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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.Ai, Ihealthscreen, Medtronic.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognoa, Edwards, Sorrento.
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.
Becton, Dickinson & Co. (BD) is looking to ease the burden on microbiology labs with the U.S. launch of its urine culture analysis imaging application by automating microbiology processes. Powered by artificial intelligence (AI), the app is intended for use on the device manufacturer’s Kiestra lab automation incubation and imaging system.
Hematologists juggle two competing needs, and often multiple lenses, to really see what’s happening in a blood sample. Essentially, they need to see both the veins on an individual leaf and the forest, but lack a digitized system that can provide images of both. Scopio Labs Ltd.’s recently FDA-approved X100 with Full Field Morphology Peripheral Blood Smear (FFM-PBS) application addresses this need by combining computational photography imaging with artificial intelligence tools.
Aktiia SA’s cuff-less blood pressure monitor – a connected optical system for continuous monitoring – has launched in Austria, France, Germany, Ireland, U.K. and Switzerland. Aktiia’s monitor is a bracelet that includes a photoplethysmography sensor with a silicon diode receptor capable of measuring the pulse to within an accuracy of ±5 beats per minute, a communication module and a rechargeable lithium-ion battery.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Advanced Human Imaging, Avicenna.AI, Lantheus, Micro Interventional Devices, Nowdiagnostics.