Overview of development in the transcatheter tricuspid valve replacement market
Edwards Lifesciences’ monopolisation of the TTVR market has not dissuaded other companies from trying to enter the market. Credit: MAD.vertise via Shutterstock. Open surgery has been the primary treatment for severe tricuspid valve disease such as tricuspid regurgitation (TR). Simultaneously, these patients are typically not good candidates for receiving surgical treatment – patients exhibiting severe […]
FDA warns of fraudulent data coming from third party labs
Whilst no one laboratory or submission to the FDA is cited, the body noted that many of the submissions containing fraudulent data contain data provided by third-party test labs based out of China or India. Credit: Shutterstock / Jeppe Gustafsson The US Food and Drug Administration (FDA) is warning medical device manufacturers and sponsors to […]
MMI secures $110m Series C funding for Symani Surgical System
The system enables surgeons to mimic human hand movements at a microscale. Credit: MAD.vertise / Shutterstock.com. Medical Microinstruments (MMI) has secured $110m in a Series C financing round, led by Fidelity Management & Research Company, to support the commercialisation of its Symani Surgical System. The investment is expected to support the expansion of clinical evidence […]
Aethlon Medical signs MTA for Santersus devices
The filtration system is designed to capture and eliminate harmful exosomes and life-threatening viruses from blood and other biological fluids. Credit: Kateryna Kon/ shutterstock.com. Aethlon Medical has signed a materials transfer agreement (MTA) for Santersus’ NucleoCapture and HemoNucleoCapture devices. Under the MTA terms, Santersus will supply its devices, which are designed to eliminate neutrophil extracellular […]
Do not use smartwatches to measure glucose levels, FDA says
Watches or rings that claim to directly measure blood glucose levels via non-invasive tech are illegally marketed. Image credit: Shutterstock/Eviart. No, smartwatches cannot directly measure glucose levels. The US Food and Drug Administration (FDA) says to avoid devices that claim to do this, warning of the possible health risks. Despite an ample supply of smartwatches […]
ARC lays out clinical plan for surgical adhesion prevention liquid
Both JOCOAT and IPCOAT have the same polymer in them, with the JOCOAT being a more concentrated 10 mL device for use in orthopaedic surgeries, whilst IPCOAT is a less concentrated device for gynaecological and abdominal surgeries. Image Credit: bluedog studio / Shutterstock. Canada-based ARC Medical plans to evaluate its fluid medical devices, JOCOAT and […]
Pelvital’s Flyte device proves effective in published urinary continence study
SUI is a condition characterised by urine leakage when the bladder is under pressure such as when exercising or sneezing. Credit: aslysun via Shutterstock. Women’s health technology company Pelvital has published a study (NCT02954042) demonstrating the efficacy of its Flyte device to treat women with stress urinary incontinence (SUI) and weakened pelvic floor muscles. Published […]
Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study
Researchers concluded that telehealth abortion enables equitable access to healthcare. Credit: Carl DMaster / Shutterstock A large study about telehealth abortion conducted in the US has concluded that it is “effective, safe and comparable to published rates of in-person medication abortion care.” The results, published in Nature, come at a significant point in the debate […]
Aptar acquires digital health company Healint
Healint’s Migraine Buddy tracking app boasts over three million registered users. Credit: Aptar Digital Health/Businesswire. Aptar Digital Health has announced the acquisition of Healint, a Singapore-based company known for its virtual clinical studies and patient support applications. The acquisition forms part of Aptar Digital Health’s efforts to expand its portfolio in the neurology sector and […]
BD, Camtech Health partner for at-home HPV testing in Singapore
The BD’s assay is said to be the only US FDA-approved test that identifies an extended set of HPV types. Credit: PRNewswire/ BD (Becton, Dickinson and Company). Becton, Dickinson and Company (BD) has partnered with Camtech Health to enhance access to cervical cancer screening in Singapore by introducing a self-collection human papillomavirus (HPV) test for […]