Diagnostics & Healthcare News

Boston Scientific said yesterday that it’s planning a three-year restructuring program that’s slated to cost at least $200 million. The Marlborough, Mass.-based medical device maker said it expects to maintain roughly the same number of workers, although there will be some churn as new jobs are created. “[T]he company does expect some employee attrition and…

Senseonics Holdings, Inc., a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has received FDA approval for qualified health care providers to be trained and certified to provide patients with the…

Concepta plc, the innovative UK healthcare company and developer of the proprietary self-test platform (“myLotus”) and suite of emerging test products targeting the mobile health market is pleased to announce it has received CE-Mark certification for its myLotus branded products for women’s fertility. Given the stringent regulatory environment for diagnostics, CE certification is a major milestone…

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…

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.…

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…

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…

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)…

A former plastic surgeon at Orlando Health has filed a $100 million defamation lawsuit against the health system, alleging that the hospital fired him without cause and made false statements about him, portraying him as “mentally and emotionally unstable.” In the lawsuit, filed last month in Orange County, Dr. Jeffrey Feiner, a reconstructive plastic surgeon, alleges that the…

Aflac’s robotic therapy ducks have started waddling their way to children’s cancer hospitals nationwide after making their debut at CES earlier this year. The company is distributing the robotic waterfowl through a series of events as part of its activities for National Childhood Cancer Awareness Month. It started with the Aflac Cancer and Blood Disorders Center of Children’s…