Devices
Serious security flaws were found in Philips, GE, and Silex medical devices that, if exploited, could allow unauthorized access and let a hacker obtain elevated privileges, according to two HHS cybersecurity alerts. Healthcare IT News outlines the issues raised in the HHS reports and company actions to resolve them.
Devices
FDA has granted Immunicom a breakthrough device designation for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from patients’ bloodstreams and thus enables their natural immune system to more-effectively attack cancer tumors. “By removing immune system inhibitors from the blood without introducing
Drugs
FDA has released a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process. The proposal is intended to streamline and clarify the appeals process for manufacturers, and align the regulations with more recent legislative and regulatory measures. “These regulations address the process
Devices
Vyaire Medical has recalled its AirLife resuscitation devices and Broselow convenience kits due to risk of a malfunction caused by an error in the products’ design. The manual resuscitation devices are used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot
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A group of patient and industry organizations has written Congressional leaders urging them to enact legislation to “modernize the statutory oversight of clinical laboratory diagnostics, including laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).” The 5/9 letter noted that FDA is currently reviewing an amended discussion draft of
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FDA has cleared a Prisyna 510(k) for its Moisyn product designed to treat xerostomia (dry mouth). The condition occurs when there is a decrease in the presence of saliva. The glycomics-targeted therapy that has been shown in a clinical study to reduce pain and increase comfort, the company
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FDA says there are 10 confirmed cases of infection caused by bacteria within the Burkholder cepacia complex in three states: California (2), New Jersey (1), and Pennsylvania (7). An agency notice says the patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been
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FDA has cleared a C4 Imaging 510(k) for its second major brachytherapy product, the HDR MRI Marker. The positive-signal device is intended to be used prior to high-dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for
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Dräger Medical has recalled its Fabius Anesthesia Machines due to a potentially fatal production step error. The inhalation anesthesia machines are used in operating, induction and recovery rooms at hospitals and at magnetic resonance imaging settings with patients of all ages. The Class 1 recall was ordered due to excessive
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A new FDA letter to healthcare professionals provides recommendations about patient selection and the use of neurovascular stents used for stent-assisted coiling (SAC) of brain aneurysms. The agency says it has received reports associated with the use of these devices in treating unruptured brain aneurysms that “suggest some events
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Attorney Bradley Thompson (Epstein, Becker & Green) says he is hearing industry enthusiasm for FDA’s new software precertification program but not enough discussion about the program’s heavy cost to industry. “FDA wants more power. A lot more,” he writes. “And I for one am worried.” Thompson says the
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FDA has permitted the de novo marketing of Wilson-Cook Medical’s Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. It is applied during an endoscopic
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FDA has approved a CardioFocus PMA for the HeartLight Excalibur Balloon, a next-generation technology for treating paroxysmal atrial fibrillation. The device, which is intended to advance the company’s technology used in its FDA-approved HeartLight Endoscopic Ablation System, introduces “an advanced feature set that optimizes the speed and
Devices
Terumo has recalled its Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems due to revised cleaning instructions. The heater-cooler devices are used during surgeries to warm or cool patients as part of their care. Terumo took this action in response to FDA’s
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FDA has cleared a PeraHealth 510(k) for the PeraTrend, a predictive, real-time clinical surveillance technology. “PeraHealth solutions are powered by the Rothman Index (RI), a comprehensive measure of a patient’s condition for healthcare providers, leveraging data within a hospital’s existing electronic health record (EHR) to quantify
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CDRH is proposing a complete overhaul of its medical device review, safety surveillance and compliance structure to move to a more total product lifecycle (TPLC) approach to its decision making. Speaking at the Food and Drug Law Institute’s annual meeting in Washington, DC 5/3, CDRH director Jeff Shuren
Devices
FDA has issued a final order, General Hospital and Personal Use Devices: Reclassification of Sharps Needle Destruction Device, reclassifying the needle destruction device from Class 3 to Class 2 and renaming the device type to “sharps needle destruction device.” An agency notice says a sharps needle destruction device is an
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NPR and Side Effects Public Media say their investigation into Innovative Health Solutions’ Bridge medical device being used for opioid withdrawal found that FDA approved the device indication based on results from a clinical trial that was inaccurately described as a retrospective study. The report says the device had been
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FDA has approved a Medtronic PMA for its Deep Brain Stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures, in individuals 18 years of age or older who are refractory to three or more antiepileptic medications. “DBS therapy for epilepsy delivers controlled electrical pulses to
Drugs
The 7th Circuit Court of Appeals issued in March a powerful endorsement of the learned intermediary doctrine in multi-district litigation involving a Zimmer knee implant. Attorney Jonah Knobler (Patterson Belknap) writes in a Washington Legal Foundation Legal Opinion Letter that the court rejected arguments saying that the learned intermediary
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FDA has cleared a Conavi Medical 510(k) for its Novasight Hybrid System, which allows simultaneous imaging of coronary arteries with both intravascular ultrasound and optical coherence tomography. Such imaging is typically used by interventional cardiologists to image coronary anatomy during angioplasty and stenting procedures, the company says. The device
Drugs
In a Washington Legal Foundation webinar, attorneys John Boese and Douglas Baruch (Fried Frank) outlined the contents of two Justice Department internal memos dealing with False Claims Act cases and their impact on whistleblowers and federal prosecutors. Boese said that a 1/10 memo by Michael Granston states the department’