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Low upfront costs fuel investor interest in health app startups, analysts say
A new report highlights low development costs as a factor that may encourage new entrants to stick with the sector despite changing regulations and concerns about data security.
By Nick Paul Taylor • March 7, 2019 -
Medicare panel gives equivocal backing to Novocure's brain cancer device
The panelists expressed some confidence that the Optune device improves outcomes but also raised concerns related to issues like patient compliance.
By Nick Paul Taylor • March 7, 2019 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
What does Gottlieb's resignation mean for medtech?
CDRH chief Jeff Shuren was a steady force as four different FDA commissioners cycled through the agency's top spot in 2019.
By David Lim , Maria Rachal • March 6, 2019 -
FDA proposes exempting some flow cytometers from 510(k) requirements
The change is intended to streamline the path to market for some devices that count or characterize cells.
By Nick Paul Taylor • March 6, 2019 -
Paying patients to shop MRIs results in some savings: Health Affairs
Price reductions were mostly seen in imaging services. During the first 12 months of the program, MRI prices fell by 4.7%, ultrasound by 2.5%, mammograms by 1.7% and CT scans by 1.4%.
By Meg Bryant • March 5, 2019 -
FDA Commissioner Scott Gottlieb to step down in a month
The exit comes as the agency revamps its medical device approval pathways.
By David Lim • Updated March 5, 2019 -
CVS to close retail audiology centers ahead of over-the-counter regulations
FDA has made clear it believes consumers should be able to take a more active role in managing hearing loss.
By David Lim • March 4, 2019 -
As robotic surgery booms, FDA cautions against use for cancer
Agency leaders cited lack of evidence on safety and effectiveness, but major health systems report using the tech for cancer patients.
By Maria Rachal • March 1, 2019 -
EU debuts drug-device Q&A ahead of regulatory changes
The guidance sets out how incoming medical device regulations will affect developers of pre-filled syringes and other combination products.
By Nick Paul Taylor • March 1, 2019 -
Gottlieb pledges device, drug reviews will be on time post shutdown
The FDA chief's appearance before Congress comes a day after a bill was introduced to allow the agency to accept new medical device applications and user fees during a government shutdown.
By David Lim • Feb. 28, 2019 -
Hologic gets EU clearance for breast lesion localization tag
The device uses radio frequency identification to wirelessly guide surgeons to breast lesions.
By Nick Paul Taylor • Feb. 28, 2019 -
UK updates Brexit medtech advice as cliff edge exit looms
The Medicines and Healthcare products Regulatory Agency document sheds new light on the responsible person requirement and parallel importing policy.
By Nick Paul Taylor • Feb. 28, 2019 -
Feds team up to speed diagnostic testing access in emergencies
Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.
By David Lim • Feb. 27, 2019 -
Prosthetics controlled by brain implants in the offing, FDA says
Such devices may sound like science fiction, but in conjunction with a draft guidance on the topic, Commissioner Scott Gottlieb called the possibility within reach.
By David Lim • Feb. 25, 2019 -
Biotronik's drug-eluting stent expands to US market with PMA
The Orsiro system for coronary artery disease will play against Abbott's Xience and Medtronic's Resolute.
By Maria Rachal • Feb. 25, 2019 -
Deep Dive
Neuromodulation market expands amid hunt for opioid alternatives
Stigma, cost and risk of surgery don't seem to be stopping growth of devices that target nerve activity central to diseases like Alzheimer's, epilepsy and chronic pain.
By Meg Bryant • Feb. 22, 2019 -
FDA rule on device study practices comes into force
The final rule mandates the use of good clinical practices by sponsors of trials based outside the U.S.
By Nick Paul Taylor • Feb. 22, 2019 -
Japan agrees to reimburse LivaNova's sutureless aortic heart valve
The insurance coverage decision should help the company grow sales of its Perceval device.
By Nick Paul Taylor • Feb. 22, 2019 -
Philips' camera-guided digital imaging system gets FDA OK
The nod comes after Philips reported fourth quarter growth in image-guided therapy, ultrasound and diagnostic imaging.
By Meg Bryant • Feb. 21, 2019 -
First commercial epilepsy patient gets Medtronic deep brain stimulation device
The device, which received premarket approval from FDA in April, aims to reduce how often patients experience partial-onset seizures by delivering electrical stimulation to certain areas in the brain.
By David Lim • Feb. 21, 2019 -
Swiss regulator weighs in on textured breast implants
Swissmedic is the latest national authority to flag a lymphoma that may be tied to breast implants.
By Susan Kelly • Feb. 20, 2019 -
ACLA, AdvaMedDx clash on lab test overhaul bill
The latest version of draft legislation incorporated suggestions from FDA, including a precertification program. The Pew Charitable Trusts cautioned that may open up patients to risk from unreviewed products.
By David Lim • Feb. 20, 2019 -
FDA grants breakthrough status to concussion-detecting VR headset
The SyncThink device analyzes the wearer's eye movements. The medtech has deals with the Golden State Warriors and hospitals including Mass General.
By Nick Paul Taylor • Feb. 20, 2019 -
Deep Dive
4 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.
By David Lim , Rebecca Pifer Parduhn • Feb. 15, 2019 -
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.
By David Lim • Feb. 15, 2019
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