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BioWorld - Friday, June 19, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Regulatory actions for June 10, 2021

June 10, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Avita Medical, Canon Medical, Desktop Health, Medtronic, Neurescue, Nuvo Group.
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Regulatory actions for June 9, 2021

June 9, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cymedica Orthopedics, Ibex, Subtle Medical.
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Emeric Lemaire, Corneliu Malciu and Theo Ryffel

Arkhn raises $5M to lead health care institutions towards sovereignty over efficient data management

June 8, 2021
By Bernard Banga
PARIS – Arkhn SAS has finalized a $5 million seed round to help drive health care institutions towards secure and efficient data management. This financing round has been led jointly by the two French venture capital firms, Kurma Partners SA and Newfund SA, though their respective funds Kurma Diagnostics II and Newfund II.
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Smartfuse TLIF cage prototype

Intelligent Implants scores FDA breakthrough nod for orthopedics platform

June 7, 2021
By Meg Bryant
Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions.
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Smartphone app shows temperature readings from injected chip

Swedish startup’s injectable chips accurately track body temperature

June 4, 2021
By Meg Bryant
Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.
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Regulatory actions for June 3, 2021

June 3, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.Ai, Ihealthscreen, Medtronic.
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U.S. intellectual property illustration

Alivecor takes patent dispute with Apple to ITC

June 2, 2021
By Mark McCarty
Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.
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Acumen HPI software screenshot

FDA OKs Edwards’ HPI software with noninvasive Acumen IQ cuff

June 2, 2021
By Meg Bryant
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.
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Regulatory actions for June 2, 2021

June 2, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognoa, Edwards, Sorrento.
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French flag composed of binary code

France is beefing up its e-health public sector investment fund, which now stands at $120M

June 1, 2021
By Bernard Banga
PARIS – French public sector investment bank Bpifrance SA is consolidating its commitment to e-health startups, with the announcement of a doubling in size of its Fonds Patient Autonome [Patient Independence Fund] to more than $120 million. Three further partners from France have also subscribed to this new fund. These are the Banque des Territoires – an offshoot of the French national public sector savings and investment fund, Caisse des Dépôts et Consignations; the Harmonie Mutuelle insurance group; and the foundation hospitals Groupe Vivalto Santé SA.
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