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BioWorld - Thursday, June 18, 2026
Home » Topics » Diagnostics, Medical technology

Diagnostics, Medical technology
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Digital illustration of U.S., coronavirus

US promises surge in at-home COVID-19 tests, but can companies deliver?

Dec. 21, 2021
By Mark McCarty
As the Omicron variant of COVID-19 sweeps across the globe, the Biden administration has announced a program to purchase 500 million rapid antigen tests to help slow the pandemic. The news comes at an especially critical time, given the increased transmissibility of the Omicron variant, but the promised volume is unlikely to be achieved by the first day of January 2022.
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Patient using Predictix Genetics on tablet
A look back as we head into 2022

Top Med-tech Trends of 2021: Better therapy matching brings optimism to depression treatment

Dec. 21, 2021
By Annette Boyle
2021 may mark the beginning of a new phase in treatment of depression. While genetic matching of depression therapies to patients has been touted for a decade, meta-analyses have not supported claims of improved response rates with studies often finding that any improvements seen likely came from switching patients to guideline-recommended therapies rather than any insight from genetics.
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Delay in IVDR affirmed by European Parliament, European Council

Dec. 21, 2021
By Mark McCarty
The effect of the COVID-19 pandemic on the roll-out of European Union’s new med-tech regulations has sparked concerns about in vitro diagnostic availability, but relief from compliance deadlines has now been achieved. The European Parliament and the European Council have agreed to ease the compliance dates of the In Vitro Diagnostic Regulation (IVDR).
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Nec partners with Bostongene to bring tumor analysis tests to Japan

Dec. 21, 2021
By Gina Lee
Nec Corp. has inked a global partnership agreement with Bostongene Corp. that will bring the latter’s Bostongene Tumor Portrait Tests to Japanese patients. Japan is the first market outside of the U.S. for the tests, according to the companies.
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British pound symbol

Bond Digital Health to expand digital lateral flow tool beyond COVID-19

Dec. 21, 2021
By Catherine Longworth
Bond Digital Health Ltd. landed £1 million (US$1.3 million) from investors to expand development of its Transform data management system for lateral flow diagnostic tests. The technology connects to an app that captures data from lateral flow assays in self-testing settings. The results are then shared to a dashboard that can be monitored by the platform admin. The new investment included equity funding from the Development Bank of Wales and high-net-worth investment service Wealth Club. In addition to the current round, Bond is aiming to raise a further £500,000 by January.
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US can now rely on stable supply of critical medical isotope

Dec. 21, 2021
By Mari Serebrov
The U.S. hit a milestone this week in ensuring a stable domestic supply of molybdenum-99 (Mo-99), a medical isotope critical to radiopharmaceuticals that are used in more than 40,000 diagnostic procedures in the U.S. each day.
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Cancer cell, DNA illustration

Viome study supports new saliva-based biomarker for oral cancer

Dec. 17, 2021
By Annette Boyle
A recently published study demonstrated that Viome Life Science Inc.’s metatranscriptomic signature for oral cancer identified the malignancy from samples of saliva with more than 90% accuracy. The mRNA platform received breakthrough device designation from the FDA in May for both early-stage oral squamous cell carcinoma and oropharyngeal cancer.
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Swoop being used on a patient

Hyperfine’s MRI ‘swoops’ into Canadian market following Health Canada approval

Dec. 17, 2021
By David Godkin
TORONTO – Hyperfine Inc. has received Health Canada approval for the first FDA-cleared portable magnetic resonance imaging (MRI) device, which also features advanced reconstruction deep learning software. The company simultaneously announced its commercial launch of the Swoop imaging system in Canada.
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Person checking Scanwatch on wrist
A look back as we head into 2022

Top Med-tech Trends of 2021: Move over Chevy, smartwatches take the heartbeat of America now

Dec. 16, 2021
By Annette Boyle
This year saw continued advances in smartwatches as they increasingly move from wellness assistants to medical monitors. Nowhere has that been clearer than in cardiovascular health, where multiple wearables now allow users to quickly detect atrial fibrillation, a notoriously shy condition previously only detectable in early stages by chance in a physician’s office or by wearing a cumbersome Holter monitor for 24 to 48 hours.
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Virgile Barret-Vivin and Alexis Saintamand with endoscopy tech

Dyameo raises $1.13M to bring endoscopy probe for in vivo cancer diagnosis to market

Dec. 16, 2021
By Bernard Banga
PARIS – Dyameo SAS has successfully raised $1.13 million in seed funding to develop its endoscopy probe used for the instantaneous detection of cancerous cells. This round was led by  Medevice SAS and Aquiti Gestion SAS via its co-investment fund, NACO.
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