FDA: Page 93
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As shutdown stalls IPOs, companies mull creative paths to market
Biotechs in the process of going public are considering legal workarounds to bypass a hamstrung SEC, but the Nasdaq appears to be proceeding warily.
By Andrew Dunn • Jan. 18, 2019 -
FDA flags mortality risk of paclitaxel with stents, balloons for PAD
The letter to physicians follows a study identifying increased risk of death for patients two years after treatment for peripheral artery disease with a drug-coated balloon or drug-eluting stent.
By Susan Kelly • Jan. 18, 2019 -
Explore the Trendline➔
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 -
FDA finalizes guidance on development of antimicrobial tests
The document is intended to improve coordination between drug and diagnostic developers.
By Nick Paul Taylor • Jan. 18, 2019 -
Top House Democrat to focus on diagnostics revamp, drug prices in 2019
With Democrats now in power, the new chair of a key oversight subcommittee laid out her priorities, including proposals she argues will bolster the Affordable Care Act.
By David Lim • Jan. 17, 2019 -
No one solution to patient matching challenge, GAO says
Questions about the accuracy of digital matching tools force providers to recheck results manually, according to the government watchdog.
By Meg Bryant • Jan. 16, 2019 -
Senate Democrats question Gottlieb on FDA shutdown impact
FDA Commissioner Scott Gottlieb wrote Tuesday on Twitter the agency has returned 100 inspection staff to work to oversee high-risk medical device facilities.
By David Lim • Updated Jan. 16, 2019 -
Uncertainties abound with growing prospect of hard Brexit
The future for medtech companies in Europe was further complicated Tuesday with Britain's government firmly rejecting PM Theresa May's EU exit deal by a vote of 432 to 202, prompting debate of a no-confidence vote Wednesday.
By Meg Bryant • Updated Jan. 16, 2019 -
Brian Tucker/MedTech Dive
5 medtech trends to watch in 2019
FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.
By David Lim • Jan. 11, 2019 -
Empatica gets FDA clearance for epilepsy monitor in children
The device analyzes motion and physiological signals to detect when the wearer is having a seizure.
By Nick Paul Taylor • Jan. 11, 2019 -
FDA denies citizen petition calling for electroconvulsive therapy ban
The agency dismissed claims that the devices pose an unreasonable risk of injury.
By Nick Paul Taylor • Jan. 10, 2019 -
Grassley to zoom in on drug pricing, insurance mergers as Senate panel chair
The new Republican chairman of the Senate Finance Committee laid out his agenda for the year ahead.
By David Lim • Jan. 10, 2019 -
UK updates no-deal Brexit advice as vote on withdrawal agreement nears
Companies will need a designated individual based in the U.K. to register medical devices in the country.
By Nick Paul Taylor • Jan. 10, 2019 -
Medicare joint replacement program could succeed in more regions, Health Affairs study says
The mandatory bundled payment model first implemented in 2016 has shown some ability to cut spending without negatively affecting care quality.
By Les Masterson • Jan. 9, 2019 -
JPM19: FDA warns it won't be long before user fee funding runs dry
With no end in sight to the government shutdown, Commissioner Scott Gottlieb said medical device user fee programs have about two to three months of funding left.
By Jacob Bell • Jan. 9, 2019 -
LabCorp and Quest prepare for year of M&A as price cuts hit small labs
The laboratory testing giants expect reimbursement reductions to wipe out profits at smaller rivals, triggering a period of heavy consolidation.
By Nick Paul Taylor • Jan. 9, 2019 -
Health Affairs study calls for Medicare coverage of hearing care services
Research found that lower-income people with a hearing aid are twice as likely to experience trouble hearing compared to those with a higher income.
By David Lim • Jan. 8, 2019 -
FDA targets De Novo path to shepherd medical software through Pre-Cert
One industry lawyer questioned if the agency's most recent iteration will limit the program's potential by relying on the De Novo pathway, historically used rarely compared to its 510(k) program.
By David Lim • Jan. 8, 2019 -
CMS issues new DME strategy for patients dually-eligible for Medicare, Medicaid
The change is intended to eliminate a barrier to accessing durable medical equipment.
By Nick Paul Taylor • Jan. 8, 2019 -
Hospitals see 'modest' 3% savings using Medicare joint replacement model, study finds
Those participating didn't see a significant difference in complications or percentage of procedures among high-risk patients, according to the report in the New England Journal of Medicine.
By Les Masterson • Jan. 4, 2019 -
5 scariest health data breaches of 2018
They weren't all the biggest, but each shed light on how the industry isn't improving quickly on the cybersecurity front.
By Tony Abraham • Jan. 4, 2019 -
Booz Allen gives FDA device center progress high marks
Agency staff said better access to information about prior regulatory decisions of similar devices and more structured electronic submissions from manufacturers would help improve review efficiency.
By David Lim • Jan. 4, 2019 -
OIG finds Pacific Medical received unallowable Medicare payments
The oversight body wants the provider of orthotic braces to refund almost $250,000.
By Nick Paul Taylor • Jan. 4, 2019 -
HL7 releases latest FHIR version
The new iteration brings normative status, meaning future changes will be backward compatible.
By Meg Bryant • Jan. 3, 2019 -
Deep Dive
What's in a connected medical device? Cybersecurity regulators want to know
FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.
By Meg Bryant • Jan. 3, 2019 -
HHS issues voluntary guidelines amid rise of cyberattacks
The department, together with an industry-led task force, compiled best practices on how to protect patients and health systems from growing cyberthreats.
By Samantha Liss • Jan. 2, 2019
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