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BioWorld - Monday, January 19, 2026
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Synaptive Medical announces close of $25M preferred share financing to expand global footprint

Dec. 10, 2019
By David Godkin
TORONTO – Synaptive Medical Inc. has completed the first round of a new preferred equity investment totaling $25 million led by Guelph-Ontario-based Linamar Corp., which also entered into a manufacturing agreement with Synaptive, and Calgary’s Audible Capital Corp.
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Viewray sees an additional $139M with collaborations with Elekta, Medtronic

Dec. 6, 2019
By Annette Boyle
As part of newly announced collaborations with Cleveland-based Viewray Inc., Elekta AB assumed a 9.9% stake in the company, and Medtronic plc also made a minority investment. The company's largest shareholder, Fosun International Ltd., also led the round. "In total, the company raised approximately $139 million, net of fees," Viewray President and CEO Scott Drake told BioWorld MedTech.
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Akoya Biosciences rakes in $50M to back CODEX, Phenoptics platforms

Dec. 5, 2019
By Liz Hollis
Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology.
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Akoya Biosciences rakes in $50M to back CODEX, Phenoptics platforms

Dec. 5, 2019
By Liz Hollis
Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology.
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FDA gives 510(k) nod to Moleculight’s wound assessment device

Dec. 5, 2019
By Meg Bryant
Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.
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Bioworld MedTech’s Diagnostics Extra for Dec. 5, 2019

Dec. 5, 2019
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics.
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PGDx receives IDE approval to support Merck’s precision oncology trial

Dec. 4, 2019
By Liz Hollis
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.
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PGDx receives IDE approval to support Merck’s precision oncology trial

Dec. 4, 2019
By Liz Hollis
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
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Veracyte seeks wider diagnostics footprint with Nanostring licensing deal

Dec. 4, 2019
By Meg Bryant
Genomic testing firm Veracyte Inc., of South San Francisco, has inked a definitive agreement with Seattle-based Nanostring Technologies Inc. for the global rights to Nanostring’s Ncounter platform. The deal – for $50 million in cash and Veracyte stock, plus up to $10 million in potential milestone payments – will allow Veracyte to develop and commercialize diagnostic tests on Nanostring’s Ncounter Flex system.
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Ultra-microcap Endra aims to launch affordable NAFLD/NASH diagnostic imaging tool in 2020

Dec. 4, 2019
By Stacy Lawrence
Ann Arbor, Mich.-based startup Endra Life Sciences Inc. started out focused on a photoacoustic imaging tool for mice in the lab, but in recent years it has shifted gears. Now, it aims to secure the go-ahead next year from European and U.S. regulators to launch a thermo-acoustic enhanced ultrasound system designed to quantitatively assess liver fat, known as TAEUS.
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