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BioWorld - Friday, May 8, 2026
Home » Topics » Medical devices » Digital health

Digital health
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A model of a 3D segmented scoliosis spine

Singular Health teams up with CSIRO, Osteopore on AI-based patient-specific cranial implants

Oct. 27, 2021
By Tamra Sami
PERTH, Australia – Singular Health Group Ltd. was awarded AU$50,000 (US$37,000) in funding from Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) Kick-Start program to undertake a research project to develop artificial intelligence (AI)-based tools to automatically design patient-specific cranial implants. The AI will be integrated into Singular Health’s surgical planning software for editing before the cranial implants are 3D printed.
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Chain links composed of binary code

Alivecor taps blockchain technology to connect Kardiamobile users with physicians

Oct. 27, 2021
By Catherine Longworth
Alivecor Inc. is partnering with blockchain technology company Solve.Care to connect users of its Kardiamobile device to physicians through a telehealth network. Tallinn, Estonia-based Solve.Care’s blockchain platform, the Global Telehealth Exchange (GTHE), is an open global cross-border telehealth network currently available in 27 countries. Alivecor’s Kardiamobile 6L device is the first and only six-lead personal ECG cleared by the FDA. Through the partnership, Kardiamobile devices will be integrated with GTHE where physicians will be able to access a user’s electrocardiogram (ECG) reading upon their consent through teleconsultations.
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FDA icons

AI change control draft a second-tier entry in FDA guidance agenda for 2022

Oct. 26, 2021
By Mark McCarty
The FDA’s device center has posted its annual fiscal year guidance agenda, and there are several carry-over items from fiscal 2021. The most conspicuous element of the FY 2022 agenda may be that a draft guidance for change control for artificial intelligence (AI) algorithms rates an entry on the B list rather than the A list, suggesting that the draft is not likely to emerge any time in the next 12 months.
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Digital cancer cells illustration

Simbiosys secures $15M investment for Tumor Scope platform

Oct. 26, 2021
By Catherine Longworth
Precision cancer care company Simbiosys Inc. has raised $15 million to accelerate development of its Tumor Scope software platform for management of solid tumors. The application enables oncologists to virtualize cancer tumors and simulate a patient’s response to specific drug therapies by combining artificial intelligence with biophysical simulations. The technology models the impact of drug delivery, drug sensitivity, metabolism and spatial heterogeneity and provides data that can be used to inform individual treatment plans.
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Pathway Medical app on multiple tablet, smartphone screens

Investors spend C$1.6M to expand AI-driven medical decision-making platform

Oct. 22, 2021
By David Godkin
TORONTO – Pathway Medical Inc. has raised C$1.6 million (US$1.3 million) in an oversubscribed funding round to expand its evidence-based clinical decision support platform and deliver an enterprise version of its point-of-care technology. The current mobile app uses natural language processing and machine learning to give doctors evidence-based answers to questions on patient diagnosis and treatment.
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Asia at night from space

Medtronic launches Open Innovation Platform in Singapore, along with competition and digital hub

Oct. 22, 2021
By David Ho
With the support of Singapore’s Economic Development Board (EDB), Medtronic plc has launched the Medtronic Open Innovation Platform (OIP) in Singapore to develop med-tech and digital health solutions for Asia Pacific. The company will invest up to $50 million for this venture.
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Regulatory actions for Oct. 22, 2021

Oct. 22, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter, Biomérieux, Genentech, Naviswiss, Xtrava Health.
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Gold wireframe handshake

Everly Health seals third acquisition of the year with women’s health startup Natalist

Oct. 21, 2021
By Catherine Longworth
The parent company of digital health unicorn Everlywell Inc. is expanding its portfolio of women’s health products through the acquisition of Charleston, S.C.-based startup Natalist Inc. The purchase marks Everly Health’s third acquisition of the year following agreements to buy national clinician network PWN Health and home lab testing company Home Access Health Corp. Financial terms of all deals were not disclosed. Headquartered in Austin, Texas, Everly Health will add Natalist’s suite of reproductive products to its existing tests for menopause, fertility hormones and sexual health.
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Wireframe hands, coins

X-trodes raises $4.5M for wearable wireless technology

Oct. 19, 2021
By Catherine Longworth
X-trodes Ltd. has raised $4.5 million to develop its portfolio of wearable smart technologies that measure and analyze electrophysiological signals. Tel Aviv-based X-trodes is developing two products – a wireless system “Smart Skin” for sleep monitoring and a wearable system to prevent muscle injuries and accelerate recovery. The core technology is based on an intellectual property (IP) developed in the nanotechnology laboratory of Tel Aviv University.
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AI silhouette

Aaronson says demographic representation in AI is important, but clinical validation is the key

Oct. 18, 2021
By Mark McCarty
The question of bias in artificial intelligence (AI) algorithms is generally thought to be overcome by ensuring that the data set used to train the algorithm is representative of the population at large. However, Naomi Aaronson, executive director of clinical evaluation at the Blue Cross Blue Shield Association, said its not that simple because demographic data can combine in unpredictable ways and thus “the only real understanding of whether it works is in the clinical validation” of the algorithm in various settings.
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