Applied Medical broadens MiniSPC Button with new size options
Enteral and surgical devices provider Applied Medical Technology has expanded its low-profile suprapubic catheter, the MiniSPC Button, introducing new size options …
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Whoop concludes $575m fundraise, adding Abbott as strategic investor
Whoop has raised $575m, bringing the self-ascribed human performance company to a valuation of over $10bn, and adding a medtech …
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MediBeacon secures CE Mark certification for TGFR monitor and sensor
MediBeacon has received the CE Mark certification under the European Union (EU) Medical Device Regulation (MDR) for its transdermal glomerular …
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Boston Scientific presents Watchman FLX and EKOS endovascular system data
Boston Scientific has shared a duo of positive data readouts from two separate trials evaluating its Watchman FLX left atrial appendage …
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FDA clears Boston Scientific’s Asurys system for endoscopic procedures
Boston Scientific has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Asurys fluid management system, …
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Lucida Medical raises $11.4m to advance AI prostate cancer diagnostic
UK-based Lucida Medical has raised £8.7m ($11.4m) to advance its artificial intelligence (AI)-based software for prostate cancer diagnosis. VC firm IW …
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Abbott integrates Precision Oncology portfolio into Flatiron’s OncoEMR
Abbott has announced the integration of its Precision Oncology portfolio into Flatiron Health's cloud-based electronic medical record (EMR) platform, OncoEMR. The …
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EU AI Act meets MDR/IVDR: clarity or chaos?
On 16 December 2025, the European Commission (EC) published a proposal that, if adopted, will harmonise artificial intelligence (AI) Act …
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Butterfly Network strikes US first with POCUS gestational age tool clearance
Butterfly Network’s gestational age (GA) tool has secured US Food and Drug Administration (FDA) clearance, making the point-of-care ultrasound (POCUS) …
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Roche unveils cobas MPX-E assay for HIV and hepatitis viruses
Roche has launched the cobas MPX-E donor screening assay, a qualitative in-vitro diagnostic test for detecting and differentiating human immunodeficiency …
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FDA clears Medtronic’s Stealth Axis system for cranial and ENT procedures
Medtronic’s Stealth Axis surgical system has obtained US Food and Drug Administration (FDA) clearance for use in cranial and ear, nose, …
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FDA approves Anumana’s pulmonary hypertension algorithm
Anumana has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ECG-AI pulmonary hypertension (PH) detection …
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Vaxess Technologies raises $50m, rebrands to Terrestrial Bio
Vaxess Technologies has raised $50m and announced that it will now go by the name Terrestrial Bio, in a rebrand …
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Co-Diagnostics delivers PCR Pro instruments and TB kits to India
Co-Diagnostics has begun shipping its PCR Pro instruments, Co-Dx polymerase chain reaction (PCR) mycobacterium tuberculosis (MTB) test kits for TB, …
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FDA clears Philips’ AI interventional cardiology assistance software
Philips has obtained US Food and Drug Administration (FDA) clearance for DeviceGuide, an artificial intelligence (AI)-based software designed to provide …
