FDA: Page 101
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FDA sets 2019 medical device user fee rates
The agency said the base fee for a premarket application received during FY 2019 is $300,000 with the base fee for an establishment registration at $4,548.
By Susan Kelly • July 30, 2018 -
CMS advisers split on procedure volume rules for TAVR
Edwards LifeSciences and Medtronic offered different takes on the current coverage policy.
By Susan Kelly • July 30, 2018 -
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 -
CMS pitches covering cardiac catheterization at surgical centers
Jefferies analysts expect the agency will eventually add coverage for knee replacements at ambulatory surgical centers.
By Susan Kelly • July 30, 2018 -
CDHR extends staff training program into 2019
The Experiential Learning Program provides ongoing training for FDA staff about the device development cycle.
By Rebecca Pifer Parduhn • July 30, 2018 -
ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups
"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.
By David Lim • July 27, 2018 -
FDA gives draft guidance on atherectomy device submissions
The advice is intended to help manufacturers develop a risk analysis and performance testing strategy for devices used to remove plaque from diseased peripheral arteries.
By Susan Kelly • July 27, 2018 -
Pharma, medtech spending accounted for 28% of CME funds in 2017
This was the fourth consecutive yearly increase in medical education spending from industry.
By Rebecca Pifer Parduhn • July 26, 2018 -
Baxter boosts 2018 outlook but IV bag supply still under pressure
"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO ​José Almeida told investors.
By David Lim • July 26, 2018 -
Endomagnetics' Sentimag System scores approval from FDA
The system, which helps guide lymph node biopsies for breast cancer patients undergoing mastectomy, utilizes magnetic rather than radioactive materials.
By David Lim • July 25, 2018 -
House repeals medical device tax, Senate path muddied
The device industry has successfully put off the tax, one of several imposed on industry in the Affordable Care Act, for years.
By David Lim • Updated July 24, 2018 -
5 key parts of the FDA Medical Device Safety Action Plan
The ambitious proposal focuses on a total lifecycle approach to device safety.
By Meg Bryant • July 23, 2018 -
Deep Dive
Pharma and AI? Let's try augmented intelligence first
Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.
By Lisa LaMotta • July 23, 2018 -
Bayer to stop selling Essure birth control implant in US
The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.
By Susan Kelly • July 23, 2018 -
Maryland broadens hospital price transparency initiative
The Maryland Health Care Commission website helps consumers compare prices for common non-emergency procedures.
By Tony Abraham • July 20, 2018 -
Industry seeks clarity on latest FDA Pre-Cert working model
A software coalition questioned the agency's statutory authority to run a pilot test in 2019.
By David Lim • July 19, 2018 -
FDA finalizes guidance on use of EHRs in clinical trials
Industry groups including AdvaMed and BIO were broadly supportive of an earlier draft.
By Nick Paul Taylor • July 19, 2018 -
FDA reiterates concern about off-label use of bile-duct stents
In 2016, Abbott won a whistleblower lawsuit by a former sales representative who accused the company of off-label marketing of bile-duct stents to treat peripheral artery disease.
By Susan Kelly • July 18, 2018 -
Calls to revamp physician self-referral law grow louder
Device makers, lab, imaging and hospital companies all back changes to the Stark law, arguing it impedes the move toward alternative payment and value-based care.
By Susan Kelly • July 18, 2018 -
Jacob Bell/MedTech Dive
FDA approves Stryker flow diverter, creating competition for Medtronic
The device gives surgeons another way to treat unruptured intracranial aneurysms.
By Nick Paul Taylor • July 18, 2018 -
Device industry lobbies FDA on combo product classification
AdvaMed argues the agency too often concludes a product’s primary mode of action is that of a drug or biologic rather than a device.
By Susan Kelly • July 17, 2018 -
HHS kills clinical guidelines website, cites budget cuts
The National Guideline Clearinghouse, a 20-year-old archive of best medical practices, was shut down this week. On Tuesday, the nonprofit that maintained the site said it will keep a fee-based version to launch in the fall.
By Rebecca Pifer Parduhn • July 17, 2018 -
Quest study contends value-based care adoption has slowed
The survey found that 57% of health plan executives believe physicians do not have the necessary tools to succeed in a value-based system, up from 45% last year.
By David Lim • July 17, 2018 -
Abbott device to repair leaky heart valves approved
Artificial heart valve pioneer Edwards LifeSciences is developing treatments for mitral regurgitation that would compete with Abbott's MitraClip.
By Susan Kelly • July 16, 2018 -
CMS targets data gaps in setting lab payments
The American Clinical Laboratory Association said it "will urge Congress as well as CMS to address significant shortfalls in the data collection process that jeopardize care for the most vulnerable seniors."
By Susan Kelly • July 16, 2018 -
Deep Dive
Transition clock ticking on new EU device regs
"It's a problem because how do you comply with a new standard when you don't know what the standard is?" said AdvaMed's Joe Gatewood.
By Meg Bryant • July 16, 2018
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