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BioWorld - Friday, December 19, 2025
Home » Topics » Europe, BioWorld MedTech

Europe, BioWorld MedTech
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Sava Biosensor

Sava raises $19M for multi-molecule biosensor

Aug. 1, 2025
By Shani Alexander
Sava Technologies Ltd. raised $19 million in a series A funding round for its multi-molecule biosensor platform that can detect biomarkers just beneath the skin, in real-time. The funds will go towards its first product, a continuous glucose monitor, which early clinical data showed can generate accurate glucose readings for up to 10 days of continuous wear.
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Pills and percentage sign

Industry looking to adapt under shadow of US Rx tariffs

Aug. 1, 2025
By Mari Serebrov
No Comments
While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.
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Hand, stylus pointing at graph on screen

Rebound continues as med tech raises $8.13B in Q2

July 29, 2025
By Amanda Lanier
Med-tech companies raised $8.13 billion in the second quarter of 2025, a modest dip from the $8.32 billion recorded in Q1. While the quarterly total marks a continued improvement over 2023’s lower figures, it still lags behind pre-pandemic peaks and the $22.87 billion raised in 2Q20. Compared to 2Q24’s $7.49 billion, this year’s figure reflects a slight year-over-year gain.
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Intracept RF Generator and Intracept RF Probe

Boston Sci offers new neuromod treatments to European patients

July 29, 2025
By Shani Alexander
Boston Scientific Corp. received CE mark certification under the Medical Device Regulation for its Intracept intraosseous nerve ablation system, bringing another treatment option to patients with chronic pain.
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Trinity CGM+

Trinity unveils AI-powered CGM+ biosensor

July 28, 2025
By Shani Alexander
Trinity Biotech plc recently unveiled CGM+, an AI-native, wearable biosensor that goes beyond traditional continuous glucose monitors and tracks glucose levels, cardiovascular activity and body temperature at the same time. The company believes that as precision medicine becomes central to health care, especially with the collection of real-time data, CGM+ will become a critical enabler of AI-based diagnostics, behavioral coaching and chronic disease management.
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Tinted Euro symbol

EU approves €403M package for med tech

July 25, 2025
By Shani Alexander

 The European Commission approved up to €403 million ($472 million) in funding to support development of innovations in medical devices in the region. The funds will go towards 10 companies that incorporate novel digital and AI features into their solutions.


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Roche building

Roche receives CE Mark for Alzheimer’s rule out test

July 24, 2025
By Shani Alexander
Roche Holding AG received CE mark for its Elecsys pTau181 test to help rule out Alzheimer’s disease. The minimally invasive blood test, developed in collaboration with Eli Lilly and Co., measures phosphorylated Tau 181 protein, a biomarker indicative of amyloid pathology, a hallmark of Alzheimer’s.
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Gears with regulatory words

MDCG guidance highlights hazards of modifications in IVD studies

July 23, 2025
By Mark McCarty
New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies.
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Plexaa Bloom43

Plexāā Bloom43 to transform breast reconstruction surgery

July 22, 2025
By Shani Alexander
Plexāā Ltd. recently raised $4.5 million to support the upcoming U.S. launch of Bloom43, its wearable device that helps patients prepare for breast cancer surgery and reconstruction by using a technique called supraphysiological preconditioning.
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MHRA logo

MHRA eyes expanded reliance programs to boost patient access

July 22, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency unveiled another round of measures designed to promote access to the latest medical technology, which includes a move to jettison domestic device markings in favor of unique device identifiers.
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