AliveCor ECG patent ruling sets stage for block on Apple Watch imports

Apple Watch imports to the U.S. could be barred if ruling by International Trade Court judge is finalized; Judge says Apple Watch infringes two cardiogram patents.

By Nick Paul Taylor • July 5, 2022

LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance

The wristwatch-like device will be made available through health systems, insurers and self-insured employers to ease continuous monitoring of blood pressure and avoid white-coat syndrome.

By Nick Paul Taylor • July 1, 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

Intuitive secures FDA clearance for lung biopsy robot featuring Siemens' imaging tech

The FDA clearance is an “incremental positive” for Intuitive, wrote analysts at RBC Capital Markets, adding that they see Ion as “an important leg of growth for the company.”

By Nick Paul Taylor • July 1, 2022

As Philips works to replace or repair recalled devices, supply problems are slowing it down

Logistical challenges mean patients won’t know when they will get a replacement sleep apnea or ventilator device until “at best a few weeks before it is delivered,” Philips executives said.

By Ricky Zipp • June 30, 2022

Commercial labs to ramp up monkeypox testing in 'coming weeks'

The Food and Drug Administration said in a Wednesday meeting that public health labs currently have a throughput of 10,000 tests per week, and the addition of five reference labs will expand that capacity to 60,000 tests per week.

By Elise Reuter • June 29, 2022

Sleep apnea devices show 'very low' amount of degraded foam, Philips says

Philips found evidence of foam breaking down in about 2% of 60,847 returned first generation DreamStation devices. The company said the problem was more prevalent in devices that used an ozone cleaning method. 

By Ricky Zipp • June 28, 2022

BD recalls emergency vascular access devices over risk of delayed care

Because patients who need intraosseous access are often critically ill, Becton Dickinson warned delays to care caused by the device problems could lead to death.

By Nick Paul Taylor • June 27, 2022

UnitedHealth's Optum looks to cut down on unnecessary lab testing

Optum says roughly 13 billion clinical lab tests are performed each year and 30% are unnecessary.

By Samantha Liss • June 27, 2022

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

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