FDA: Page 80
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Sens. Warren, Murray probe FDA's 'alarming' progressive device approval idea
The Democrats gave the agency until July 8 to respond to their questions on a recent budget proposal that seeks to grant FDA a two-step approval process for medical devices for life-threatening conditions.
By David Lim • July 8, 2019 -
Spanish agency steps up to become an MDR notified body
The decision comes as some in the sector have expressed concerns about whether there will be enough notified bodies to adequately support the transition to the EU's new medical device rules.
By Susan Kelly • July 8, 2019 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
CMS extends ambulatory blood pressure monitoring coverage
In a change, patients with masked hypertension will be eligible for testing.
By Nick Paul Taylor • July 3, 2019 -
FDA responds to feedback on De Novo classification requests
The agency disagreed with many of the changes suggested in public comments on a draft guidance explaining acceptance review policies and procedures.
By Susan Kelly • July 2, 2019 -
FDA finalizes rule on requesting review of CDRH decisions
The agency declined an AdvaMed request for additional time to seek supervisory review after a company receives details of a significant decision.
By David Lim • July 2, 2019 -
Ruptured Edwards balloons linked to 3 patient deaths
FDA revealed there have been 22 complaints related to rupture or puncture of an intra-aortic occlusion device, which can put patients at risk of complications like embolism, neurological damage and stroke.
By Nick Paul Taylor • July 2, 2019 -
Trump: US won't impose tariffs on $300B Chinese goods 'for the time being'
Existing 25% tariffs on $250 billion of Chinese goods, along with China's retaliatory tariffs, will remain in place.
By Shefali Kapadia • June 29, 2019 -
FDA language on breast density info sharing inadequate, some mammography stakeholders say
Memorial Sloan Kettering's breast imaging chief said a notification of higher risk may be "unduly alarming" to patients if providers aren't required to offer additional context and resources.
By Maria Rachal • June 28, 2019 -
Health Canada to mandate medical device adverse event reporting
The new regulations will force hospitals to report incidents within 30 days.
By David Lim • June 27, 2019 -
Jacob Bell/MedTech Dive
FDA finalizes guidance on diagnostic ultrasound systems
The text hews closely to the draft the agency issued in 2017, the core of which detailed its policy on 510(k) filings.
By Nick Paul Taylor • June 27, 2019 -
Jejunostomy tube manufacturer draws FDA warning letter
The agency reported a Colorado company had violations in the sterilization process for devices used for bowel decompression and lacked necessary procedures for evaluating its suppliers and inspecting finished products.
By Susan Kelly • June 26, 2019 -
Deep Dive
Looming EPA ethylene oxide rules hang over device supply chain
The medical device industry is lobbying Capitol Hill and statehouses, warning limited access to the sterilant could pose deadly disruptions.
By David Lim • June 25, 2019 -
Final TAVR Medicare decision gets thumbs up from Edwards, Medtronic
The new policy eases volume requirements for hospitals and physicians to begin transcatheter aortic valve replacement programs but increases the number of valve procedures necessary to maintain a program.
By Susan Kelly • June 24, 2019 -
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.
By David Lim • June 24, 2019 -
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.
By David Lim • June 21, 2019 -
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.
By Nick Paul Taylor • June 21, 2019 -
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.
By David Lim • June 20, 2019 -
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.
By Nick Paul Taylor • June 20, 2019 -
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.
By Nick Paul Taylor • June 20, 2019 -
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.
By Susan Kelly • June 19, 2019 -
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.
By Nick Paul Taylor • June 19, 2019 -
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.
By David Lim , Maria Rachal • Updated June 18, 2019 -
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.
By Nick Paul Taylor • June 18, 2019 -
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.
By Susan Kelly • June 17, 2019 -
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.
By Nick Paul Taylor • June 14, 2019
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