Medical Devices: Page 151
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GE recalls infant warmers due to panel, latch cracks
Two newborns reportedly fell from the beds and sustained skull fractures. The company is recalling 25,204 devices after receiving 338 complaints.
By Susan Kelly • Updated July 16, 2019 -
Ventilator software error prompts Hamilton Medical recall
FDA designated the recall as Class I because use of the device without a software correction may cause serious injury or death.
By Susan Kelly • July 15, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Philips, DHS flag cyber vulnerability in EKG analysis software
Highly skilled, unauthorized users may be able to enable system options not purchased in Philips' Holter 2010 Plus software, but the company said the issue shouldn't compromise patient data or overall system operations.
By Maria Rachal • July 15, 2019 -
Q&A
BSI 'overwhelmed' with work ahead of EU MDR, but bullish on market, exec says
The notified body's SVP of medical devices told MedTech Dive smaller manufacturers are particularly affected by the lack of capacity in the EU and are struggling to get existing certificates renewed before 2020.
By Dana Elfin • July 15, 2019 -
Jacob Bell/MedTech Dive
Pediatric device approval numbers are slowly rising, but not necessarily for young kids
In a report to Congress posted this week, FDA said device approvals with pediatric indications hit a decade-high in fiscal year 2017, despite only covering about a quarter of all granted PMAs and humanitarian device exemptions.
By Maria Rachal • July 12, 2019 -
Australia seeks ban on Allergan textured breast implants, J&J and others on thin ice
Following a lab assessment and statistical analysis, device makers have until July 24 to respond before regulators potentially ban the manufacture and distribution of several models.
By Maria Rachal • July 12, 2019 -
CMS outlines home infusion therapy benefit in proposed rule
Home infusion therapy allows for the delivery of certain drugs, such as anti-infectives, chemotherapy or treatment for immune deficiencies, with the use of a durable medical equipment pump at a patient's home.
By David Lim • July 12, 2019 -
FDA qualifies tool for nonclinical testing of ultrasound devices
The tool features a material designed to mimic the behavior of tissue to enable companies to assess and improve the safety of devices.
By Nick Paul Taylor • July 12, 2019 -
PMA approval rate has jumped since FDA changed panel meetings
The agency's likelihood of granting approval to PMA applications reviewed by an advisory committee rose from 70% to 92% after FDA changed in 2010 to a system where panelists vote anonymously on multiple questions.
By Nick Paul Taylor • July 12, 2019 -
Abbott Alinity blood plasma screening system gets FDA nod
The machine is designed to increase efficiency at diagnostic screening laboratories, run more tests in less space, more quickly generate test results and minimize human error.
By Dana Elfin • July 11, 2019 -
Mandatory bundled radiation oncology demo seeks to upend payment
Manufacturers with the most exposure include Varian Medical Systems, Accuray, Elekta and Siemens, according to Cowen.
By David Lim • July 11, 2019 -
Baxter to expand home dialysis on heels of Trump kidney initiative
Amid a push to move away from costly dialysis centers, Baxter said it expects to add and bolster facilities for making and distributing peritoneal dialysis solutions, devices and cassettes.
By Maria Rachal • July 11, 2019 -
FDA finalizes IDE broadcasting guidance, with concessions to industry
The final text is a major rewrite of a 2014 draft, which was criticized by AdvaMed.
By Nick Paul Taylor • July 11, 2019 -
FDA hits Clinicon with warning letter over sterility failings
Inspectors found fault with the validation and calibration of processes and equipment involved in ensuring sterility of laser devices.
By Nick Paul Taylor • July 11, 2019 -
Hill-Rom to sell surgical consumables unit for $170M
The transaction will free Hill-Rom of a stagnant business and its 500 employees, while giving it more cash to spend on acquisitions.
By Nick Paul Taylor • July 11, 2019 -
Trump executive order seeks to overhaul US kidney care
The plan aims, in part, to increase the number of organs available for transplant by encouraging the development of artificial and wearable kidneys and modernizing the organ recovery and transplantation system.
By Rebecca Pifer • Updated July 10, 2019 -
USTR exempts some medical devices from 25% China tariffs
More decisions on pending requests for exemption will be made on a periodic basis, according to the U.S. Trade Representative.
By David Lim • July 10, 2019 -
Yujin Kim/MedTech Dive
Amazon's momentum in medical supply chain slowing, poll finds
A UBS survey of hospital purchasing managers found providers are allocating purchases of surgical tools, orthopaedic and cardiology implants, and other medical supplies to Amazon at a lower rate this year compared to 2018.
By Rebecca Pifer • July 10, 2019 -
Edwards poised for a Q2 TAVR rebound, analysts predict
Jefferies tracked hospital purchasing data and found U.S. transcatheter aortic valve replacement procedures with Edwards' devices likely accelerated in the second quarter, despite Boston Scientific adding new competition to the mix.
By Susan Kelly • July 10, 2019 -
Hospital purchasers call 3D mammography, robots and TAVR investment priorities
UBS estimates stable growth of 3.6% in hospital capital budgets based on data collected from managers surveyed.
By David Lim • July 9, 2019 -
The 10 biggest medtech stories of Q2
Key storylines — like escalating tariffs between the U.S. and China, FDA's evolving position on paclitaxel devices, and the uncertain capacity of Europe's notified bodies — will unfold in the second half of the year.
By Maria Rachal • July 9, 2019 -
Medtronic HVAD shows low stroke risk in study of thoracotomy approach
The clinical data could help Medtronic reverse market share losses to Abbott, which makes a competing left ventricular assist device for patients suffering from advanced heart failure.
By Susan Kelly • July 9, 2019 -
Feds warn of cyber vulnerability in hospital anesthesia machines
The issue, found in GE's Aestiva and Aespire devices, could allow an attacker to impair respirator functionality by silencing alarms, altering time and date records, and changing the composition of aspirated gases.
By Susan Kelly • July 9, 2019 -
UnitedHealth backs Inspire Medical's sleep apnea implant
The massive private payer deemed the Minnesota medtech's neurostimulation system medically necessary in patients with obstructive sleep apnea who have already tried CPAP therapy.
By Maria Rachal • July 9, 2019 -
UL to close UK medical device notified body operation
The notified body is stepping back from the U.K. device sector altogether and will limit its in vitro diagnostic services in response to the risk of a no-deal Brexit.
By Nick Paul Taylor • July 9, 2019
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