The Latest
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FDA ends alternative reporting program, pledges to make MAUDE user friendly
The agency disclosed more than 6 million medical device adverse event reports were filed under the controversial system since 1997.
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Teleflex recalls 6M endotracheal tubes linked to two deaths
The devices, used to administer anesthesia and provide ventilation during surgical procedures, may become disconnected from the breathing circuit, resulting in insufficient oxygenation.
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Yale researchers predict 3D mammography to become standard of care
Use of digital breast tomosynthesis in breast cancer screenings jumped about 30% in the U.S. between 2015 and 2017, according to an analysis published Monday in JAMA Internal Medicine.
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Label should warn patients of paclitaxel device mortality signal, FDA panel says
The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.
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Hologic moves to acquire French ultrasound company
SuperSonic Imagine makes a cart-based device used for supplemental testing in women with dense breast tissue.
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NIH's Collins highlights progress on 3D printed human organs
Researchers at Rice University found a way to create an open-source bioprinting technology that grows soft hydrogel scaffolds one layer at a time.
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SEC ends Misonix foreign corruption probe without action
The maker of ultrasonic devices triggered the investigation in 2016 when it contacted the SEC with information about the business practices of its Chinese distributor.
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Glaukos strikes deal to buy retinal drug delivery company
The takeover will give Glaukos ownership of micro-invasive, sustained-released, bio-erodible drug delivery platforms.
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OIG finds Medicare overpaid $125M for radiation services
The inspector general wants CMS to implement billing requirements and other changes intended to prevent further unnecessary payments.
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FDA safety panel pans lack of paclitaxel device postmarket data on Day 1
The agency's Circulatory System Devices Panel Advisory Committee agreed Wednesday there is a mortality signal associated with paclitaxel-coated balloons and paclitaxel-eluting stents.
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Philips gets FDA approval for over-the-counter defibrillators
The devices were previously cleared for sale in the U.S. via the 510(k) pathway but now need PMA approval.
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Cardiology practice pays $2.5M to settle case involving genetic testing kickback allegations
In the latest case involving improper billing of Medicare for genetic tests, Nevada Heart & Vascular Center allegedly referred patients to Natural Molecular Testing and Iverson Genetic Diagnostics for payments.
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Swiss notified body to exit sector, heightening EU capacity fears
QS Zürich’s withdrawal will leave Switzerland with one medtech notified body, as new rules for the bloc near.
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Foam to stop abdominal bleeding gets FDA breakthrough nod
Gel-e's Life Foam product is designed to stabilize the patient in battlefield conditions or in a traumatic accident where life-threatening internal bleeding occurs and immediate urgent care isn't available.
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Bursting balloon catheters prompt Cook Medical recall
The action comes less than a year after the Bloomington, Indiana-based device maker resolved an FDA warning letter faulting its quality management system.
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As CMS decision on TAVR looms, a push for broader access
Proposed agency rules would lower the bar for hospitals performing the less invasive heart procedure, but would also raise the eligibility requirements to offer the treatment.
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Mount Sinai joins LabCorp to adopt Philips' digital pathology
The clinical lab giant will integrate the system into Mount Sinai’s eight hospitals, enabling remote review of images and surgical slides.
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FDA approves cochlear implant designed for MRI
The implant is designed for safe access to magnetic resonance imaging scans and doesn't require a head wrap or removal of the device's internal magnet.
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Bio-Techne gains breakthrough status for liquid biopsy prostate test
The test analyzes a patient's exosomes to help doctors determine whether a prostate biopsy is needed in patients with an ambiguous PSA test result.
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FDA safety panel to weigh paclitaxel-coated stents, balloons
The advisory panel, which will meet for two days starting Wednesday, will examine mortality and causality issues surrounding the paclitaxel-coated devices sold by BD, Medtronic, Cook Medical, Philips and Boston Scientific.
UPDATED: June 18, 2019 at 9:32 a.m. -
SaMD will increase device innovation: Fitch
FDA’s proposed regulatory framework will allow medical technology manufacturers to incorporate AI and machine learning while improving software monitoring.
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Health Canada seeks advice on device action plan next steps
The agency is asking for public comments on proposed rule changes that would require device makers to provide post-market safety information about products.
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Margin for error 'almost zero' in testing pediatric devices
As barriers dog pediatric device development, one FDA-backed group is trying a different path.
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FDA 'white hat' hacking tools may combat medical misinformation
Cybersecurity techniques the agency uses to protect medical devices could also help fight the spread of medical misinformation, former FDA Commissioner Robert Califf wrote in a journal.
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Lloyd's exits notified body services, leaving UK with 3
The withdrawal comes as Europe faces major concerns about capacity ahead of the new MDR and IVD regs.
