The Latest
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Deep Dive4 main takeaways from HIMSS19
Digest the biggest health IT conference of the year with this roundup of what grabbed the attention of more than 43,000 health execs, policymakers and academics.
Medical Devices -
SponsoredA medtech exec, pharma exec and venture capitalist walk onto a stage and talk digital health
Industry leaders are excited about the future of what digital can do for patients and our healthcare system.
Digital Health -
FDA proposes new channel for giving feedback on inspections
The agency is looking to create a process for providing nonbinding feedback to medical device companies that it expects to help speed corrective actions on safety and quality issues.
Medical Devices -
HIMSS19: Doctors don't know what to do with data from wearables
"If you present this data and bring in your device and say 'here I have this heart rate data from the last month' we're going to say, 'that's great, but we don't know what it really means,'" a Mayo Clinic medical director said.
Medical Devices -
Medtronic recalls pacemakers due to software error
The medtech giant is recalling 13,440 of the devices in the United States because the defect could result in a break in pacing function.
Medical Devices -
FDA clarifies pathway for devices used in regenerative medicine
The final guidance document covers instruments, machines and implants used in conjunction with cell-based and gene therapies.
Medical Devices -
Boston Scientific-BTG deal faces FTC holdup
The embolization beads businesses are at the heart of U.S. anti-trust regulators' concerns.
Medical Devices -
Deep DiveCMS eases study parameters in depression device coverage decision
LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.
UPDATED: Feb. 19, 2019 at 9:58 a.m.
Medical Devices -
FDA orders doctor to stop marketing unapproved breast augmentation device
The warning letter comes amid increased scrutiny of breast implants by regulators globally, with reported cases of adverse events linked to the devices on the rise.
Medical Devices -
New medtech initiatives to be funded amid 9% FDA budget boost
The agency would receive $269 million more in funding this year from the appropriations package that passed Congress, with allocations for initiatives addressing medtech manufacturing and digital health.
Medical Devices -
Tandem gets FDA OK for first interoperable insulin pump
The pump works with an array of automated insulin dosing systems, continuous glucose monitors and other products. FDA thinks the De Novo clearance will encourage marketing of more connected diabetes devices.
Medical Devices -
HIMSS19: Medical device cybersecurity still top concern
The WannaCry attack highlighted the need for hospitals to have a better understanding of medical devices in their inventory in order to better be equipped to respond to cyberattacks.
Medical Devices -
Headwinds stiffen as Quest revenues, earnings miss Q4 estimates
Elements of the fourth quarter financial results align with performance of chief rival LabCorp. Both companies are contending with Medicare rate reductions as a result of PAMA.
Diagnostics -
HHS pitches standard APIs, free patient access to health data in long-awaited rules
The twin proposed rules from CMS and ONC look to break down silos between health IT systems on the cusp of HIMSS, the biggest industry conference of the year.
Policy & Regulation -
FDA grants breakthrough status to amyloid beta Alzheimer's test
The assay analyzes the ratio of two forms of amyloid beta in cerebrospinal fluid to help determine if a patient has Alzheimer's.
Policy & Regulation -
Breast implants face increased safety scrutiny in Canada
Canada's health regulator is stepping up its review after a spike in reported cases of a form of cancer known as breast implant-associated anaplastic large cell lymphoma, a week after FDA flagged similar issues.
Medical Devices -
Software products face high-risk upclassing in Australia
The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.
Medical Devices -
J&J makes $3.4B robotic surgery buy
Johnson & Johnson gets the added boost of Auris Health's CEO and co-founder Frederic Moll joining its team, who notably co-founded market-leading Intuitive Surgical.
UPDATED: Feb. 14, 2019 at 10:05 a.m.
Medical Devices -
Medical devices recalled from US jump in Q4
The more than 400% surge in recalled units was underpinned by a widespread action by BD.
Medical Devices -
FDA panel backs vaginal mesh option, wants more data
The agency will consider recommendations from the obstetrics and gynecology devices panel as it makes decisions on premarket approval applications from Boston Scientific and Coloplast.
UPDATED: Feb. 14, 2019 at 10:52 a.m.
Medical Devices -
HIMSS19: Digital health 'at peak investment cycle,' expert says
Last year's record level of investment into United States digital health companies came despite a lull in initial public offerings.
M&A -
HIMSS19: Verma touts Blue Button 2.0 apps, though uptake still low
Only a few thousand Medicare beneficiaries have elected to share their claims data with production developers, the CMS administrator said.
Policy & Regulation -
Edwards Lifesciences buys maker of brain oxygen monitor
The device maker agreed to pay about $100 million for CAS Medical Systems to bolster its position in smart monitoring technologies.
Medical Devices -
GenomeDx pays $2M to settle genetic test false claims allegations
The U.S. government accused the company of billing Medicare for unnecessary prostate cancer tests.
Legal -
Industry strikes back at GAO's 'flawed and dangerous' PAMA report
AdvaMedDx and the other trade groups want to meet with the watchdog to discuss the dispute over the contention the payment law would cost Medicare billions rather than save.
Policy & Regulation