FDA issues warning to iRhythm over multiple violations
The US Food and Drug Administration (FDA) has issued a warning letter to iRhythm Technologies over regulatory violations pertaining to …
Google Cloud’s generative AI tool adopted by Mayo Clinic
Google Cloud is collaborating with Mayo Clinic to offer cutting-edge data retrieval for healthcare employees. Google Cloud’s Gen App Builder …
Cellf Bio’s first-in-human implantation of BioSphincter
Cellf Bio has reported the first human implantation of its autologous bioengineered sphincter BioSphincter in a Phase I clinical trial …
Cue Health gets FDA approval for Covid-19 at-home test
Cue Health has obtained de novo authorisation from the US Food and Drug Administration (FDA) for its Covid-19 at-home test, …
Increasing cataract surgical rates to drive growth of global artificial lens market
June is Cataract Awareness Month, a time aimed at raising awareness for the world’s leading cause of blindness. According to …
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Olympus introduces new ESG-410 electrosurgical generator
Medical technology company Olympus has introduced its new ESG-410 electrosurgical generator to treat enlarged prostate and bladder cancer. The electrosurgical generator …
Digital nutrition platform secures $15m cash injection
New York-based life science company Mend has received a $15 million series A investment from a consortium of venture firms …
Gore enrols first US patient in Vascular Stent trial
W L Gore and Associates (Gore) has enrolled the first US patient in its study for the assessment of its …
GIE Medical secures BDD from FDA for multi-stage DCB
GIE Medical has secured breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its ProTractX3 TTS …
Precision Neuroscience reports first human use in neural interface trial
Precision Neuroscience has successfully concluded the first-in-human procedures in a pilot clinical study of its neural implant system called Layer …
Teleflex receives FDA approval for MR Conditional labelling of EZ-IO Needle
Teleflex has received 510(k) clearance from the US Food and Drug Administration (FDA) for the MR Conditional labelling of the …
Biocomposites strengthens its portfolio with acquisition of Artoss
UK-based medical device company Biocomposites has acquired German firm Artoss, adding the company’s NanoBone range to its portfolio. Artoss is a specialist …
Happy scrolling – Apple launches mental health tracker
Whilst much of the talk from Apple’s biggest product event in years was centered around its augmented reality headset, an …
IDE clinical trial for artificial cervical disc completes enrollment
Synergy Spine Solutions has enrolled the last patient in its investigational device exemption (IDE) clinical trial. The 1-Level Synergy Disc …
Sensydia receives funding for AI-driven cardiac assessment platform
Cardiac diagnostic company Sensydia has received a $3m grant to accelerate the development of its artificial intelligence (AI)-driven cardiac assessment …