ReCor Medical said its Paradise ultrasound renal denervation (uRDN) treatment showed consistent and significant blood pressure reductions in an analysis of pooled data from ReCor’s three Radiance randomized hypertension studies. “Pooling the data from the Radiance program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing […]
Otsuka Holdings
4 major cardiology trends you need to know from TCT 2022
Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive. The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations. Medtronic, Abbott, Edwards and Boston Scientific represent a few of the […]
ReCor Medical ultrasound renal denervation trial meets primary efficacy endpoint
ReCor Medical announced that a trial for its Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint. Palo Alto, California-based ReCor’s RADIANCE II pivotal trial evaluated Paradise as a treatment for hypertension. The trial operated under FDA investigational device exemption. ReCor presented results at TCT 2022 in Boston. They follow the company’s July […]
ReCor Medical, Otsuka say renal denervation system met primary endpoint in U.S. study
ReCor Medical and Otsuka Medical Devices today announced positive results from a trial of its renal denervation system for hypertension. The Radiance II U.S. FDA investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in […]
Pharma’s top 20 R&D spenders in 2020
The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. While the […]
Pandemic forces Proteus into bankruptcy
Proteus Digital Health has filed for Chapter 11 bankruptcy protection, noting that its efforts to raise money or sell the company fell victim to the COVID-19 pandemic. The Redwood City, Calif.-based company missed a $100 million funding target in December. Once valued at $1.5 billion, Proteus previously raised $420 million from investors including Novartis Venture […]
FDA clears Verily Study Watch for additional capabilities
Verily, Google’s life science’s sister company under Alphabet (NSDQ:GOOGL), has received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. The FDA announcement, last updated Jan. 20, did not include additional information. The agency cleared ECG capabilities on the Study Watch in January 2019. Launched in April 2017, the Study […]
Proteus pivots, hands digital mental health adherence business to Otsuka
Proteus Digital Health is abandoning its mental illness and cardiovascular work in its digital pill technology after its deal with Otsuka Pharmaceutical (TYO:4578) ended prematurely and will start to focus more on therapeutic areas, STAT News reports. Otsuka Pharmaceutical had been paying Proteus to develop a portfolio of digital medicines for serious mental health conditions. […]
Proteus Digital Health restructuring amid reported funding woes
Proteus Digital Health said today that it is restructuring, reportedly because it failed to close a $100 million funding round. A report by CNBC said the Redwood City, Calif.-based company missed the funding target. Once valued at $1.5 billion, the company previously raised $420 million from investors including Novartis Venture Fund and Kaiser Permanente Ventures, […]
Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US
Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into […]
The 10 most innovative medical devices of 2018
The nominees for the best medical technology of 2018 were recently announced for the 12th Annual Prix Galien USA Awards. The host of the awards, The Galien Foundation, awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Before the candidates can qualify […]