Penumbra’s Thunderbolt approval poised to accelerate neuro thrombectomy innovation
Penumbra has secured FDA approval for its Thunderbolt system, the first device to offer computer-assisted vacuum therapy (CAVT) for stroke …
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FDA clears SurGenTec’s facet fixation system for degenerative disc disease treatment
SurGenTec has secured US Food and Drug Administration (FDA) clearance for ION-L, a lumbar facet fixation system for treating degenerative …
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FDA and MHRA forge new regulatory collaboration initiative
The US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will more formally …
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Raydiant concludes enrolment in pilot study at LSUHS
Raydiant Oximetry has completed enrolment and data collection for the initial 15 patients in its pilot study at Louisiana State …
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FDA approves Bayer’s Ambelvist contrast agent
The US Food and Drug Administration (FDA) has approved Bayer’s Ambelvist (gadoquatrane), a macrocyclic gadolinium-based contrast agent (mGBCA), for use …
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J&J outlays $1bn to strengthen Floridian contact lens manufacturing provision
Johnson and Johnson (J&J) has invested $1bn into strengthening its vision manufacturing capabilities in Florida, part of the company’s broader …
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FDA clears Dexcom’s Stelo as first OTC glucose monitor for children
The US Food and Drug Administration (FDA) has cleared Dexcom’s Stelo glucose biosensor system for children, making it the first …
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FDA oncology roundup: drugs, imaging agents and diagnostics gain approval
Over the last few days, the US Food and Drug Administration (FDA) has granted approval to several oncology products across …
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Dimora Medical introduces MegaSorb technology for advanced wound care
Dimora Medical has launched MegaSorb technology, designed for use in silicone foam dressings. The company announced the development as demand for …
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Fleming Initiative and Cepheid begin TRACE-CPE study on rapid CPE testing
The Fleming Initiative, a partnership between Imperial College London and Imperial College Healthcare National Health Service (NHS) Trust, and Cepheid, …
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FDA clears Penumbra’s Thunderbolt thrombectomy platform for stroke
Penumbra has secured US Food and Drug Administration (FDA) clearance for THUNDERBOLT, expanding the company’s computer-assisted vacuum thrombectomy (CAVT) lineup …
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Wave Neuroscience wins FDA clearance for precision PTSD therapy
The US Food and Drug Administration (FDA) has cleared Wave Neuroscience’s precision neuromodulation platform for post-traumatic stress disorder (PTSD) treatment, …
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FDA clears Alpha Tau to advance REGAIN trial enrolment
Alpha Tau Medical has received clearance from the US Food and Drug Administration (FDA) to proceed with enrolment of the …
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First patient treated in Airiver Medical’s RESTORE-2 trial for CRS
Airiver Medical has treated the first patient in its RESTORE-2 pivotal clinical trial assessing the ESSpand Sinus drug-coated balloon (DCB) …
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Industry calls for substantial reform to UK’s AI regulation in healthcare
The Medicines and Healthcare products Regulatory Agency’s (MHRA's) ‘policy-shaping’ consultation surrounding the regulation of artificial intelligence (AI) in healthcare has …
