Devices
FDA has approved a Boston Scientific PMA for the VICI Venous Stent System for treating iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies. The iliofemoral veins often
Devices
The New York Times editorial board is urging FDA to abolish the 510(k) medical device clearance process and fix other device regulatory loopholes amid growing reports of devices that were allowed on the market for decades without proper vetting. Just last month, FDA decided that surgical mesh products indicated
Devices
FDA has cleared a Treace Medical Concepts 510(k) to expand indications of the Lapiplasty 3D Bunion Correction System to treat pediatric patients 12 years of age and older. The device is designed to correct all three dimensions of the bunion deformity and permanently secure the root cause — an unstable
Devices
FDA has cleared a Lensar 510(k) for the Lensar Laser System with Streamline IV to expand the platform’s capabilities to include the creation of micro radial incisions that allow surgeons to treat additional corneal conditions post cataract surgery. The incisions are guided by the femtosecond laser platform’s
Devices
FDA is soliciting feedback on its Priority List of Patient Preference-Sensitive Areas that is intended to provide greater clarity to researchers and medical device industry members about areas in which CDRH would find patient preference studies most informative. An agency notice includes questions FDA would like answered about the
Devices
FDA has approved Medtronic’s CareLink SmartSync device manager that allows doctors to use an Apple iPad to program and manage data from the company’s BlueSync-enabled implanted cardiac devices. SmartSync is described as a next-generation programmer and pacing system analyzer that follows Medtronic’s popular CareLink 2090
Drugs
An updated Justice Department guidance document reinforces the importance of a robust, well-designed, and effective corporate compliance program in the department’s determination of whether to prosecute, impose monetary penalties, and require compliance obligations on a company accused of misconduct. Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in
Devices
While declining to order textured breast implants off the market, FDA says it is taking several steps to improve communication on the risks of breast implants and focus on evidence generation. A statement attributed to principal deputy commissioner Amy Abernethy and CDRH director Jeffrey Shuren says the agency is taking
Devices
The American Dental Association (ADA) is asking FDA to take legal action against SmileDirectClub (SDC) which, it says, is “placing the public at risk by knowingly evading the ‘prescription only’ restriction that FDA has placed on plastic teeth aligners and on dental impression material. For all intents and purposes, SDC
Devices
CDRH says it is reorganizing “to create an agile infrastructure that can adapt to future organizational, regulatory, and scientific needs.” An online post says implementation of the reorganization is taking a phased approach that started 3/18 and will be completed by 9/30. The post says that once fully
Devices
CDRH Office of Compliance materials engineer Scott McNamee says a final guidance on the use of animal tissues in the manufacture of medical devices succeeds a 1998 guidance that gave the FDA understanding of how to address the risk to the public health from bovine spongiform encephalopathy (BSE). “Since 1998,
Devices
FDA has cleared a Surgical Information Sciences 510(k) to market new visualization capabilities for its deep brain stimulation (DBS) software. Prior to this expanded clearance, the software was cleared for visualization of brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a DBS
Devices
Three K&L Gates attorneys say revisions to the AdvaMed Code of Ethics on medical device company interactions with healthcare professionals, scheduled to take effect 1/1/20, provide “helpful clarifications and additional detail about how best to structure arrangements between companies and healthcare professionals.” They recommend that companies
Devices
A 9/20-9/25/18 FDA inspection at Surgisil, Plano, TX, found that the firm is manufacturing the Perma Facial Implant without an approved PMA or IDE in effect. A 4/15 Warning Letter says the company has a cleared 510(k) for the device “intended for use in
Devices
FDA has cleared a VivaQuant 510(k) for its RX-1 wearable device, which is intended to continuously monitor a patient’s ECG and identify arrhythmias. Collected data from the wearable is communicated to the cloud using a built-in cellular connection, the company says. “Skilled staff in a U.
Devices
FDA has cleared a CoapTech 510(k) for the PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes. The device uses CoapTech’s point-of-care Ultrasound Magnet Aligned System platform to allow work in hollow body organs for novel diagnostic or interventional procedures, the company
Devices
Edwards Lifesciences has recalled its Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter due to difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. A recall notice says the company received reports of balloon fragmentation or detachment, which may cause damage
Devices
FDA has cleared a Biofourmis 510(k) for its RhythmAnalytics platform, a cloud-based software designed to automatically interpret cardiac arrhythmias. It uses an “enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which include ventricular arrhythmias, ventricular ectopic beats
Devices
FDA has approved a Xvivo Perfusion PMA for the Xvivo Perfusion System with Steen Solution Perfusate, indicated to temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that are thought to be unacceptable for transplant. “The device allows the transplant team to perform a more careful assessment of lung
Devices
FDA has issued a guidance, Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, to be used by members of industry who submit applications for orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) material. The document is intended to assist sponsors in determining the appropriate information and testing
Devices
FDA is reminding healthcare professionals and patients to carefully follow labeling and instructions for use for the Stryker Wingspan stent system and to consider the specific patient selection criteria for the device so they can appropriately determine whether the device is right for them. An agency safety communication says Wingspan
Devices
FDA has approved a Boston Scientific PMA for the LOTUS Edge Aortic Valve System. Delivered during a minimally-invasive procedure, the company says the transcatheter aortic valve replacement technology is indicated for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart