FDA: Page 77
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CRT wheelchair protection passes House Energy & Commerce Committee
The bill would permanently exclude manual complex rehab technology wheelchairs from the CMS competitive bidding program, a move the industry argues is needed to preserve access to the specialized equipment.
By Susan Kelly • Updated July 18, 2019 -
Flickr / Brenden Ashton
Australia seeks ban on Allergan textured breast implants, J&J and others on thin ice
Following a lab assessment and statistical analysis, device makers have until July 24 to respond before regulators potentially ban the manufacture and distribution of several models.
By Maria Rachal • July 12, 2019 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
CMS outlines home infusion therapy benefit in proposed rule
Home infusion therapy allows for the delivery of certain drugs, such as anti-infectives, chemotherapy or treatment for immune deficiencies, with the use of a durable medical equipment pump at a patient's home.
By David Lim • July 12, 2019 -
Jacob Bell
FDA qualifies tool for nonclinical testing of ultrasound devices
The tool features a material designed to mimic the behavior of tissue to enable companies to assess and improve the safety of devices.
By Nick Paul Taylor • July 12, 2019 -
PMA approval rate has jumped since FDA changed panel meetings
The agency's likelihood of granting approval to PMA applications reviewed by an advisory committee rose from 70% to 92% after FDA changed in 2010 to a system where panelists vote anonymously on multiple questions.
By Nick Paul Taylor • July 12, 2019 -
Mandatory bundled radiation oncology demo seeks to upend payment
Manufacturers with the most exposure include Varian Medical Systems, Accuray, Elekta and Siemens, according to Cowen.
By David Lim • July 11, 2019 -
Baxter to expand home dialysis on heels of Trump kidney initiative
Amid a push to move away from costly dialysis centers, Baxter said it expects to add and bolster facilities for making and distributing peritoneal dialysis solutions, devices and cassettes.
By Maria Rachal • July 11, 2019 -
Adobe Stock
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 -
Jacob Bell
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 -
Getty Images
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 -
Jacob Bell
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 -
Getty Images
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 / BioPharma 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 -
Brian Tucker
Deep DiveLooming 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 -
Getty Images
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
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