November 22, 2017

EMD Serono Wins FDA Nod for Redesigned Pen Injector

EMD Serono received the FDA’s approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector.

First approved in 2013, the device is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women.

The redesigned pen was evaluated in a simulated-use study involving 86 women with infertility and 30 fertility nurses.

Cianna Medical Gets FDA Clearance for Breast Tumor Localization System

The FDA cleared Cianna Medical’s non-radioactive breast tumor localization system for long-term implant.

Smaller than a grain of rice, the SAVI SCOUT implant allows physicians to pinpoint a location for a biopsy or a lumpectomy without time restrictions or interfering with magnetic resonance imaging studies.

FDA Clears Clinical Genomics-Quest Diagnostics Fecal Test

Clinical Genomics and Quest Diagnostics received FDA-clearance for InSure One, an at-home fecal immunochemical test (FIT).

The test uses a single sample of toilet bowl water to detect human hemoglobin in the user’s blood with the goal of detecting lower gastrointestinal bleeding, which may be associated with health conditions such as colorectal cancer and anemia.

Varian Medical Wins Shonin Approval for Cancer Treatment Device

Varian Medical Systems has obtained Shonin approval to introduce its cancer treatment device for commercial distribution in Japan.

The system enhances image-guided volumetric intensity modulated radiotherapy and shortens the time from installation to first treatment, the company said. The device uses a nine-step workflow process compared to the 30-step standard for other technologies.

Alcyone Lifesciences Scores FDA Clearance for Ventricular Catheter and Flusher System

Alcyone Lifesciences announced it has received FDA clearance for its Alivio ventricular catheter and flusher system for treating neurological condition called hydrocephalus, which can be life-threatening.

The Alivio System consists of a flusher and a ventricular catheter with a unique relief membrane. It is designed for non-invasive retrograde flushing the ventricular catheter with the goal of restoring or increasing cerebrospinal fluid.

FDA Clears Drug Coated Catheter for Marketing

The FDA has approved the Lutonix 035 drug coated balloon percutaneous transluminal angioplasty catheter, Model 9010 for commercial distribution with certain restrictions.

The device is a thin tube with an inflatable balloon at the tip used to treat narrowed or blocked blood vessels. It is used as an access site for dialysis in patients with chronic kidney failure.

The balloon is coated on its outer surface with the drug paclitaxel to help prevent the vessels from narrowing again.

FDA Clears First Device for Reduction of Opioid Withdrawal Symptoms

The FDA has cleared a new indication for Innovative Health Solutions’ electric nerve stimulation device for use in reducing opioid withdrawal symptoms as part of the agency’s continued efforts to address the U.S. opioid epidemic.

A chip contained in the NSS-2 Bridge device stimulates certain cranial nerves via electrical pulses to relieve acute physical withdrawal symptoms such as sweating, gastrointestinal upset, agitation, insomnia and joint pain.

The device can remain behind a patient’s ear for up to five days during the withdrawal phase.

Second Sight Receives EAP Designation for Visual Prosthesis System

Second Sight Medical Products received FDA expedited access pathway designation for the Orion Cortical visual prosthesis system.

The Orion is designed to transmit electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the perception of patterns of light.

By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore vision to blind patients.