Chronic wound treatment device developer E-Qure said today it won FDA investigational device exemption approval to conduct a clinical trial of its novel Bio-Electrical Signal Therapy device. The New York-based company said its Bio-electrical Signal Therapy device is designed for non-invasively treating hard-to-heal chronic wounds, including pressure ulcers, diabetic foot ulcers, venous stasis ulcers and […]
Food & Drug Administration (FDA)
Sernova, CTI ink regulatory deal for Cell Pouch System
Sernova said it inked a regulatory deal with CTI Clinical Trial and Consulting Services to further the clinical development and IND application for its Cell Pouch drug delivery system. The London, Ontario-based company’s Cell Pouch is an implantable device that acts as an environment within the body to store therapeutic cells for patients with chronic diseases. Get […]
Report: St. Jude sold off older CRM devices after learning of battery issue
Updated: Corrected date of recall from 2015 to October 2016. St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report. The devices were recalled last month over issues with batteries failing with […]
More deaths tied to Medtronic’s SynchroMed II drug pump
The SynchroMed II implantable drug pump was linked to more than 100 adverse events including 2 previously unreported deaths, Medtronic (NYSE:MDT) said last month. In a letter to doctors published yesterday by the U.K.’s Medicines & Healthcare Products Regulatory Agency, Fridley, Minn.-based Medtronic said the SynchroMed II pump can delivery too much medicine but that the exact case of […]
FDA recommends new label for Bayer’s Essure
The FDA this week released new labeling requirements for Bayer’s (ETR:BAYN) controversial Essure and other permanent hysteroscopically-placed tubal sterilization implants. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities […]
FDA posts another Class I HeartWare HVAD recall
The FDA today posted a Class I recall notice for select Medtronic (NYSE:MDT) HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according […]
St. Jude wins FDA nod for Amplatzer PFO occluder
St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke. Approximately 25-30% of Americans have a PFO, according to the FDA, which typically causes no health problems and does not require treatment. While the cause of […]
FDA OKs stem cell, gene therapy trial for ALS
The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical […]
Senseonics submits FDA PMA application for Eversense CGM
Senseonics (NYSE:SENS) said today it submitted a premarket approval application to the FDA for its Eversense continuous glucose monitoring system. The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that […]
Corindus wins FDA nod for 2nd-gen CorPath GRX vascular robot-assisted surgery system
Corindus Vascular Robotics (OTC:CVRS) said yesterday that it won 510(k) clearance from the FDA for the CorPath GRX, it’s 2nd-generation vascular robot-assisted surgery platform, and plans to have it on the market during the 1st quarter of 2017. Waltham, Mass.-based Corindus said it added several features to the latest CorPath iteration, including the ability to control the guide catheter […]
NuVasive wins MR-safe indication from FDA for Magec spine system
NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA clearance for its Magec system, now indicated for safe use with 1.5 tesla magnetic resonance imaging devices. The San Diego, Calif.-based company’s Magec system is a magnetically controlled growth modulation system cleared by the FDA for pediatric spinal deformity, which the company claims is a 1-of-the-kind device […]