FDA: Page 37
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Courtesy of Bose
Senators press FDA to finalize OTC hearing aids, accuse industry of 'astroturf' campaigns
The two cross-aisle politicians said they want to “expand access, reduce costs, and ensure a robust new market for safe and effective OTC hearing aids” and accused the device manufacturing lobby of “harming American consumers.”
By Elise Reuter • July 6, 2022 -
Sarah Silbiger via Getty Images
American Contract Systems' COVID-19 test recall gets Class I label from FDA
Off-site assembly by workers who may not have been properly trained prompted the company to recall COVID-19 tests amid concerns they may yield false results.
By Nick Paul Taylor • Updated July 6, 2022 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Permission granted by Apple
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 -
Retrieved from LiveMetric website on July 01, 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 -
Retrieved from Siemsens Website on July 01, 2022
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 -
Courtesy of Philips
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 -
Pablo Blazquez Dominguez via Getty Images
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 -
N/A via Getty Images
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 -
Permission granted by Becton Dickinson
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 -
Getty Images
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 -
Drew Angerer/Getty Images via Getty Images
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 -
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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 -
Sarah Silbiger via Getty Images
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 -
Megan Quinn/MedTech Dive
Deep DiveAs 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 Parduhn • June 22, 2022 -
Carl Court via Getty Images
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 -
Stefan Zaklin via Getty Images
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 -
Permission granted by Apple
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 -
Sarah Silbiger via Getty Images
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 -
Getty Images
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 -
Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Permission granted by Dexcom
Q&ADexcom 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
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