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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 …
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 …
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 …
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 …
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 …

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 …
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 …
‘Major milestone’ for UK clinical trials as new framework laid in parliament

New legislation is being laid in the UK Parliament today (12 December) that will change the regulatory framework for clinical …
RevBio secures green light from FDA to expand bone adhesive clinical trial

US-based bone adhesive company RevBio has received approval from the US Food and Drug Administration (FDA) to expand an ongoing …
Eye health company Bausch + Lomb’s affiliate acquires Elios Vision

Bausch + Lomb has announced the acquisition of Elios Vision by an affiliate to improve the company's capabilities in treating …
SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes

SamanTree Medical has revealed that its Histolog scanner, a confocal laser microscope, significantly decreased breast-conserving surgery (BCS) reoperation rates by …
Protaryx Medical completes first-in-human trial of transseptal puncture device

US-based Protaryx Medical has completed a first-in-human trial of its transseptal puncture (TSP) device. The company’s trial enrolled five patients, with …
Gender-affirming care in US under threat from new Trump policies

President-elect Donald Trump campaigned in 2024 on a chaotic platform that included promises to roll back access to gender-affirming care …
EndoQuest wins FDA IDE to commence robot trial in colorectal indication

EndoQuest Robotics has won an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing the company …
MeMed’s sepsis test receives FDA breakthrough device status

MeMed has received breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its MeMed Severity test, …