FDA finalizes guidance for accepting De Novo requests

In the guidance, the agency explains procedures and criteria for assessing whether a device manufacturer's De Novo classification request should be accepted for a substantive review.

By Susan Kelly • Sept. 9, 2019

FDA finalizes guidance on HDEs after AdvaMed scrutiny

Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.

By Susan Kelly • Sept. 6, 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 floats idea for assessing the risk-benefit profile of weight-loss devices

Concerned that some patients lack access to effective weight-loss devices, the agency is seeking feedback to inform guidance that it says will help device developers offer a wider variety of tools.

By Nick Paul Taylor • Sept. 6, 2019

More Blue Cross plans now covering Senseonics' implantable glucose monitor

The medtech recently snagged a new positive coverage decision from Health Care Services Corporation, the nation's fourth largest insurer, which operates Blue Cross Blue Shield plans covering 16 million members across five states.

By Nick Paul Taylor • Updated Oct. 15, 2019

Prescient gets FDA breakthrough status for colorectal cancer test

If eventually approved, the test's competition includes Exact Sciences' Cologuard and an older test for blood in fecal samples.

By Nick Paul Taylor • Sept. 5, 2019

FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel

The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.

By David Lim • Sept. 3, 2019

Regulators put out call for experts to join device advisory committees

FDA is seeking people to sit on 18 panels that review medical device data and manufacturing regulations.

By Nick Paul Taylor • Sept. 2, 2019

FDA urges providers, manufacturers to transition to duodenoscopes with disposable parts

Boston Scientific told investors last year single-use duodenoscopes represent a market opportunity of more than $1 billion dollars.

By David Lim • Aug. 30, 2019

Summer slowdown drags on for De Novos

The FDA has not announced a De Novo clearance in 12 weeks. Two-thirds of the way through 2019, pacing suggests the overall number of novel device approvals won't match 2018's high.

By Maria Rachal • Aug. 30, 2019

McKesson, Philips devices flagged by DHS for cyber vulnerabilities

Certain cardiovascular IT systems and ultrasound devices could be exploited by hackers, the Department of Homeland Security wrote in separate notices.

By Nick Paul Taylor • Aug. 30, 2019

AdvaMed wins some, loses some in FDA guidance on managing uncertainty

While the agency tweaked parts of the document in line with feedback from AdvaMed and other groups, it maintained its plan to hold advisory committee meetings on certain postmarket data and kept other contested proposals.

By Nick Paul Taylor • Aug. 30, 2019

Medline, Vantage ethylene oxide emissions caused cancer, lawsuits claim

Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.

By David Lim • Aug. 29, 2019

AtriCure gets expanded FDA label for atrial exclusion device

AtriCure said it has strong growth from the AtriClip FLEX.V device and is confident growth rates for appendage management products will continue.

By Nick Paul Taylor • Aug. 28, 2019

FDA approves pediatric spine device via humanitarian pathway

The device is a less invasive alternative to spinal fusion for adolescents with idiopathic scoliosis.

By Nick Paul Taylor • Aug. 28, 2019

Titan Medical delays 510(k) submission until 2020 amid cash burn concerns

The company plans to use the delay to spread out its spending while working to implement the robotic surgery system's sterile instrument interface components, software improvements and training tools.

By David Lim • Aug. 27, 2019

Pharmacogenetic test makers cheer UnitedHealth coverage. Other payers aren't there yet.

"I've been concerned that the hype around pharmacogenetics, at least for depression, has gotten out ahead of the data," James Potash, director of psychiatry at the Johns Hopkins University, said.

By Graison Dangor • Aug. 27, 2019

Medicare contractors back use of Inspire's sleep apnea device

Inspire Medical has now received draft decisions from four different Medicare contractors for the sleep apnea therapy, which could eliminate reimbursement "fatigue factors" the company says are limiting use of the product.

By Nick Paul Taylor • Updated Sept. 3, 2019

Lawmakers to update VALID this fall, but industry still clashing over details

With Republican Sen. Richard Burr as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development Act in the coming months, multiple sources familiar with the issue told MedTech Dive.

By David Lim • Aug. 26, 2019

Big data, cybersecurity among top FDA device center priorities

Reprocessing of devices and biocompatibility are also addressed in a report intended to incorporate new tech into regulatory decisions.

By David Lim • Aug. 23, 2019

Medicare draft decisions may boost Natera, Myriad tests

Cowen analysts called proposed local coverage for Natera's colorectal cancer test as "materially broader and quicker than expected," while documents on pharmacogenomic tests gave a mixed outlook for Myriad Genetics' products.

By Nick Paul Taylor • Aug. 23, 2019

Industry sounds alarm on EU single-use device reprocessing regs

There remains a risk that the European Commission will miss its November target and fail to finalize the draft policy before MDR comes into force. 

By Nick Paul Taylor • Updated Aug. 27, 2019

ONC in talks with Congress, White House on third-party health app privacy

National Coordinator for Health Information Technology Don Rucker said there is bipartisan interest in taking action.

By Rebecca Pifer • Aug. 21, 2019

AdvaMed warns White House sterilization regs pose device shortage risk

The trade association's chief lobbyist told administration officials in a meeting an effective ban on ethylene oxide as a sterilant "poses an imminent public health threat through shortages of medical devices."

By David Lim • Aug. 21, 2019

FDA issues device sterilization warning letter

The notice accuses Innovative Sterilization Technologies of promoting the sterilization product in applications outside of the scope of its 510(k) clearance.

By Nick Paul Taylor • Aug. 21, 2019

FDA approves MRI labeling for Boston Scientific DBS system

CEO Michael Mahoney touted the growth of the company's deep brain stimulation products to investors during its second quarter earnings call.

By David Lim • Aug. 20, 2019