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BioWorld - Wednesday, February 11, 2026
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 17, 2019

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Australia proposes revising device essential principles to align with international practices

PERTH, Australia – The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal that to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU Medical Device Regulation (EU MDR). Read More

FDA advisory committee suggests disclosure of cybersecurity risks should be only to patients

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Stroke Medical raises $10.6M in series B to advance homegrown interventional devices

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Regulatory front

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Other news to note

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Appointments and advancements

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Product clinical data for Sept. 16, 2019

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Product regulatory actions for Sept. 16, 2019

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BioWorld MedTech's Cardiology Extra

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Gala Therapeutics gets breakthrough device designation for Rheox system

Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that. Read More

Cmr sets European private funding record for med-tech company with $240M series C

LONDON – Cmr Surgical Ltd. has again broken the record for a private financing round for a European med-tech company, raising £195 million (US$240 million) in a series C that will fund global commercialization of its portable robotic surgery system, Versius. Since the record-breaking series B in May 2018, when it raised $100 million, Cmr has set up offices in four continents and completed 30 first-in-human procedures. Currently, there are no commercial users, but the company now employs more than 400 people. Read More

Abionic touts positive data from sepsis trial

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