Devices
FDA has approved a Flowonix Medical PMA for the Prometra II Programmable Pump System for an expanded use with intrathecal baclofen. Flowonix began marketing the 40mL pump 11/2019, providing patients and clinicians a choice between 20 mL and 40 mL capacities when choosing an intrathecal pump delivery device. The
Devices
FDA has cleared a KinetiCor 510(k) for the KinetiCor Motion Correction System and its use with Siemens Magnetom Skyra 3T MRI scanner. KinetiCor is cleared as an accessory to the Skyra scanner, and it uses sensor-based technology to track patient movement during an MRI session. “It helps provide
Devices
FDA says the Teleflex Medical 12/13/19 recall of its Comfort Flo humidification system is Class 1. The recalled units were manufactured between 10/1/14 and 6/30/19 and were distributed between 10/1 and 10/31/19. Some 398,320 devices were recalled in the U.
Devices
Researchers from three universities say that FDA was late in removing mesh implants for pelvic organ prolapse repairs “despite the numerous safety warnings and adverse events reported from patients’ narratives.” Writing in Obstetrics and Gynecology, the researchers say that the factors that prevented timely response to an FDA warning first
Drugs
CDRH and CDER say they are collaborating on an effort to provide FDA’s view of the state of the current science in pharmacogenetics. They are launching a Web-based resource that includes a table describing “some of the gene-drug interactions for which the agency believes there is sufficient
Devices
ResMed has recalled its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure. According to a recall notice, the alarm may fail to work if the device has a failed electronic part or if it is stored without AC power connected for more than
Devices
FDA says an Abbott Vascular 1/29 recall of specific lots of its NC Trek RX coronary dilation catheter and NC Traveler RX coronary dilation catheters is Class 1. The catheters were distributed between 8/2019 and 1/2020 and 13,891 devices were recalled in the U.S. An
Drugs
The First Circuit Court of Appeals has sent back to a Massachusetts federal court a case in which purchasers of direct insulin glargine alleged that Sanofi artificially restricted competition in the market for insulin glargine by impermissibly extending its monopoly over such products. The appeals court reported that the purchasers
Devices
FDA has cleared an Additive Implants 510(k) for the SureMAX-X Cervical Spacer, a 3D-printed titanium spinal surgery device designed to create uniform end plate coverage and optimize load distribution. The device’s roughened porous and convex shaped surface provides contact with the bony endplates, the company says.
Devices
Philips Respironics has recalled (Class 1) its Trilogy EVO Ventilator and Trilogy EVO Universal Ventilator due to a software defect. The devices measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with appropriate accessories. According to a recall notice, the software defect can cause “inoperative
Drugs
FDA says that a January enforcement operation conducted with the government of India stopped some 500 shipments of illicit and potentially dangerous unapproved prescription drugs and combination medical devices from reaching American consumers. An FDA statement says Operation Broadsword, the first bilateral enforcement operation conducted with India, targeted packages entering
Drugs
Boehringer Ingelheim says the three case study examples in an FDA draft guidance on bridging for drug-device and biologic-device combination products are helpful in illustrating the stepwise approach described in the guidance. However, the company comment says that with the understanding that the three cases describe different scenarios,
Devices
CDRH has announced a 4/13-15 public workshop entitled “Towards Good Simulation Practices in Health Technologies” that will discuss modeling and simulation practices currently used in health technologies by the device industry. “The key topics to be discussed are the role of computational modeling and simulation in the regulatory
Devices
FDA has granted Bluegrass Vascular Technologies a de novo marketing order for its Surfacer Inside-Out Access Catheter System. The device is intended to obtain central venous access to allow catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude access
Devices
FDA has approved an Orthofix Medical PMA for the STIM onTrack mobile app version 2.1 for use with the company’s bone growth stimulators. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes, the company says. The new
Devices
FDA has classified as Class 1 a Tytek Medical recall of its PneumoDart, a compact, sterile, device that the agency says is “intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.” A recall notice
Devices
CDRH has released three new learning modules on the 510(k) third-party review program. The new modules are (1) Overview of the 510(k) Process: Guide for Third-Party Reviewers, (2) Deficiency Writing for Third-Party Reviewers, and (3) Deficiency Writing for Third-Party Reviewers: Examples. Available for each
Devices
FDA has announced a 3/9 workshop on “Detecting Circulating Tumor DNA for Cancer Screening.” The workshop will discuss the appropriate study designs needed to demonstrate the safety and effectiveness of cancer screening tests and to support cancer screening claims. It will also discuss the clinical, scientific, and regulatory challenges
Devices
FDA says the Medtronic recall of its MiniMed 600 Series insulin pumps, due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment, is Class 1. If the cartridge is not locked into place, under or over
Devices
FDA has published a guidance, Peripheral Vascular Atherectomy Devices—Premarket Notification 510(k) Submissions, with recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The document says its recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular submissions. Included in
Devices
FDA has cleared a Baxter International 510(k) for the Q-NRG+, a metabolic monitoring device that uses indirect calorimetry technology to accurately measure a patient’s calorie needs, or resting energy expenditure. The readings assist healthcare providers when prescribing nutrition therapy, which may include parenteral nutrition, the company says.
Devices
FDA has cleared a Rist Neurovascular 510(k) for the Rist Cath Radial Access Long Sheath and its use to introduce interventional devices into the peripheral, coronary, and neurovascular system. The company says it is the first device specifically designed for accessing the neurovasculature through the radial artery in the