BREAKTHROUGH DIAGNOSTIC
BREAKTHROUGH DIAGNOSTIC
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Investments List
| Date | Company | Article | Money raised |
|---|---|---|---|
| 2019-12-24 | Durin Technologies | Breakthrough Diagnostic investment in Venture Round - Durin Technologies | 3.5 M USD |
More informations about "Breakthrough Diagnostic"
From Concept to Market: How the FDA’s …
Mar 3, 2025 by Sruthi Sundaram, PhD The Breakthrough Devices Program by the FDA is designed to expedite the review and development of medical devices and in vitro diagnostics (IVD) that may provide a more effective … See details»
Updated Final Guidance on Breakthrough Devices …
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening ... See details»
Breakthrough T1D Canada
Jun 2, 2025 Breakthrough T1D Canada is the leading organization in funding research for Type 1 Diabetes, with an aim to end T1D worldwide. ... Jim Beatty – navigating an adult diagnosis in … See details»
Roche granted FDA Breakthrough Device …
Apr 29, 2025 This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology. Basel, 29 April 2025 - … See details»
FDA gives AI-powered blood test for obstructive CAD …
May 13, 2025 “The FDA’s breakthrough device designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive CAD,” added Rhonda Rhyne, … See details»
Breakthrough Device Designation Consultants - MCRA
When combined with MCRA’s long history and deep expertise in navigating the review process for hundreds of US FDA submissions ranging from 510(k)s to PMAs for first-in-class medical … See details»
FDA Breakthrough Device Designation for blood …
1 day ago The FDA’s drive to accelerate access to new medical device technologies continues, with a new product from 3i Diagnostics receiving a Breakthrough Device Designation. While the US regulator ... See details»
Beckman Coulter Receives FDA Breakthrough …
BREA, CALIF., January 28, 2025 — Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to … See details»
Breakthrough Device Designation - blog.greenlight.guru
Organization experienced in getting products approved and on the market. We know your needs. We know the pitfalls of the submission process and how to avoid them. From regulatory … See details»
FDA Breakthrough Device Designation: Fast-Track …
Mar 24, 2025 The Breakthrough Devices Program is an initiative by the U.S. Food and Drug Administration (FDA) to accelerate the development and review of medical devices that provide more effective treatment or … See details»
Early experience with the FDA’s Breakthrough Devices program
Jul 23, 2020 The remainder were diagnostic devices approved or cleared via the PMA (n = 1; 7.7%) or De Novo (n = 3; 23.1%) pathways, with indications for use including next-generation … See details»
Organizing for breakthrough innovation | McKinsey - McKinsey
Jan 1, 2016 Severin Schwan: Looking back over the past 100 or more years, all our periods of strongest growth were driven by breakthrough innovations. This started off with medicines like … See details»
Breakthrough Diagnostic - Crunchbase Investor Profile
Breakthrough Diagnostic is a health care Company. 142,999; Highlights. Investments 1. Similar Companies 3. Recent News & Activity. Funding Round ... See details»
Moving the dial on diagnostics: an update from the Lancet …
May 20, 2025 The intersection of diagnostics, AI, and digital tools offers new opportunities: some have termed this connected diagnostics, defined by one observer as: “Connected diagnostics … See details»
Roche granted FDA Breakthrough Device Designation for first AI …
Apr 29, 2025 This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in … See details»
Roche receives FDA breakthrough device designation for digital ...
May 1, 2025 The biotech company Roche is receiving support towards its efforts to advance cancer diagnosis and digital pathology Open Access Government Open Access ... as the U.S. … See details»
This tiny patch could replace biopsies—and ... - ScienceDaily
2 days ago Biopsies are among the most common diagnostic procedures worldwide, performed millions of times every year to detect diseases. ... The breakthrough was possible through … See details»
Roche AI diagnostic approved - Medthority
Apr 30, 2025 “This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” said Matt … See details»
Roche granted FDA Breakthrough Device Designation for first AI …
May 20, 2025 This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in … See details»
Breakthrough diagnostics: The new eyes and ears of healthcare
Mar 3, 2021 Feelix is a nextgen diagnostic device that records sound and uses embedded AI to diagnose lung disease. Its accuracy rate is a staggering 91%, compared to the 75% accuracy … See details»