Tag:
medical device clinical trial
Latest Headlines
Latest Headlines
St. Jude starts clinical trial of full-body MRI-friendly pacemaker
St. Jude Medical ( $STJ ) has had a difficult couple of weeks, battling Dr. Robert Hauser over a study questioning the safety of its Riata defibrillator leads, particularly when compared with Medtronic's ( $MDT ) Quattro Secure offering. But things have been looking a bit up this week.
Brainsway surges on results of depression study
Brainsway surged on the Tel-Aviv Stock Exchange today after the company announced positive results from a study of its transcranial magnetic stimulation (TMS) treatment in severely depressed patients.
FDA looks to improve the representation of women in device studies
The FDA has issued a draft guidance to address the underenrollment of women in medical device clinical trials. The agency says the objectives of the guidance are to better communicate the balance of
FDA OKs Medtronic's study of second-generation pacing system
The FDA has approved Medtronic's ( $MDT ) IDE application and pivotal clinical trial protocol to begin evaluating the Advisa DR MRI SureScan pacing system. The randomized Advisa MRI study will seek to
Nordion to evaluate TheraSphere in PhIII
Nordion has received FDA approval to conduct a Phase III clinical trial to evaluate TheraSphere under an investigational device exemption as a treatment for colorectal cancer patients whose disease
Oval Medical raises cash, reports positive study results
Oval Medical Technologies, a medical device start-up based in the U.K., has raised another stack of cash and announced positive results for a trial that compares its novel autoinjector with two
Abiomed ($ABMD) ends PROTECT II study
Abiomed ($ABMD) has ended its PROTECT II study of its Impella cardiac assist device based on a recommendation of a data safety monitoring board. The company's shares dipped 14 percent at $10.50 after
EnteroMedics gets conditional OK for obesity study
EnteroMedics (NASDAQ: ETRM) has received conditional approval from the FDA for its IDE application outlining plans for studying the safety and efficacy of its obesity treatment. The announcement sent
AtriCure cleared to try hybrid atrial fibrillation procedure
AtriCure, the maker of cardiac surgical ablation systems, has received a conditional nod from the FDA to evaluate the safety and efficacy of a hybrid procedure to treat patients with persistent forms
Study: Medtronic brain stimulation device holds promise
Deep brain stimulation helped to reduce the frequency of a type of seizure in patients who hadn't responded to other treatments, according to data from a study published in the journal Epilepsia. The
