Cala Health announced today that it received FDA breakthrough device designation for its Cala Trio treatment for action tremors in people with Parkinson’s disease. Burlingame, Calif.-based Cala Health’s Cala Trio is FDA cleared to relieve hand tremors from essential tremor (ET), but the company is now nearing the initiation of clinical trials to evaluate the […]
Cala Health
Cala Health touts results of real-world tremor study
Cala Health today touted data demonstrating that its Cala Trio therapy is safe and effective in improving essential tremor in patients. Burlingame, Calif.-based Cala Health said in a news release that the data for the wearable technology came from use at home, unsupervised and under real-world conditions, further validating the results reported in the Prospect […]
MedTech 100 roundup: Stocks were practically unchanged last week
Despite plenty of ups and downs coming in the stock market for the medtech industry, there was hardly any movement from week to week. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.6 points at the end of last week (Aug. 21). Overall, medtech stocks saw […]
DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?
In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer. We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is […]
Cala cites positive data in Trio tremor trial
Bioelectronic company Cala Health released positive data from its ongoing PROSPECT trial demonstrating that a majority of patients using its FDA-cleared Cala Trio device reported a reduction in hand tremors. The study — published in Tremor and Other Hyperkinetic Movements — enrolled 263 patients with essential tremor across 26 sites. Patients wore the Trio on […]
CEO Ryan explains how Cala Health is building bioelectronic medicine business
In this week’s episode of DeviceTalks Weekly, Tom Salemi, editorial director of DeviceTalks events and content, visits with Renee Ryan, the CEO of neuromodulation startup Cala Health. Ryan came to Cala from the venerable medtech investor Johnson & Johnson Development Corp., where she made over 15 investments helping to create companies including Auris Surgical, Cala […]
Cala Health touts top-line data on Trio wearable for essential tremor
Cala Health yesterday presented top-line data from a study of its Cala Trio therapy for treating essential tremor. Trio is a wrist-worn neuromodulation device designed to stimulate nerves responsible for the tremor to provide symptomatic relief. Burlingame, Calif.-based Cala Health said its Prospect trial, which is touts as the largest ever conducted for essential tremor, […]
Innoblative taps ex-Lumicell chief Londy for CEO | Personnel Moves, Sept. 13, 2019
Innoblative Designs last week named former Lumicell chief executive Kelly Londy as its new CEO. Apart from her two-year stint at the Lumicell helm, Londy was COO at Accuray (NSDQ:ARAY) and worked at GE Healthcare and Philips Healthcare. “Innoblative’s Sira RF ablation device offers unique capabilities that address shortcomings in the current advanced energy surgical market,” […]
Cala Health licenses MGH-developed neuromod tech
Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases. The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a […]
Cala Health launches trial for Cala Two neurostim device for essential tremor
Cala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device. The Burlingame, Calif.-based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor. The 500-patient, single-arm […]
