CVS launches home hemodialysis device clinical trial

The drugstore giant, which now includes insurance heavyweight Aetna, argues it can help reduce the $35 billion in Medicare costs associated with the treatment of end-stage renal disease.

By David Lim • July 17, 2019

Cardinal set to change CEO of struggling medical segment

The leadership change follows a trimmed profit outlook for the unit in May.

By Nick Paul Taylor • July 17, 2019

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

FDA launches innovation challenge to boost ethylene oxide sterilization alternatives

The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization. 

By David Lim • July 16, 2019

Abbott's latest MitraClip version gains FDA approval

The company has the minimally invasive mitral repair sector to itself for now, but rivals including Edwards and Boston Scientific are eyeing the space.

By Susan Kelly • July 16, 2019

J&J pegs new robotic surgery platforms, cementless knees as device growth drivers

The finalized divestiture of the Advanced Sterilization Products business resulted in roughly $2 billion in pre-tax gain during the quarter, which Johnson & Johnson said was offset partly by R&D investment in Auris Health.

By Maria Rachal • July 16, 2019

Intuitive buys Schölly's robotic endoscope business

The deal will give the robotic surgery giant control of the German company's minimally invasive visualization systems, 200 staff and three sites.

By Nick Paul Taylor • July 16, 2019

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

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

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

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

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