Supreme Court overturns Roe v. Wade, ending constitutional right to abortion

26 states are certain or likely to end abortion rights, making abortion effectively illegal in half of the country, according to the Guttmacher Institute.

By Sydney Halleman • June 24, 2022

Baxter ventilator recall labeled Class I event by FDA after 2 deaths

Baxter initiated the recall after learning that an improper setup could reduce oxygen flow to in-home users, causing serious injury or death.

By Nick Paul Taylor • June 24, 2022

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

Patient death prompts another recall of Medtronic's HVAD System

The company initiated another recall for the troubled heart pump after a patient died when two batteries simultaneously stopped working, the company said, adding to a list of safety problems with the device.

By Ricky Zipp • June 23, 2022

FDA opens consultation on tissue removal devices to reduce cancer risk

The agency is seeking feedback on draft guidance to help manufacturers of tissue containment systems reduce risk that cancerous tissue could leak during procedures.

By Nick Paul Taylor • June 22, 2022

As cross-state telemedicine waivers expire, virtual care advocates focus on long-term policy changes

There’s a complication: No one solution to the U.S.’ patchy physician licensing infrastructure has universal buy-in.

By Rebecca Pifer • June 22, 2022

Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe

Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.

By Nick Paul Taylor • June 17, 2022

User fee package goes to Senate with lab-developed test, OTC hearing aid provisions

The Senate HELP committee passed its version of the FDA user fee bill by a 13-9 vote. It includes an overhaul of diagnostic testing regulations and a requirement to create a category of over-the-counter hearing aids.

By Elise Reuter • June 15, 2022

Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects.

By Nick Paul Taylor • June 14, 2022

Dräger's breathing system filter recall gets Class I label from FDA after ventilation obstruction

An obstruction in one of the company’s SafeStar 55 devices resulted in a patient being resuscitated after becoming hypoxic.

By Nick Paul Taylor • June 13, 2022

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

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