Devices
FDA says it is aware from medical device reports of 414 cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) as of 9/30/17, including the death of nine patients. The new figure is in an agency online update on BIA-ALCL and agency recommendations for healthcare
Drugs
FDA says it is releasing a draft guidance to provide more complete and relevant information on the process for submitting postmarketing safety information on combination products. FDA commissioner Scott Gottlieb says the guidance “explains when a single, complete report can be used to meet multiple reporting requirements and what the
Devices
FDA has cleared a Restoration Robotics 510(k) to expand its Artas hair restoration technology to include robotic implantation. The company says the device is the first physician-assisted system to dissect, and assist in the harvesting of, follicular units directly from the scalp and create recipient implant sites using
Devices
Exactech has received 510(k) clearance to market Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. The liners are designed to work in conjunction with the Novation Crown Cup Acetabular System including InteGrip printed, 3-D porous material. The device features “advanced bearing material” for low wear
Devices
An 8/16-8/25/17 FDA inspection at Vilex in Tennessee, McMinnville, TN, found Quality System Regulation violations in the firm’s work as a specification developer and relabeler/repacker and conducting limited manufacturing operations for its Class 1 and 2 orthopedic implants and tools. A just-released 1/
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-LO Insert and Rotate Spacer System and its use in micro-invasive lumbar interbody fusion procedures. The device is available in PEEK material and is offered in 7-degree and 12-degree lordosis and multiple footprint options. It also
Devices
FDA has cleared a Cook Medical 510(k) for the Cellvizio Confocal Laser Endomicroscopy System and the Confocal Miniprobes. “Additional data provided in multiple peer-reviewed medical journals paved the way for this new clearance and indication for the Cellvizio system,” the company says. With the clearance, the device can
Drugs
FDA says it is delaying indefinitely the effective date of amendments to the existing medical product “intended use” regulations to give the agency more time to consider comments on the proposal. A Federal Register notice scheduled to be published 3/16 says the action does not delay the effective date
Devices
FDA has cleared a Royal Philips 510(k) for is ProxiDiagnost N90, a digital radiography-fluoroscopy system. The device provides “high-quality images with premium flat detector technology and the new dynamic Unique image processing,” that allows sequences to be stable and harmonized from the first frame to the end,
Devices
FDA has given 510(k) clearance to DxNow for its ZyMot ICSI and ZyMot Multi Sperm Separation devices. The devices are intended for preparing motile sperm from semen for use in treating infertile couples by intracytoplasmic sperm injection, intrauterine insemination, and in vitro fertilization procedures. They are intended to simulate
Devices
FDA says that Opternative, Inc., Chicago. IL, is marketing its On-Line Opternative Eye Examination Mobile Medical App device in the U.S. without FDA marketing clearance or approval. A just-released 10/30/17 Warning Letter says the product is considered a medical device because it is intended for
Devices
The 3rd Circuit Court of Appeals has followed views submitted by FDA in an amicus brief in a case involving allegations that the manufacturer of an artificial hip promoted the device illegally. A Washington Legal Foundation (WLF) online Legal Pulse says that on the question of whether the suit was
Devices
FDA has cleared an Exactech 510(k) for the Equinoxe Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe Shoulder System. The device is designed for anatomic total shoulder arthroplasty, and it features a single tray of instruments for operating room efficiency. It uses
Devices
The Securities and Exchange Commission has charged Silicon Valley-based Theranos, its founder and CEO Elizabeth Holmes, and former president Ramesh Balwani with raising more than $700 million from investors through an elaborate fraud in which they exaggerated or made false statements about the company’s blood test, business, and
Devices
FDA has cleared a CereMetrix 510(k) for its neuroimaging analytics and quantification platform CereMetrix Silver. The device allows healthcare providers to have access to objective neuroimaging that detects, quantifies and analyzes brain function down to the voxel level, according to the company. The image viewer is designed to analyze
Devices
Hyman, Phelps & McNamara says an FDA draft guidance on the concept and principles behind the “least burdensome” provisions is extremely important because the concept is a fundamental principle implicated by many FDA decisions that the agency still has not adequately implemented. “Repeated experience has shown that FDA has not
Devices
A 12/4-12/14/17 FDA inspection at Laser Dental Innovations, a San Jose, CA, manufacturer of dental handpiece and laser fiber optic surgical devices, found Quality System Regulation violations, according to a 2/27 Warning Letter. Specific violations cited were: * failing to establish procedures for implementing corrective and
Devices
An 8/28-8/31/17 FDA inspection at Dexcowin Co., Ltd., Seoul, Korea, found 13 violations of Quality System Regulations, according to a 2/20 Warning Letter. Specific violations cited were: * failing to establish and maintain adequate procedures for implementing corrective and preventive action; * failing to establish and maintain
Devices
FDA is alerting healthcare providers to the potential for increased “image artifact” or image voids associated with magnetic resonance angiography imaging for patient follow-up of certain post neurovascular embolization coil procedures. The coils are used in treating brain aneurysms and other vascular abnormalities. “As aneurysms treated with coils may
Devices
FDA has cleared a DeGen Medical 510(k) for the E3 MIS Modular Pedicle Screw System for thoraco-lumbar spine. The device is designed to address a wide range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods, according to the
Devices
FDA has approved a Medtronic PMA for its Guardian Connect continuous glucose monitoring (CGM) system for people with diabetes ages 14 to 75 years. The device is described by the company as the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose
Devices
A jury in Northern District of Indiana federal court has returned a $35 million verdict in favor of plaintiffs Barbara and Anton Kaiser for alleged injuries Barbara suffered from Ethicon’s Prolift transvaginal mesh. The nine jurors found that the company negligently designed the device and failed to adequately warn