Capstan Medical secures $110m for robotic-assisted heart valve implants
Capstan Medical has raised $110m to advance its robotic platform for cardiac disease treatment in one of the larger medtech…
13 Dec 2024
Roche’s cobas 6800/8800 systems receive CE certification
Roche has received the CE mark certification for its newly updated cobas 6800/8800 systems 2.0, improving laboratories and testing capabilities. The upgrade of the systems is set to optimise laboratory…
13 Dec 2024
FDA grants PMA approval to J&J MedTech’s heart pumps for paediatric use
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Johnson & Johnson (J&J) MedTech’s Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, allowing…
13 Dec 2024
Natera begins subject enrolment in colon cancer detection test trial
Natera has begun the subject enrolment in the randomised Phase III SAGITTARIUS clinical trial designed to assess the Signatera test in determining personalised adjuvant treatment strategies for individuals with stage…
12 Dec 2024
FemPulse wins FDA IDE to use overactive bladder vaginal ring in pivotal trial
FemPulse is set to enter the pivotal clinical trial phase with its neuromodulation system to treat overactive bladder after the US Food and Drug Administration (FDA) awarded the company an…
12 Dec 2024
FDA issues alert on potential high-risk issue with Fresenius infusion pump
The US Food and Drug Administration (FDA) has issued an early alert over a potential high-risk issue with Fresenius Kabi’s infusion pumps. The Ivenix large-volume pump (LVP) is designed to…
12 Dec 2024
Osteotec to distribute Cerapedics’ bone graft products in UK and Ireland
Osteotec has signed an exclusive agreement for the distribution of Cerapedics' i-FACTOR bone graft portfolio in Ireland and the UK. The agreement is aligned with Osteotec's mission to improve surgical…