Devices
FDA has granted Biolinq a de novo authorization for its Shine system, the first fully autonomous, needle-free glucose sensor in the U.S, according to the company. The device features an integrated display and does not require a smartphone to deliver glucose readings. Unlike traditional continuous glucose monitors that
Devices
FDA has published a guidance, Computer Software Assurance for Production and Quality System Software, with recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The document says it describes: * computer software assurance as a risk-based
Devices
Olympus has recalled (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured prior to 5/12 after receiving reports of device components detaching during procedures. The ViziShot 2 FLEX is protected by a hypotube and sheath, a recall notice says, adding that the “hypotube protects the sheath from
Devices
FDA has issued an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automated Impella Controllers be removed from where they are used or sold. “Abiomed identified Automated Impella Controller purge pressure issues due to purge retainer failures, such as cracks,” the alert
Devices
FDA has released a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests during a declared public health emergency. The guidance, Consideration of Enforcement Policies for In Vitro Diagnostic (IVD) Tests During a Section 564 Declared Emergency, explains the factors FDA will
Devices
FDA has approved Medtronic’s Altaviva implantable tibial neuromodulation device, described by the company as a minimally invasive therapy for treating urge urinary incontinence. The device, inserted near the ankle, works by sending mild electrical impulses to the tibial nerve to help restore communication between the bladder and brain, according
Devices
FDA appears to be escalating medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in on compliance gaps, according to a new analysis from law firm Hogan Lovells. As of early September, the agency had issued 19 Warning Letters citing Quality System Regulation
Devices
FDA has issued a final rule rolling back a 2024 regulation that expanded the agency’s authority over laboratory-developed tests (LDTs), following a federal court decision that struck down the earlier policy. The move restores the regulatory definition of “in vitro diagnostic products” to its pre-2024 language, removing
Devices
FDA is issuing an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing the TactiFlex Ablation Catheter from its packaging. “Abbott has become aware of tip detachment events during catheter removal from the packaging,” the alert says. “Improper removal from the packaging can
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