The Latest
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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.
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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.
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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.
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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.
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CRT wheelchair protection passes House Energy & Commerce Committee
The bill would permanently exclude manual complex rehab technology wheelchairs from the CMS competitive bidding program, a move the industry argues is needed to preserve access to the specialized equipment.
UPDATED: July 18, 2019 at 10:13 a.m. -
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.
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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.
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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.
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Cardinal set to change CEO of struggling medical segment
The leadership change follows a trimmed profit outlook for the unit in May.
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Hospitals may boost outsourcing of lab services: UBS poll
LabCorp may benefit most from the increasing use of service providers, with nearly 10% more respondents expressing interest in working with the company over rival Quest Diagnostics.
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CMS proposes Medicare cover acupuncture for patients in approved studies
Medicare doesn't usually cover alternative medical procedures, but the government is looking for ways to reduce the nation's dependence on highly addictive opioids for chronic pain.
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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.
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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.
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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.
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Bayer MRI contrast agent gets nod for coronary artery disease
The approval of Gadavist for diagnosing coronary artery disease is the fourth indication for the gadolinium-based contrast agent and gives Bayer the first approval for use of the agent in cardiac magnetic resonance imaging.
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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.
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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.
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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.
UPDATED: July 16, 2019 at 10:24 a.m. -
Screenings fail to explain rise in colorectal cancer in younger adults, study finds
The American Cancer Society called for further study of the trend, saying factors beyond expanded use of colonoscopy testing may play a role in driving the increased incidence of colorectal cancer.
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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.
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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.
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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.
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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.
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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.
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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.
