How Shockwave Medical plans to keep rivals at bay in burgeoning IVL sector
The intravascular lithotripsy (IVL) market is attracting some of the largest players in the medtech industry, though one of the …
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Subtle Medical lands FDA clearance for AI CT imaging software
Fresh off the back of closing a $33m financing round, Subtle Medical has received US Food and Drug Administration (FDA) …
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FDA clears KARL STORZ’s RUBINA Lens for use in open surgery
KARL STORZ has received clearance from the US Food and Drug Administration (FDA) for its RUBINA Lens exoscope, authorising its …
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Podcast: How Shockwave Medical plans to keep rivals at bay in burgeoning IVL sector
Shockwave Medical became the first entrant in the IVL space with the European launch of its IVL system for treating …
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Sibel Health’s ANNE One platform secures EU MDR CE mark
Sibel Health has received CE mark certification under the EU Medical Device Regulation (EU MDR 2017/745) for its ANNE One …
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NHS to offer precision prostate cancer treatment, cutting radiotherapy doses required
NHS England is set to offer thousands of men with prostate cancer a form of targeted radiation therapy for the …
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FDA grants IDE to SpinaFX for study of Triojection
SpinaFX Medical has received the US Food and Drug Administration (FDA) investigational device exemption (IDE) to study its Triojection therapy. The …
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GT Medical Technologies raises $100m for brain tumour therapy advance
GT Medical Technologies has raised $100m to advance its radiation therapy implant for treating brain tumours. The Arizona-based company’s oversubscribed Series …
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Gore secures CE Mark for venous stent to treat inferior vena cava
W L Gore & Associates Medical Products (Gore) has secured CE Mark approval under the EU's Medical Device Regulation (MDR) for …
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Novanta outlays $1.45bn for Riverpoint Medical buyout
Novanta has agreed to acquire Riverpoint Medical for an upfront price of $1.2bn to expand its portfolio into the minimally …
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FDA clears Xenix Medical’s Lux fusion system
Xenix Medical has obtained US Food and Drug Administration (FDA) clearance for its Lux expandable lumber interbody fusion system and …
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Stevanato unveils Deora pen injector for diabetes and weight management
Stevanato Group has introduced Deora, a multi-use, fixed-dose pen injector designed to support subcutaneous delivery of therapies for diabetes and …
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Medtronic secures CE mark for Stealth AXiS system for ENT surgery
Medtronic has received the CE mark for its Stealth AXiS surgical system, clearing the way for its use in ear, …
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Women’s health apps: governance and transparency key to success as opportunities bloom
As the use of digital health apps continues to surge across both the specialist health and general wellness spaces, so …
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FDA issues early alert for GE HealthCare’s infant resuscitation systems
The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ device issue with certain GE …
