Medtech contract research organization Factory-CRO Group is changing its name to Avania. Formed Boston-based Boston Biomedical Associates (Marlborough, Mass.), Factory CRO (Bilthoven, Netherlands), Five Corners (Artarmon, Australia), and MileStone Research Organization (San Diego), Avania said it will bring together regional teams of experts across a wide range of therapeutic specialties, including medical devices, novel technology, […]
COVID-19 investigational vaccine clinical trial underway
A Phase 1 clinical trial for an investigational COVID-19 vaccine is underway at Kaiser Permanente Washington Health Research Institute in Seattle. The open-label trial plans to enroll 45 healthy adults aged 18 to 55 years over a six week period. The first study participant received the vaccine yesterday. Researchers at Kaiser Permanente Washington Health Research […]
Johnson & Johnson: Clinical study of potential coronavirus vaccine could start by end of year
Johnson & Johnson (NYSE:JNJ) said today that its Janssen Pharmaceutical Cos. has forged a partnership with the Beth Israel Deaconess Medical Center (BIDMC) to support coronavirus vaccine development. Janssen and the virology lab led by Dr. Dan Barouch at BIDMC have started preclinical testing of multiple vaccine prospects, with the goal of identifying a COVID-19 […]
Viveve Medical completes enrollment for study of its stress urinary incontinence treatment
Viveve Medical (NSDQ:VIVE) announced that it completed enrollment in a short-term feasibility study for its cryogen-cooled monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI) in women. The international, three-arm study is a prospective, randomized, single-blind clinical trial comparing Viveve’s CMRF treatment and a cryogen-only sham to an inert sham treatment in women with SU. Englewood, […]
Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics entered into a clinical trial research agreement with the University of Pennsylvania to observe its EsoCheck esophageal cell collection device. EsoCheck with “collect & protect technology” is designed to offer a less invasive, more efficient and cost-effective alternative to endoscopic biopsies when managing patients with eosinophilic […]
LivaNova adds Verily to depression study
LivaNova (NSDQ:LIVN) announced that it has added Google’s (NSDQ:GOOGL) Verily to its study of vagus nerve stimulation (VNS) therapy for difficult-to-treat depression (DTD). The Recover clinical will gather quantitative data on patient behavior using Verily’s technology and analytics. The data could help the researchers understand depressive episodes and the patient’s response to treatment. Study participants will […]
PhysIQ touts VA study showing AI predicting hospitalizations
PhysIQ today is touting results from a study testing the ability to detect heart failure exacerbation using wearable sensors and personalized analytics based on artificial intelligence. The Link-HF study set out to assess the ability to predict rehospitalization due to heart failure exacerbation using analytics applied to continuous wearable sensor data, according to a news […]
Abilitech aims to arm people with independence
Some have dubbed Abilitech’s device “a wheelchair for the arms.” Its machined aluminum exoskeletal arm and breathable cloth vest use a spring counterbalance system and a “living hinge” that spreads the load, making it — and the arm — feel weightless. Nancy Crotti, Managing Editor Rob Wudlick brushed his teeth on his own recently for […]
Aria completes $31m Series B for its pulmonary hypertension treatment device
Pulmonary arterial hypertension (PAH) treatment developer Aria CV announced today that it completed a $31 million Series B financing round. The proceeds from the round, led by private equity and venture investor Xeraya Capital, are earmarked for funding St. Paul, Minn.–based Aria CV’s first U.S. clinical study. Aria CV’s early feasibility investigational study is set […]
Abbott touts real-world data around FreeStyle Libre system
Abbott (NYSE:ABT) recently announced that new real-world data shows that users of its FreeStyle Libre continuous glucose monitor (CGM) have improved on four different fronts. Users of the Abbott Park, Ill.–based company’s device showed better glucose control, increased time in target glucose range, decreased time in hyperglycemia and hypoglycemia and reduced HbA1C (average glucose levels over […]
Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech
Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system. FDA also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication. Cardiovalve touted that it is the first privately held company to have the FDA early feasability study […]
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