FDA: Page 31
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Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
The EU's Medical Device Regulation certification process is taking twice as long as the old directive pathway and smaller companies are struggling to get started, the poll shows.
By Nick Paul Taylor • July 18, 2022 -
Sarah Silbiger via Getty Images
FDA faces furloughs if Senate misses August deadline for user fee bill
If legislation isn’t passed before the August recess, the FDA would have to furlough workers, slowing its review of medical device and pharmaceutical products.
By Elise Reuter • July 15, 2022 -
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TrendlineMedical 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 -
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Medtronic warns European healthcare providers of safety problem in defibrillators
The warning adds to Medtronic’s growing list of product safety issues over the last 18 months.
By Ricky Zipp • July 15, 2022 -
Permission granted by Columbia University
Q&AFriday Q&A: Ian Lipkin, Columbia epidemiologist, talks COVID-19 testing as U.S. sees another wave
Lipkin explained why he’s not a fan of antigen tests, and stressed the need to keep PCR testing a core part of the pandemic response.
By Elise Reuter • July 15, 2022 -
Permission granted by DarioHealth
Lack of payment pathway clarity hinders digital therapeutics, analysts say
The report warns of a sector beset by payment issues, “snake oil” and “middling adoption.”
By Nick Paul Taylor • July 15, 2022 -
artJazz via Getty Images
EC publishes IVDR guidance in absence of completed Eudamed database
The commission recently announced a timeline for complete implementation of Eudamed, aiming for the second quarter of 2024.
By Ricky Zipp • July 13, 2022 -
Pablo Blazquez Dominguez via Getty Images
Quest launches monkeypox PCR test as U.S. attempts to catch up with rising cases
The company estimates it will be able to process 30,000 tests per week by the end of July. As of July 12, there were 929 confirmed cases in the U.S., the CDC reported.
By Ricky Zipp • July 13, 2022 -
Courtesy of Abbott
Abbott gets FDA breakthrough tag for deep brain stimulation system in depression
The breakthrough device designation builds on a series of clinical trials of other systems that have yielded mixed results.
By Nick Paul Taylor • July 13, 2022 -
Alex Wong via Getty Images
CMS makes 'market-moving proposals' to some medtech Medicare rates, say analysts
BTIG analysts warned in a recent report that the changes “might curtail usage of some higher-dollar” medical devices.
By Nick Paul Taylor • July 12, 2022 -
Carl Court via Getty Images
European Commission targets spring of 2024 for fully functional Eudamed database
The Commission is planning a two-phase transition to mandatory use of the database after it goes live.
By Nick Paul Taylor • July 11, 2022 -
Medtronic recalls over 1M dialysis catheters due to malfunction
The recall is the latest in a growing list of product safety issues for Medtronic, including Class I recalls and an FDA warning letter for its diabetes unit.
By Ricky Zipp • July 11, 2022 -
Chip Somodevilla via Getty Images
Ex-Mazor executive charged by SEC with insider trading over Medtronic's $1.6B buyout
Doron Tavlin, who was Mazor’s vice president of business development, is accused by the agency of profiting from his inside knowledge of the pending takeover.
By Nick Paul Taylor • July 11, 2022 -
Permission granted by iRhythm Technologies
CMS proposes national rates for cardiac monitoring; iRhythm's stock jumps
The proposed rule could end a years-long saga for the cardiac market, although pricing specifics may change in the final version.
By Ricky Zipp • July 8, 2022 -
Carl Court via Getty Images
High-risk IVD tests rules finalized by European Commission despite industry calls for change
MedTech Europe pushed back against some of the requirements, but the Commission has retained disputed parts of the document.
By Nick Paul Taylor • July 8, 2022 -
alvarez via Getty Images
Getinge recalls anesthesia machines due to cracked, broken suction power switches
The FDA labeled the recall a Class I event, marking Getinge’s fifth Class I recall since September.
By Ricky Zipp • July 7, 2022 -
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 -
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 -
Stock via 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
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