categories

Wed, 16 Oct 2024 12:00:00 -0400

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.

Nanox software cleared for coronary artery calcification measurement

Tue, 27 Aug 2024 12:00:00 -0400

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.

Algodx receives FDA clearance for early sepsis detection software

Wed, 21 Aug 2024 12:00:00 -0400

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.

Neudive files IP for new digital therapeutic neurodiverse patients

Fri, 12 Jul 2024 12:00:00 -0400

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.

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

Tue, 25 Jun 2024 12:00:00 -0400

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.

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

Wed, 19 Jun 2024 12:00:00 -0400

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.

US FTC’s breach notification draws fire from dissenting commissioners

Thu, 02 May 2024 12:00:00 -0400

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.

Vicore receives breakthrough device designation for lung disease digital therapy

Wed, 20 Mar 2024 12:00:00 -0400

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.

Dr. Pfleger Arzneimittel develops digital companion app for overactive bladder

Mon, 08 Jan 2024 11:00:00 -0500

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.

Neurophet nets ₩20B from financing, slates Kosdaq IPO for 2024

Mon, 13 Nov 2023 11:00:00 -0500

Neurophet Inc. pulled in ₩20 billion (US$15.1 million) in its series C funding round, helping roll out its AI-software suite for neurodegenerative diseases worldwide and prep its IPO on the Kosdaq which is scheduled to take place sometime in 2024.

Brainaurora files for Hong Kong IPO to develop digital therapeutics

Tue, 22 Aug 2023 12:00:00 -0400

Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive impairment, as well as the largest company in China in terms of revenue from the commercialization of cognitive impairment DTx products in 2022.

FDA’s final guidance for device software functions tightens requirements for anomalies

Wed, 09 Aug 2023 12:00:00 -0400

The U.S. FDA’s final guidance for premarket submissions for device software functions serves as a much needed overwrite of a badly outdated policy but includes some significant changes over the legacy guidance. There are also a few changes between the 2021 draft and the 2023 final guidance, however, such as a call for more details about how software anomalies were discovered and what a root cause analysis would suggest about the origin of the anomaly.

FDA breathes life into Etiometry’s algorithm for neonatal hypercapnia risk

Thu, 03 Aug 2023 12:00:00 -0400

Premature babies face challenges in the neonatal intensive care unit (NICU) as their heart, lungs and neurological system continue to develop outside the womb. Roughly half of neonates born at 26 weeks to 28 weeks gestation experience respiratory distress. These infants often need extra oxygen and help breathing, as well as constant monitoring to ensure oxygen is absorbed and carbon dioxide (CO₂) is dispelled. To that end, Etiometry Inc. received FDA clearance for its IVCO2 Index, a software tool for use in monitoring risk of hypercapnia in NICU patients weighing less than 2 kg.

Art Medical’s nutritional management platform improves ICU feeding efficiency

Wed, 26 Jul 2023 12:00:00 -0400

Art Medical Ltd. released data from a study which demonstrated that its Smart+ Platform can maximize feeding efficiency and improve patient outcomes by reducing both ICU length of stay and the length of time on a ventilation by approximately three days. ICU complications related to nutrition pose significant challenges in critical care.

FDA’s guidance for clinical decision support draws second request for withdrawal

Fri, 14 Jul 2023 12:00:00 -0400

The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF). Barbara Evans of the UF School of Law asserted that the CDS final “raises constitutional issues” that are of sufficient importance to warrant an investigation led by the FDA commissioner’s office because of what she argues is a disregard for the First Amendment encoded in the guidance.

Sonio raises $14M to deploy prenatal screening solution in the US

Thu, 13 Jul 2023 12:00:00 -0400

Sonio SAS closed its series A fundraising round raising $14 million that will go some way in helping the company deliver on its mission to improve access to quality pregnancy monitoring for women everywhere through its software-as-a-service (SaaS) platform. Sonio has developed an artificial intelligence (AI) prenatal screening solution that automates ultrasound reporting while providing image quality control and detection of potential anomalies. The capital raise was led by Cross-Border Impact Ventures, a North American impact fund dedicated to the health of women and children.

JAMA authors see problems with failures to acknowledge the use of AI in medical devices

Mon, 10 Jul 2023 12:00:00 -0400

Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.

Thirona secures $2.73M in funding from EIC for AI-based lung platform

Fri, 07 Jul 2023 12:00:00 -0400

Thirona BV has been awarded $2.73 million in funding from the European Innovation Council (EIC) to fast-track the development of its artificial intelligence (AI)-based lung platform to analyze chest CT imaging. In competition with 554 other submissions, Thirona was one of 51 innovative technology companies awarded the EIC accelerator program grant, the total budget for which is €261 million (US$286.28 million) in 2023.

Resmed buying respiratory diagnostics software company Somnoware

Fri, 07 Jul 2023 12:00:00 -0400

Resmed Inc. has acquired Somnoware Inc., a privately held developer of respiratory care diagnostics software, for an undisclosed price. The deal is Resmed’s third software acquisition in the past year, having snapped up German software-as-a-service (SaaS) maker Medifox Dan GmbH for $1 billion in June 2022 and Mementor GmbH last August.

Luminopia lands $16M series A for pediatric eye treatment

Fri, 30 Jun 2023 12:00:00 -0400

Luminopia Inc. reeled in $16 million in an oversubscribed series A financing led by U.S. Venture Partners. The funds will support full commercial launch of the company’s U.S. FDA-cleared digital therapeutic for the treatment of children ages 4-7 with amblyopia. “We are thrilled to announce the successful close of our oversubscribed series A round, which will allow us to advance our mission of pioneering a new class of treatments for the 15 million Americans who suffer from neuro-visual disorders,” said Scott Xiao, Luminopia’s co-founder and CEO.

Maker of orthodontic planning software snares FDA warning for software validation lapse

Wed, 28 Jun 2023 12:00:00 -0400

Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.

FDA, industry coalition still at odds over September 2022 CDS final guidance

Fri, 09 Jun 2023 12:00:00 -0400

The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.

Sparrow’s smartphone stethoscope gets FDA nod

Wed, 07 Jun 2023 12:00:00 -0400

The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.

FDA grants Aural Analytics breakthrough device designation

Wed, 29 Mar 2023 13:00:00 -0400

Aural Analytics Inc. received a breakthrough device designation from the U.S. FDA for its Speech Vitals-ALS technology, a software application that collects and analyzes speech recordings to help monitor amyotrophic lateral sclerosis (ALS) in adults in clinic and home settings. The software could improve management of the devastating disease.

Nervtex’s movement disorders diagnostic assessment software gets NMPA approval

Tue, 17 Jan 2023 13:00:00 -0500

Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state.

Reflexion inks deal with Mirada to improve personalized cancer treatment

Thu, 14 Jul 2022 13:00:00 -0400

Reflexion Medical Inc. entered into a nonexclusive worldwide licensing agreement with Mirada Medical Ltd., allowing Mirada’s Redengine image registration algorithms to be integrated into Reflexion’s X1 treatment planning software. The algorithms align a patient’s anatomy between distinct imaging modalities or between radiotherapy treatments.

Infervision receives nod for AI-powered CT reader in China

Wed, 13 Jul 2022 13:00:00 -0400

Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.