Archive for October 2018
Medical Rep Rebuked by FDA for Misleading Statements during Doctor’s Lunch
The latest admonishment from the FDA’s promo police is an unusual one. In it, the agency scolds an Eisai sales rep accused of misleading healthcare professionals during a presentation on antiseizure drug Fycompa. What’s different about the FDA’s latest untitled letter? It involves words spoken by a sales rep. It marks only the 14th time a warning…
Read MoreNovarad Lands FDA Clearance for its HoloLens-augmented Preoperative System
The possibilities of Microsoft’s HoloLens system have become a hot topic in the medical world in recent years. But last week Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company’s augmented reality headset. The newly FDA-cleared system uses the lens to project 2D, 3D and 4D interactive images onto a patient’s body…
Read MorePsychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA
In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant potential in early clinical evidence, allowing the FDA to assist and expedite subsequent development and review processes.…
Read MoreUK’s First Fetal Surgeries for Spina Bifida Successful
In a UK first, a team from University College London Hospitals (UCLH), University College London (UCL) and Great Ormond Street Hospital (GOSH) has successfully operated on the spinal cords of two babies with spina bifida still developing in the womb. The fetoscopic surgery was a success, with surgeons able to repair the defect in the spine…
Read MoreFirst US Clinical Trial using Focused Ultrasound for Alzheimer’s Disease Underway
Researchers at the West Virginia University (WVU) Rockefeller Neuroscience Institute have treated the first patient in a new, groundbreaking clinical trial utilizing focused ultrasound to open the blood-brain barrier (BBB) in patients with early Alzheimer’s disease. Led by neurosurgeon Ali Rezai, MD, the trial uses Insightec’s Exablate Neuro device to temporarily and reversibly open the BBB in regions of…
Read MoreApple and Zimmer Biomet team up to use Apple Watch to improve knee and hip surgery recovery process
As Apple pushes deeper into health care with the Apple Watch, the company is developing a plan to help people who are recovering from knee and hip replacement surgeries. On Monday, Apple announced a partnership with medical device company Zimmer Biomet, to combine a new app along with health-tracking data from the smartwatch to help determine why certain…
Read MoreMerit Medical to acquire Cianna Medical for up to $200M
Merit Medical said this week that it agreed to acquire Cianna Medical and its breast cancer localization and guidance devices for up to $200 million. Aliso Viejo, Calif.-based Cianna makes the Savi Scout wire-free breast tumor localization system, designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures. The device won 510(k)…
Read MoreCarestream digital x-ray system installed at remote Antarctic research station
A Carestream digital x-ray system has been installed at the Italian-French Concordia station in Antarctica, on a 10,500-foot mountain 620 miles from the coast. The station was first built to support the European Project for Ice Coring in Antarctica, but it became a permanent research station back in 2005. The system, a Carestream DRX-Transportable System/Lite,…
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