Contract sterilizer of devices draws FDA warning over validation issues

American Contract Systems received multiple complaints about the presence of foreign matter in sealed sterilization bags, the agency said.

By Nick Paul Taylor • Dec. 4, 2019

FDA approves TB test from Qiagen and DiaSorin

The approval could be a win-win for both companies, bringing Qiagen's TB blood test to DiaSorin's ​Liaison immunoassay analyzers while expanding the testing menu for Liaison. 

By Nick Paul Taylor • Dec. 2, 2019

Explore the Trendline➔

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

With 6 months until new EU medical device rules, what's the state of play?

Preparing for the May 26, 2020, implementation of the EU's Medical Device Regulation hasn't been easy, given the lack of notified bodies designated to review devices under the more stringent standards.

By Dana Elfin • Updated Nov. 26, 2019

Mandatory CMS radiation oncology model goes on the backburner

Originally, the agency was eying an implementation date as early as Jan. 1, but the new regulatory agenda lists July 2022 as a target date for the bundled payment model. 

By David Lim • Nov. 26, 2019

FDA launches pilot to speed new ethylene oxide sterilization methods

Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.

By David Lim • Nov. 25, 2019

AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs

A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.

By David Lim • Nov. 22, 2019

Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV

The approval allows Medtronic to sell the paclitaxel-coated balloon as a treatment for failing arteriovenous access in dialysis patients.

By Nick Paul Taylor • Nov. 22, 2019

Rare medical device ban, OTC hearing aids make FDA year-end to-do list

Medical device manufacturers concerned about a federal crackdown on commercial ethylene oxide sterilizers can breathe a sigh of relief as the EPA says a timeline for final regulations remains to be determined.

By David Lim • Nov. 21, 2019

Transcatheter device to treat heart failure gets breakthrough designation

BioVentrix is enrolling 120 subjects in a clinical trial meant to support U.S. marketing authorization for its minimally invasive alternative to conventional surgical ventricular reconstruction.

By Nick Paul Taylor • Nov. 21, 2019

Trump FDA nominee Hahn advanced by Senate HELP Committee 18-5

Ranking Member Patty Murray said she would not support the nomination due to a lack of a commitment to back regulations to take non-tobacco flavored e-cigarettes that have not gone under FDA review off the market. 

By David Lim • Updated Dec. 3, 2019

Carolina Liquid gets FDA warning over sale of unauthorized reagents

FDA said Carolina Liquid distributed Class I and II IVD reagents without regulatory clearance. The warning is the latest in a series of letters issued this year to companies for distributing devices without premarket approval. 

By Nick Paul Taylor • Nov. 20, 2019

AdvaMed wants FDA to define 'significantly' improved for Safer Technologies Program eligibility

Although the trade association said it supports efforts to speed safer medical devices to market, it believes the agency's draft guidance lacks the specificity needed for industry to understand which devices would be eligible.

By David Lim • Nov. 19, 2019

FDA clears Pentax duodenoscope with disposable part in bid to cut infection risk

Center for Devices and Radiological Health Director Jeff Shuren called the clearance "another major step toward lowering the risk of infection among patients," and said duodenoscope safety is a top priority for the agency.

By David Lim • Nov. 18, 2019

Hospitals — and now insurers — to reveal secret rates under latest Trump admin pitch

Industry lobbies are sure to fight back against what would be a landmark shift in healthcare.

By Samantha Liss • Nov. 15, 2019

FDA advisers: Metal implants need beefed up ingredient labels

Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue. 

By Maria Rachal • Nov. 15, 2019

FDA overhauls export certificate guidance after negative feedback

AdvaMed said the draft suffered "from inaccuracies and omissions that FDA must correct." The final guidance provides more information on the appeals process and grounds for denials.

By Nick Paul Taylor • Nov. 14, 2019

Hologic wins FDA approval for AI-based breast imaging tech

The imaging company claims the platform saves radiologists one hour per eight hours of interpretation.

By Nick Paul Taylor • Nov. 14, 2019

FDA experts weigh evidence on patients' adverse reactions to common device metals

Suggestions from speakers at Wednesday's advisory panel included conducting comparative effectiveness studies, bolstering the informed consent process and requiring more stringent adverse event reporting.

By Maria Rachal • Nov. 13, 2019

Boston Scientific faces lower reimbursement despite White House lobbying bid

In an Office of Management and Budget meeting days before release of CMS' hospital outpatient payment final rule, execs argued the change would deter doctors from a procedure using a device that could reduce opioid dependence.

By David Lim • Nov. 13, 2019

Paige gets CE mark for prostate cancer detection technology

The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.

By Nick Paul Taylor • Nov. 13, 2019

Eudamed 2-year delay doesn't mean free pass for manufacturers

"The Eudamed project is expensive both in time and resources. It is not just an IT project, this is a change project," said Eudamed.eu CEO Richard Houlihan.

By Dana Elfin • Nov. 12, 2019

FDA grants breakthrough status to AI-based gastric cancer diagnostic

The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.

By Nick Paul Taylor • Nov. 12, 2019

Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says

The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.

By David Lim • Nov. 8, 2019

Medtronic reveals high-risk cyber vulnerability in electrosurgical generators

The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.

By Nick Paul Taylor • Nov. 8, 2019

Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure'

FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency and override state legislation to get sterilization plants back online, one advisory panel member said.

By David Lim • Nov. 8, 2019