Devices
The Justice Department says that Exactech, a Gainesville, FL, medical device company, has agreed to pay $8 million to resolve allegations brought by four whistleblowers that the company violated the False Claims Act in connection with defective knee replacement devices. A department statement says the settlement relates to two separate
Devices
Becton Dickinson has expanded the Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing potential performance issues that could lead to serious injury or death in vulnerable patients. The recall, first initiated on 7/8 and expanded on 7/17, now covers
Devices
A 3/24-3/26 FDA inspection at SeniorLife Technologies in Bellevue, WA, determined that the firm is illegally marketing its SeniorLife.AI mobile application, intended to use artificial intelligence-based algorithms to screen and “pre-diagnose” mobility and cognitive health conditions. A just-released 8/21 Warning Letter says
Devices
FDA has issued an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters based on an earlier Medtronic recall due to issues identified with certain lots of cannula products where the catheter may not retain its shape. As of 7/
Devices
Dexcom is recalling (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error that leads to a missed “sensor failed” alert when the sensor’s transmitter encounters a hardware/firmware failure. Affected apps end the continuous glucose monitoring sensor session, stops reporting
Devices
Philips Respironics is recalling (Class 1) certain DreamStation auto continuous positive airway pressure (CPAP) and auto bilevel positive airway pressure (BiPAP) devices due to a programming error introduced during rework by a supplier, which may result in incorrect therapy modes (e.g., BiPAP configured as CPAP), limited pressure, unavailable features,
Devices
FDA has scheduled an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence (AI) in digital mental health medical devices, signaling heightened concern from the agency about the technology’s risks and regulatory gaps. AI-based mental health devices are increasingly being promoted as
Devices
FDA has cleared a new indication for neurocare group AG’s Apollo TMS (transcranial magnetic stimulation) therapy device to treat adolescents with major depressive disorder. A company statement says there are currently only two oral antidepressants approved for this age group, and both have Boxed Warnings for an increased risk
Devices
FDA has cleared a Microbot Medical 510(k) for its Liberty Endovascular Robotic System, a single-use, remotely operated device designed for peripheral endovascular procedures. The pivotal trial supporting clearance demonstrated 100% success in robotic navigation to the target with no device-related adverse events, as well as a 92%
Devices
Kimberly-Clark has agreed to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgical gowns, according to the U.S. Department of Justice. Federal prosecutors accused the Dallas-based company of introducing the defective gowns into interstate commerce with intent
Devices
Medtronic Perfusion Systems has recalled (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the devices may not retain their shape. According to a recall notice, FDA has determined the cause to be related to “process change control.” The single-use cardiovascular surgical catheter is
Devices
FDA has cleared a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbott’s Instinct continuous glucose monitoring (CGM) sensor for people with Type 1 diabetes. The Instinct device, designed exclusively for Medtronic’s automated insulin delivery systems, is the smallest and thinnest integrated CGM
Devices
FDA has approved an expanded use for Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system, allowing implantation of a new Evolut valve inside any previously implanted transcatheter aortic valve that has failed. The action broadens treatment options for patients with severe aortic stenosis or other valve failure who are
Devices
Ambu is recalling (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non-functional. “This defect can lead to an increased risk of harm caused by pressure changes (barotrauma) and delayed ventilation, since the ventilation pressure applied with Ambu SPUR
Devices
Hamilton Medical is recalling (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit. “The inner blue limb delivers fresh gas to
Devices
Integra LifeSciences is recalling (Class 1) its Extended Tip Applicators because the products may have high levels of harmful substances and may not have gone through a fully documented sterilization process. “Use of the affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a recall notice
Devices
FDA has issued an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed from where they are used or sold. The company stated that affected devices have a pump driver circuit assembly that does not meet current specifications. “These pump
Devices
A 1/27-1/30 FDA inspection at the Uscom Kft facility in Budapest, Hungary, determined that the company is illegally manufacturing and marketing several spirometers for which it does not have an approved PMA or IDE in effect. A just-released 7/30 Warning Letter also lists these Quality
Devices
A 3/4-4/16 FDA inspection at the LeMaitre Vascular facility in North Brunswick, NJ, found Quality System Regulation violations in the firm’s manufacturing of Artegraft Collagen Vascular Grafts. An 8/11 Warning Letter says the specific Quality System violations were: * failure to establish and maintain procedures to
Devices
A 3/31-4/23 FDA inspection at the Miach Orthopaedics facility in Westborough, MA, identified 11 Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of the Bridge-Enhanced ACL Restoration implant intended to treat anterior cruciate ligament injuries. An 8/19 Warning Letter says
Devices
FDA has granted Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, treatment-resistant systemic lupus erythematosus. This is the second time the device has earned the designation, following earlier recognition for treating sepsis. NucleoCapture is described as an extracorporeal apheresis column designed to
Devices
FDA has granted Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minimal residual disease (MRD) in patients with Stage II colorectal cancer after curative surgery. Quest says it introduced a laboratory-developed version of Haystack MRD in late 2024 and has