FDA: Page 47
-
Amid pandemic, medtech R&D, merger activity jumped: EY report
Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.
By Nick Paul Taylor • Sept. 27, 2021 -
Justin Sullivan via Getty Images
Medtechs face supply chain disruptions from semiconductor shortage: report
The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.
By Nick Paul Taylor • Sept. 24, 2021 -
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions
The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.
By Nick Paul Taylor • Sept. 24, 2021 -
Getty Images
FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event
The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.
By Nick Paul Taylor • Sept. 23, 2021 -
EU threatens Illumina for closing $8B Grail deal while still under review
The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.
By Nick Paul Taylor • Sept. 22, 2021 -
Sarah Silbiger via Getty Images
Paige's AI-based software gets FDA nod to help doctors identify prostate cancer
It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.
By Nick Paul Taylor • Sept. 22, 2021 -
Medtronic embolization device hit with another Class I recall, 2 deaths cited
The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.
By Susan Kelly • Updated Sept. 22, 2021 -
Getty Images
Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market
The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority.
By Nick Paul Taylor • Sept. 21, 2021 -
UK seeks overhaul of AI, software as a medical device regs
The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.
By Greg Slabodkin • Sept. 20, 2021 -
Sarah Silbiger via Getty Images
FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study
The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.
By Nick Paul Taylor • Sept. 17, 2021 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
FTC warns app makers fall under breach notification rule
The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.
By Shannon Muchmore • Sept. 16, 2021 -
Getty Images
FDA creates new office to drive forward digital transformation strategy
Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.
By Nick Paul Taylor • Sept. 16, 2021 -
Alex Wong via Getty Images
CMS moves to scrap MCIT rule due to clinical evidence concerns
AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation.
By Nick Paul Taylor • Sept. 14, 2021 -
Deep Dive
Medtechs are boosting DTC investment, but industry still years behind pharma
Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.
By Ricky Zipp • Sept. 14, 2021 -
MedTech Europe calls for urgent clarification of EU artificial intelligence proposal
The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.
By Nick Paul Taylor • Sept. 13, 2021 -
Drew Angerer via Getty Images
Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push
Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.
By Greg Slabodkin • Sept. 10, 2021 -
Sarah Silbiger via Getty Images
FDA ends summer with fresh batch of breakthrough device designations
Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.
By Nick Paul Taylor • Sept. 10, 2021 -
Getty Images
Spine devices, recalls and endovascular stents on FDA's fall meeting lineup
Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning.
By Nick Paul Taylor • Sept. 8, 2021 -
Permission granted by Texas A&M University
Feds sue UPMC heart surgeon for billing multiple surgeries at same time
The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.
By Ron Shinkman • Sept. 7, 2021 -
Sarah Silbiger via Getty Images
TransMedics wins FDA nod for donor heart preservation system
Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.
By Susan Kelly • Sept. 7, 2021 -
EU expert panel starts accepting applications to review high-risk IVDs
The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.
By Nick Paul Taylor • Sept. 7, 2021 -
Permission granted by ECRI
Q&AECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb
Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.
By Ricky Zipp • Sept. 3, 2021 -
Medicare insolvency still expected by 2026, unchanged by COVID-19, trustees say
The forecast is a bit of a bright spot for the otherwise grim financial prospects of the program, as experts worried COVID-19 would result in the fund that finances Medicare Part A running out of money faster than previously expected.
By Rebecca Pifer Parduhn • Sept. 3, 2021 -
Courtesy of Eli Lilly
FDA restarts distribution of Lilly's COVID-19 drug in 22 states
Use of the treatment had been halted due to weakened efficacy versus an early coronavirus variant. Now, with delta widely prevalent and demand for antibody treatments surging, Lilly's therapy will be available again.
By Shoshana Dubnow • Aug. 31, 2021 -
Getty Images
Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms
Marion Gruber and Phil Krause, veteran vaccine reviewers, are unexpectedly departing at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.
By Ben Fidler • Updated Aug. 31, 2021
Previous
