House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices

By a 392-28 vote, the House of Representatives passed its version of the legislation, which would renew the Food and Drug Administration's ability to collect user fees for the next five years.

By Elise Reuter • June 9, 2022

Medtronic: No new patient injury, death reports since April letters warning of HVAD defect

The company’s HeartWare Ventricular Assist Device System received a Class I label from the FDA following two patient injuries and one death.

By Ricky Zipp • Updated June 14, 2022

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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

GE Healthcare ventilator battery recall tied to over 1,500 complaints

Ventilators risk shutting down prematurely — cutting the flow of oxygen to patients — as backup batteries may run out of power earlier than expected.

By Nick Paul Taylor • Updated June 28, 2022

FDA mulls pilot program on alternative sterilization for medical devices

The proposed initiative is a response to global supply chain constraints and is intended to support sterilization supply chain resiliency, the agency said. 

By Nick Paul Taylor • June 8, 2022

Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans

Kevin Sayer spoke about the company's back-and-forth with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor and on a report that Dexcom was in talks to buy Insulet.

By Ricky Zipp • June 7, 2022

DHS warns cybersecurity vulnerabilities in Illumina software could affect test results

Three of the flaws outlined by the Department of Homeland Security received the highest risk score. Vulnerabilities could allow attackers to remotely alter the results generated by Illumina products.

By Nick Paul Taylor • June 6, 2022

Getinge's recall of 69,000 stents labeled as Class I event by FDA amid complaints, injuries

The recall relates to the separation of the balloon or catheter hub during the removal of the delivery system from the patient.

By Nick Paul Taylor • June 3, 2022

FDA to start accepting all pre-submissions for in vitro diagnostics

The agency had previously declined pre-submission requests unless they were related to COVID-19. Test developers should expect an extended timeline for reviews amid a backlog of pandemic-related submissions. 

By Elise Reuter • June 1, 2022

Medtronic expects diabetes unit's struggles to continue as rivals grow sales, launch products

The company forecasts revenues for the diabetes business to decrease 8% to 10% in the first quarter of its fiscal year and 6% to 7% for the full year.

By Ricky Zipp • June 1, 2022

BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years

The company said there are no known public exploits that specifically target a password vulnerability and that it's working to address the problem.

By Nick Paul Taylor • June 1, 2022

Recalled devices surged in first quarter, driven by BD connectors

A recall of 288 million Becton Dickinson connectors for catheter ports drove up the total number of recalled devices in the quarter. Mislabeling was the top reason for FDA alerts over the three-month period, a Sedgwick report found.

By Nick Paul Taylor • June 1, 2022

Abbott's Libre 3 glucose monitor gets FDA clearance as CGM market intensifies

The 14-day glucose sensor is smaller and thinner than its predecessor, and will give Abbott a head start on rival Dexcom’s newest continuous glucose monitor. 

By Nick Paul Taylor • May 31, 2022

Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks

The proximal markers in the Dragonfly OpStar Imaging Catheters can become loose and separate from the device while in use.

By Nick Paul Taylor • May 27, 2022

Proposed LDT regulations has diagnostics industry, consumer groups at odds

Consumer advocates say the proposed legislation has too many exemptions and doesn’t provide adequate protections for patients, while industry groups seek to limit premarket review requirements of legacy tests.

By Elise Reuter • May 25, 2022

Appeals court sides with Intuitive over J&J in surgical device patent disputes

A successful appeal by Ethicon would have affected imports of Intuitive Surgical’s SureForm staplers and associated reload cartridges.

By Nick Paul Taylor • May 24, 2022

Senate seeks to reform diagnostic oversight via user-fee bill, sparking mixed response

The revised bill from the Senate features a modified version of the Verifying Accurate Leading-edge IVCT Development Act that split the diagnostic industry when lawmakers previously tried to pass it.

By Nick Paul Taylor • May 23, 2022

FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown

The medical device reports were made between April 2021 and April 2022. Both Philips and the FDA contend that the reporting system has limitations, including the underreporting of events and inaccuracies of reports.

By Ricky Zipp • May 20, 2022

Google hires former FDA digital health officer to global strategy post

In his new role, Bakul Patel will help Google build a unified digital health and regulatory strategy.

By Samantha Liss • May 19, 2022

FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

By Elise Reuter • May 19, 2022

LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19

The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.

By Nick Paul Taylor • May 18, 2022

Avanos Medical recall gets Class I label from FDA following patient injury, death reports

The company reported in a recall notice that there have been 60 injuries and 23 patient deaths associated with the Avanos Medical Cortrak 2 Enteral Access System since 2015, according to the FDA.

By Ricky Zipp • May 17, 2022

FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.

By Nick Paul Taylor • May 16, 2022

Dexcom, Insulet, Tandem start 2022 with revenue growth after weathering omicron surge

All three diabetes technology companies reported that omicron pressured business in January before easing as the quarter progressed.

By Ricky Zipp • May 13, 2022

FDA needs testing enforcement discretion policy to improve crisis response, GAO finds

The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.

By Nick Paul Taylor • May 13, 2022

Hospital labor expenses up 37% from pre-pandemic levels in March

Medtech companies including Edwards Lifesciences and Zimmer Biomet expect pressure from hospital staffing shortages to continue through 2022. They're also monitoring if tightening finances will affect system placements. 

By Hailey Mensik • May 12, 2022