FDA: Page 81
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FDA finalizes IDE broadcasting guidance, with concessions to industry
The final text is a major rewrite of a 2014 draft, which was criticized by AdvaMed.
By Nick Paul Taylor • July 11, 2019 -
FDA hits Clinicon with warning letter over sterility failings
Inspectors found fault with the validation and calibration of processes and equipment involved in ensuring sterility of laser devices.
By Nick Paul Taylor • July 11, 2019 -
Explore the Trendlineâž”
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 -
USTR exempts some medical devices from 25% China tariffs
More decisions on pending requests for exemption will be made on a periodic basis, according to the U.S. Trade Representative.
By David Lim • July 10, 2019 -
The 10 biggest medtech stories of Q2
Key storylines — like escalating tariffs between the U.S. and China, FDA's evolving position on paclitaxel devices, and the uncertain capacity of Europe's notified bodies — will unfold in the second half of the year.
By Maria Rachal • July 9, 2019 -
UL to close UK medical device notified body operation
The notified body is stepping back from the U.K. device sector altogether and will limit its in vitro diagnostic services in response to the risk of a no-deal Brexit.
By Nick Paul Taylor • July 9, 2019 -
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 -
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The agency disagreed with many of the changes suggested in public comments on a draft guidance explaining acceptance review policies and procedures.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
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