FDA: Page 76
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Wright Medical rocked by distributor disinterest and staff losses
"We will be bringing more knife fighters to the knife fight and having more motivated knife fighters in the knife fight," CEO Robert Palmisano said of a rivalry over sales reps.
By Nick Paul Taylor • Aug. 8, 2019 -
Jacob Bell
FDA grants breakthrough status to Perfuze stroke device
The startup is attempting to enter a field fought over by Johnson & Johnson, Medtronic and Stryker.
By Nick Paul Taylor • Aug. 8, 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 -
FDA to update paclitaxel device labels with mortality signal warning
The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.
By David Lim • Updated Aug. 8, 2019 -
iCubate lung infection test secures FDA breakthrough status
The in vitro diagnostics maker said it can accelerate diagnosis and treatment of a disease that affects more than 80,000 people in the U.S.
By Nick Paul Taylor • Aug. 7, 2019 -
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US to slap 10% tariffs on $300B in Chinese goods as medtech seeks details
The tariffs are set to take effect on Sept. 1. AdvaMed said it "strongly opposes tariffs by both sides on medical technology products" and is lobbying U.S. trade negotiators.
By Shefali Kapadia • Aug. 2, 2019 -
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 -
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 -
Jacob Bell
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 -
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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 -
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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 / BioPharma 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 -
Jacob Bell
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 / BioPharma 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 -
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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 -
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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
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