Devices
FDA has updated a 10/2015 safety communication calling attention to infections associated with heater-cooler devices and steps that healthcare providers and facilities can take to mitigate patient risk. Over the past few months, the agency says it has continued to evaluate contamination and infection-related issues associated with
Devices
TransEnterix says FDA has extended its review of a 510(k) for the SurgiBot System, a robotic surgery device for use in laparoscopic procedures. The system allows multiple instruments to be introduced and deployed through a single incision. The device’s flexible instruments may be controlled directly by the surgeon
Devices
Rep. Mike Fitzpatrick (R-PA) is asking members of congressional appropriations subcommittees to exclude the Bayer Essure permanent sterilization device from federal procurement. He says that the government has spent millions of dollars on the device in the past few years. Letters were sent to the subcommittees on military construction,
Drugs
FDA is seeking comment by 5/3 on its February draft guidance on human factor studies and related clinical study considerations in combination product design and development. Writing in an FDA Voice blog post, associate commissioner for special medical programs Jill Warner and Office of Combination Products director Thinh Nguyen
Devices
FDA has approved an Intersect ENT PMA supplement a for an expanded indication for its Propel mini steroid releasing sinus implant to treat patients undergoing frontal sinus surgery. The approval allows the company to market the device for implanting in the frontal sinuses, located behind the eyebrows. Previously, it was
Devices
FDA has cleared an Opsens 510(k) for the OptoWire II, an optical guidewire developed to measure fractional flow reserve to diagnose severity of coronary stenosis for guiding the treatment of patients with coronary artery disease. The next-generation device features a new design comprising a hydrophilic coating that the
Devices
FDA has cleared an ACell, Inc. 510(k) for its MicroMatrix device and its concurrent use with Cytal Wound Matrix or Cytal Burn Matrix devices. The micronized particulate form of ACell’s patented Urinary Bladder Matrix technology provides coverage of the wound bed, especially in irregular wounds. It provides a
Devices
FDA has cleared a Great Basin Scientific 510(k) for its Shiga Toxin Direct Test, a stand-alone molecular diagnostic for detecting Shiga toxin-producing E. coli (STEC) and the serotype O157 directly from a patient specimen. The test can be run on the Great Basin Analyzer, which also performs
Devices
FDA has cleared a Stimwave 510(k) for its StimQ Peripheral Nerve Stimulator (PNS) System for relieving severe intractable chronic pain of peripheral origin. The implant is placed next to peripheral nerve locations where pain is originating, according to the company. It wirelessly delivers small pulses of energy to electrodes
Devices
A 10/19-10/23/15 FDA inspection at the Terumo Medical Corp. facility in Elkton, MD, found Quality System Regulation violations in the firm’s manufacturing of destination guiding sheaths for renal, carotid, and peripheral use. A 3/17 Warning Letter from the agency’s Baltimore District Office says
Devices
CDRH has posted a final guidance on “Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.” The document provides an assessment paradigm for multi- and single-component device types with various dimensions and shapes. “Multi-component passive devices, such as orthopedic fixation
Drugs
The Federal Trade Commission (FTC) is signaling an interest in the integrity of data cited by companies to support marketing claims. Attorneys Raqiyyah Pippins and Neha Patel (Arnold & Porter) write in an online post that in a letter defending its finalized consent order with Carrot Neurotechnology, FDA said that
Devices
FDA has proposed a ban on powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. An agency notice says that while their use is declining, they still “pose an unreasonable and substantial risk of illness or injury to health care providers, patients
Devices
Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS) have introduced legislation (S.2737) to improve the effectiveness of medical device operations at FDA. They say the bill, which has been referred to the Senate HELP Committee, would: Provide greater predictability and transparency to FDA’s process for recognizing
Devices
FDA has approved Roche’s hepatitis C virus (HCV) quantitative RNA test to be used as an aid in diagnosing HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used to confirm an active hepatitis infection, in addition to
Devices
FDA has cleared a Vermillion 510(k) for its Overa OVA1 test for determining ovarian cancer risk in conjunction with independent clinical and imaging assessment prior to planned surgery for a women with a pelvic mass. The second generation OVA1 test replaces two of the five OVA1 biomarkers in the
Devices
FDA has cleared an Olea Medical 510(k) for its Olea Sphere 3.0 medical imaging software package, which is intended for picture archiving, post-processing and communication. The software is designed to help standardize both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with magnetic resonance
Devices
Verathon has begun a Class 1 recall of its GlideScope Titanium Single-Use Video Laryngoscope due to potential video feed disruptions. The device is used to obtain a clear view of the vocal cords and to assist in inserting a tracheal tube used during other medical procedures (general anesthesia). A
Devices
FDA’s Circulatory System Devices Panel has voted unanimously to not recommend approval of an AngelMed PMA for its Guardian System to warn about electrocardiogram elevation changes in the segment between the S wave and the T wave, which potentially is linked to coronary ischemia. Panel members cited protocol deviations
Devices
FDA has cleared a CardiacAssist 510(k) for its TandemLung oxygenator, a device that acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood. It uses a radial flow design coupled with advanced polymethylpentene fibers to transfer oxygen into the blood for patients requiring cardiac
Devices
FDA has classified as Class 1 a recall by Arrow International of its intra-aortic balloon catheter kits and percutaneous insertion kits due to a sheath separation issue. If the separation occurs, the patient may bleed from the sheath. Interruption or loss of intra-aortic balloon pump treatment may also
Devices
FDA has cleared a PneumaCare 510(k) for its Thora-3DI imaging device, intended for use in measuring breathing. The device uses structured light plethysmography to measure breathing by detecting movement in the chest and abdomen. It can be used to measure respiratory status in patients with a range of