Medical Devices
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Intuitive sees bump to Q2 leasing revenues
Rising da Vinci revenues helped drive the robotic surgery technologies maker to a $1.1 billion quarter, surpassing Wall Street expectations.
By Maria Rachal • July 19, 2019 -
Pear files insomnia and depression software as Pre-Cert pilot 510(k)
CEO Corey McCann told MedTech Dive he hopes the digital therapeutic will be cleared in the first half of 2020, but cautioned Pear has "a good deal of learning to do in terms of the FDA response to this specific submission."
By David Lim • July 19, 2019 -
OpinionMedical device corrections, removals and recalls: Where are we now?
Companies must balance maintaining a credible relationship with FDA while resisting actions that may not ultimately be in the best interests of patient safety, write Hogan Lovells' Jodi Scott and Wil Henderson.
By Jodi Scott and Wil Henderson • July 19, 2019 -
Breast reconstruction device manufacturer to file for bankruptcy
AirXpanders, which won a De Novo clearance for its carbon dioxide gas controlled tissue expander, is set to end customer and sales support Thursday and file a petition for relief under Chapter 7 by the end of next week.
By Maria Rachal • July 18, 2019 -
Sterigenics strikes deal to reopen Willowbrook sterilization plant
The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • July 18, 2019 -
Most hospitals don't meet watchdog group's safe volume thresholds for high-risk surgeries
The Leapfrog Group's analysis of eight high-risk procedures at more than 2,000 hospitals included mitral valve repair and replacement.
By Susan Kelly • July 18, 2019 -
Teleflex recalls neonatal breathing devices amid gas leak risk
The company is pulling 300 of the devices from the U.S. market months after receiving FDA clearance to sell the product.
By Nick Paul Taylor • July 18, 2019 -
BD expedites fixes for faulty pumps after additional injuries
The manufacturer shared news of the hastened timeline days after the FDA categorized the recall of more than 600,000 devices as a Class I event.
By Nick Paul Taylor • July 18, 2019 -
Abbott teases FreeStyle Libre potential beyond glucose monitoring
The company is expanding manufacturing of its blockbuster diabetes device, a technology CEO Miles White said could be expanded to track other analytes.
By Maria Rachal • July 17, 2019 -
FDA warns of risks when shunt implants, hearing devices mix
Because magnetic field interference between implanted shunts and hearing devices may cause unintended changes to valve settings, the agency advises magnet-containing devices be kept a certain distance away from shunt valves.
By Susan Kelly • July 17, 2019 -
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 -
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 at 10:24 a.m. -
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 -
Q&ABSI '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
