Ablative Solutions announced today that it received positive results at six months from its post-market study for the Peregrine System infusion catheter, which accomplishes renal denervation by delivering microdoses of dehydrated alcohol. The results from the study of the safety and efficacy of the CE-Marked Peregrine System have been published in the Journal of the […]
Clinical Trials
Dyve Biosciences enrolls first patient in gout trial
Dyve Biosciences announced today that it enrolled its first patient in the Phase 2 clinical study of its DYV-700 topically administered therapeutic for acute gout treatment. Thousand Oaks, Calif.–based Dyve won FDA clearance to begin the Targets Phase 2 trial in December 2019. The double-blind, placebo-controlled, randomized clinical trial is set to evaluate the efficacy […]
Study: FDA should have banned pelvic mesh long before it did
Researchers who conducted a long-term study of women implanted with transvaginal mesh to treat pelvic organ prolapse (POP) concluded that the FDA should have banned the product sooner than it did. The study of 54,194 women in New York State revealed that women treated with mesh had an 8.8% risk of reintervention 5 years after […]
Medtronic to test new ways to fine-tune renal denervation
As it continues to seek a renaissance in renal denervation, Medtronic (NYSE:MDT) plans to study how to better fine-tune the technology to treat hypertension. The world’s largest medical device company, run out of Fridley, Minn., announced Feb. 4 that it has started enrollment in a pilot study that will use the company’s Symplicity Spyral renal denervation […]
Invo Bioscience to study extended use of fertility system
Invo Bioscience (OTCQB:IVOB) has received FDA approval to begin a clinical trial of its modified InvoCell system. The trial will measure InvoCell’s effectiveness in achieving fertilization, implantation, embryo development, clinical pregnancy and live birth after 5 days of continuous vaginal incubation, according to the Sarasota, Fla.-based company. The device is currently cleared for 3-day use. The […]
Laminate Medical completes enrollment in U.S. pivotal trial
Laminate Medical Technologies announced that it completed enrollment into its VasQ external support U.S. pivotal study of patients in need of an arteriovenous fistula (AVF) for hemodialysis. The study prospectively enrolled 144 male and female patients, both brachiocephalic and radiocephalic AVF patients, across 17 sites in the U.S. They are slated to be followed for […]
Nuvaira announces Griffin as new CFO
Obstructive lung disease treatment developer Nuvaira announced that Tom Griffin joined the company as its new chief financial officer. Griffin has a 30-year record of leadership roles that included guiding companies through investment financing, commercialization growth and IPO stages, according to a news release. He most recently served as CFO at Avedro, which completed its […]
FDA OKs new clinical trial for Abbott’s Amplatzer stroke prevention device
FDA has approved a clinical trial that will pit Abbott’s Amplatzer Amulet stroke prevention device against a newer class of blood thinners that are the present standard of treatment. Officials at Abbott (NYSE:ABT) think data from the new Catalyst trial could alter clinical practice, eliminating the need for some people with atrial fibrillation to take blood […]
Study: High- and low-dose drug-coated balloons equally effective in PAD
A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week. The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated ballon (DCB) […]
New 510(k) boosts iRhythm, Verily efforts for AFib screening
The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC) to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully […]
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 […]