FDA: Page 78
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Japan to reimburse TransEnterix's robotic surgery system
The decision positions the company to compete with Intuitive Surgical in one of the largest markets for the platforms.
By Nick Paul Taylor • Aug. 2, 2019 -
UnitedHealthcare's depression test decision boosts Myriad's prospects
While Medicare only permits psychiatrists to order the test, the private payer will reimburse requests from all providers.
By Nick Paul Taylor • Aug. 2, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
FDA grants breakthrough status to Procyrion's cardiac device
Procyrion's Aortix aims to offer physicians a minimally invasive, lower-risk alternative to left ventricular assist devices when treating patients with acute decompensated heart failure and worsening renal function.
By Nick Paul Taylor • Aug. 1, 2019 -
FDA announces fiscal 2020 device user fee rates
The fees, which cover medical device registration, submissions and certain periodic reports, show slight increases from the 2019 rates.
By Susan Kelly • July 31, 2019 -
CMS pilot to give doctors patient Medicare claims data
CMS hopes to eventually roll out the initiative to all Medicare fee-for-service providers, giving doctors Medicare claims data for their patients, including prescribed medications, procedures, diagnoses and other providers.
By David Lim • July 30, 2019 -
CMS pitches add-on payment for new renal care tech, DME fee adjustments
The agency projects total payments to hospital-based ESRD facilities to rise 1.9% year to year while payments to freestanding renal care facilities like DaVita and Fresenius are set to increase 1.5%.
By David Lim , Maria Rachal • July 30, 2019 -
FDA clears Lyme disease tests, ending reliance on immunoblots
Zeus Scientific won the clearances after convincing the agency using enzyme immunoassays alone is as accurate as the current two-tiered approach.
By Nick Paul Taylor • July 30, 2019 -
Australia on watch for possible EU notified body shortage
The country's Therapeutic Goods Administration has issued new guidance to aid device makers seeking overseas marketing authorization.
By Susan Kelly • July 29, 2019 -
FDA finalizes biliary stent guide after Cook, Boston Scientific feedback
The final guidance hews closely to the draft released for consultation last year, despite Cook calling for a variety of changes.
By Nick Paul Taylor • July 26, 2019 -
Edwards discontinues Centera valve, goes all in on Sapien 3 TAVR line
Executives said the company anticipates FDA will approve the transcatheter aortic valve replacement product for patients with low surgical risk during the third quarter.
By David Lim • July 24, 2019 -
FDA directly links Allergan Biocell breast implants with cancer risk, prompting recall
"FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women's health," Principal Deputy Commissioner Amy Abernethy wrote Wednesday regarding Allergan's Biocell textured devices.
By Nick Paul Taylor • July 24, 2019 -
Titan Medical warns robotic surgery filing target may slip
The Canadian medtech called the regulatory filing schedule "very tight" and "not completely within [its] control."
By Nick Paul Taylor • July 24, 2019 -
Jacob Bell/MedTech Dive
FDA sets final guidance on combo product safety reporting
The agency aims to provide clarity on new recordkeeping rules as more medical products combining devices and drugs are hitting the market.
By Susan Kelly • July 23, 2019 -
Pear files insomnia and depression software as Pre-Cert pilot 510(k)
CEO Corey McCann told MedTech Dive he hopes the digital therapeutic will be cleared in the first half of 2020, but cautioned Pear has "a good deal of learning to do in terms of the FDA response to this specific submission."
By David Lim • July 19, 2019 -
Jacob Bell/MedTech Dive
Opinion
Medical device corrections, removals and recalls: Where are we now?
Companies must balance maintaining a credible relationship with FDA while resisting actions that may not ultimately be in the best interests of patient safety, write Hogan Lovells' Jodi Scott and Wil Henderson.
By Jodi Scott and Wil Henderson • July 19, 2019 -
Sterigenics strikes deal to reopen Willowbrook sterilization plant
The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • Updated Sept. 9, 2019 -
Teleflex recalls neonatal breathing devices amid gas leak risk
The company is pulling 300 of the devices from the U.S. market months after receiving FDA clearance to sell the product.
By Nick Paul Taylor • July 18, 2019 -
BD expedites fixes for faulty pumps after additional injuries
The manufacturer shared news of the hastened timeline days after the FDA categorized the recall of more than 600,000 devices as a Class I event.
By Nick Paul Taylor • July 18, 2019 -
FDA launches innovation challenge to boost ethylene oxide sterilization alternatives
The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization.
By David Lim • July 16, 2019 -
CMS proposes Medicare cover acupuncture for patients in approved studies
Medicare doesn't usually cover alternative medical procedures, but the government is looking for ways to reduce the nation's dependence on highly addictive opioids for chronic pain.
By Rebecca Pifer • July 16, 2019 -
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 -
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 -
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 -
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
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