Policy & Regulation
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Deep Dive4 main takeaways from HIMSS19
Digest the biggest health IT conference of the year with this roundup of what grabbed the attention of more than 43,000 health execs, policymakers and academics.
By David Lim , Rebecca Pifer • Feb. 15, 2019
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HIMSS19: Medical device cybersecurity still top concern
The WannaCry attack highlighted the need for hospitals to have a better understanding of medical devices in their inventory in order to better be equipped to respond to cyberattacks.
By David Lim • Feb. 15, 2019
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New medtech initiatives to be funded amid 9% FDA budget boost
The agency would receive $269 million more in funding this year from the appropriations package that passed Congress, with allocations for initiatives addressing medtech manufacturing and digital health.
By Maria Rachal • Feb. 15, 2019
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Tandem gets FDA OK for first interoperable insulin pump
The pump works with an array of automated insulin dosing systems, continuous glucose monitors and other products. FDA thinks the De Novo clearance will encourage marketing of more connected diabetes devices.
By Nick Paul Taylor • Feb. 15, 2019
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FDA grants breakthrough status to amyloid beta Alzheimer's test
The assay analyzes the ratio of two forms of amyloid beta in cerebrospinal fluid to help determine if a patient has Alzheimer's.
By Nick Paul Taylor • Feb. 15, 2019
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Medical devices recalled from US jump in Q4
The more than 400% surge in recalled units was underpinned by a widespread action by BD.
By Nick Paul Taylor • Feb. 14, 2019
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Software products face high-risk upclassing in Australia
The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.
By Nick Paul Taylor • Feb. 14, 2019
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Industry strikes back at GAO's 'flawed and dangerous' PAMA report
AdvaMedDx and the other trade groups want to meet with the watchdog to discuss the dispute over the contention the payment law would cost Medicare billions rather than save.
By Nick Paul Taylor • Feb. 13, 2019
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Breast implants face increased safety scrutiny in Canada
Canada's health regulator is stepping up its review after a spike in reported cases of a form of cancer known as breast implant-associated anaplastic large cell lymphoma, a week after FDA flagged similar issues.
By Susan Kelly • Feb. 13, 2019
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FDA panel backs vaginal mesh option, wants more data
The agency will consider recommendations from the obstetrics and gynecology devices panel as it makes decisions on premarket approval applications from Boston Scientific and Coloplast.
By Maria Rachal • UPDATED: Feb. 14, 2019 at 10:52 a.m.
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HIMSS19: Verma touts Blue Button 2.0 apps, though uptake still low
Only a few thousand Medicare beneficiaries have elected to share their claims data with production developers, the CMS administrator said.
By David Lim • Feb. 13, 2019
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FDA approves Orthofix's cervical disc device
The implant will compete with products including Medtronic's Prestige LP and Zimmer Biomet's Mobi-C.
By Nick Paul Taylor • Feb. 12, 2019
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HHS pitches standard APIs, free patient access to health data in long-awaited rules
The twin proposed rules from CMS and ONC look to break down silos between health IT systems on the cusp of HIMSS, the biggest industry conference of the year.
By Rebecca Pifer • Feb. 11, 2019
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FDA finalizes guidance to strengthen its recall processes
The agency's move to improve its recall protocol across all categories follows a 2017 report from the Office of Inspector General of HHS that was particularly critical of FDA's food recall process.
By Susan Kelly • Feb. 11, 2019
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FDA to exempt handful of devices from 510(k) requirements
The latest deregulatory step does not exempt the products from other mandates such as registration and listing, labeling, good manufacturing practices and medical device reporting requirements.
By David Lim • Feb. 08, 2019
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India seeks to lure medtech to growing market
Only about 400 of the roughly 5,000 medical devices marketed in India are currently regulated.
By Meg Bryant • UPDATED: Feb. 12, 2019 at 10:16 a.m.
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Boston Scientific, Coloplast transvaginal meshes in spotlight at FDA panel
Expert advisors are meeting Tuesday to weigh the risks and benefits of the controversial devices. The agency moved them into the high-risk Class III category in 2016 after thousands of adverse events were reported.
By Maria Rachal • UPDATED: Feb. 11, 2019 at 10:21 a.m.
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Breast implant-associated lymphoma tied to at least nine US deaths, FDA says
The agency reported at least 457 unique cases of a form of non-Hodgkin lymphoma potentially linked to the device. The updated data comes weeks before a March advisory panel meets to examine known breast implant risks.
By Maria Rachal • Feb. 07, 2019
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FDA categorizes Edwards' cardiac diagnostic recall as Class I event
Edwards pulled the catheters from the market after learning that an assembly error was causing the devices to display inaccurate information.
By Nick Paul Taylor • Feb. 07, 2019
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FDA draft lays out submission paths for combo products
Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.
By David Lim • Feb. 06, 2019
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Cognoa's autism devices win breakthrough status
The special FDA designation covers the company's digital devices designed to improve the diagnosis and treatment of autism.
By Nick Paul Taylor • Feb. 06, 2019
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Current Health's wearable vital sign monitor gets FDA nod
The 510(k) clearance covers an arm-worn device that monitors variables such as oxygen saturation and alerts healthcare professionals to deviations.
By Nick Paul Taylor • Feb. 06, 2019
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Trump light on trade details in State of the Union address
The President's comments on trade were short and direct, calling for passage of the United States-Mexico-Canada Agreement (USMCA) and the lesser-known Reciprocal Trade Act.
By Emma Cosgrove • Feb. 05, 2019
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Deep DiveCMS eases study parameters in depression device coverage decision
LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.
By Maria Rachal • UPDATED: Feb. 19, 2019 at 9:58 a.m.
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FDA warns cardiologists of high mortality in Abiomed post-approval study
The 17% survival rate in the post-approval study of its Impella temporary right heart pump system prompted FDA to write to healthcare professionals and wiped 6% of Abiomed's stock.
By Nick Paul Taylor • Feb. 05, 2019