FDA: Page 16
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Courtesy of U.S. Food and Drug Administration
FDA proposes 3 guidances to improve 510(k) clearance process
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
By Nick Paul Taylor • Sept. 7, 2023 -
Courtesy of Boston Scientific
Boston Scientific gets FDA nod for latest device in fast-growing Watchman franchise
Analysts at RBC Capital Markets called the Watchman FLX Pro approval an “incremental positive” for Boston Scientific.
By Nick Paul Taylor • Sept. 7, 2023 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
Courtesy of 23andMe
23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants
The new version of the test can report more cancer-related gene mutations, and 23andMe can add variants in the future under an agreement with the FDA.
By Nick Paul Taylor • Sept. 5, 2023 -
SHansche via Getty Images
UK regulators name 3 approved bodies to ease device certification bottleneck
A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”
By Nick Paul Taylor • Aug. 31, 2023 -
Courtesy of Hamilton Medical
Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA
The company contacted customers in June after learning that long-term use of the devices could cause them to stop providing active ventilation.
By Nick Paul Taylor • Aug. 31, 2023 -
iStock via Getty Images
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway
The groups want changes that include expanding the program to cover breakthrough diagnostics and previously authorized products.
By Nick Paul Taylor • Aug. 30, 2023 -
Courtesy of Withings
Withings wins FDA clearance for scale with AFib detection
The device records the electrical signal from the heart, assesses the number of calories the body burns at rest and tracks other health variables.
By Nick Paul Taylor • Aug. 30, 2023 -
Photo by Anna Tarazevich from Pexels
Hopes dim for Medtronic hypertension treatment after FDA panel rebuff
Analysts foresee hurdles to reimbursement even if the device wins the agency’s nod, and some don’t expect approval at all.
By Susan Kelly • Aug. 29, 2023 -
Justin Sullivan/Getty Images via Getty Images
US signs consent decree requiring EPA to finalize ethylene oxide rule by March
A medtech trade group called the deadline inadequate for the EPA to complete the “substantial” work that remains.
By Nick Paul Taylor • Aug. 28, 2023 -
Permission granted by Medtronic
Medtronic renal denervation device hits setback at FDA panel
The agency’s outside advisers found the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote.
By Susan Kelly • Aug. 24, 2023 -
Courtesy of Draeger
Draeger’s ventilator sound insulation recall triggers FDA Class I notification
The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.
By Nick Paul Taylor • Aug. 24, 2023 -
Courtesy of Recor
Recor wins FDA panel’s backing for high blood pressure device
The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the treatment.
By Susan Kelly • Aug. 23, 2023 -
Courtesy of Levita Magnetics
Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance
The device maker says the technology can reduce the need for an additional assistant in the operating room, driving efficiency.
By Nick Paul Taylor • Aug. 23, 2023 -
Retrieved from GE HealthCare via Business Wire.
GE HealthCare wins FDA clearance for wireless hospital vital sign monitor
The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.
By Nick Paul Taylor • Aug. 16, 2023 -
qingwa via Getty Images
Illumina faces SEC probe over Grail acquisition
The securities regulator has asked for documents tied to the 2021 deal in addition to the conduct and compensation of members of Illumina and Grail management.
By Susan Kelly • Aug. 14, 2023 -
iStock via Getty Images
Median lag between FDA authorization and Medicare coverage hits 6 years: study
Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.
By Nick Paul Taylor • Aug. 11, 2023 -
Courtesy of Getinge
Getinge’s heart assist pump shutdown problem given FDA Class I recall tag
The company notified healthcare providers after receiving 26 complaints about Cardiosave devices, used to support severely ill patients, unexpectedly shutting down.
By Nick Paul Taylor • Aug. 11, 2023 -
Permission granted by ZimVie
ZimVie wins FDA approval for smaller Mobi-C cervical disc
The device maker said the new product will “address the anatomical needs of the U.S. patient population.”
By Nick Paul Taylor • Aug. 10, 2023 -
Courtesy of Abbott Laboratories
Abbott lands FDA clearance of Alinity complete blood count system
The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.
By Nick Paul Taylor • Aug. 8, 2023 -
Permission granted by Medtronic
Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts
Needham analysts predict the experts will vote in favor of Medtronic and put the device on track to target a $1 billion-plus market.
By Nick Paul Taylor • Aug. 7, 2023 -
libre de droit via Getty Images
Penumbra says stroke device delayed at least 12 months due to FDA request
The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.
By Nick Paul Taylor • Aug. 4, 2023 -
Courtesy of Outset Medical
Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook
The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.
By Nick Paul Taylor • Aug. 4, 2023 -
Courtesy of Abbott
CMS inpatient final rule will have muted impact on medtech companies, analysts say
The CMS disclosed add-on payments that will continue in 2024 and named products that received approval under the breakthrough devices pathway.
By Nick Paul Taylor • Aug. 3, 2023 -
RiverNorthPhotography via Getty Images
Cooper scraps $875M takeover of Cook Medical business after FTC investigation
The FTC said ending the planned acquisition “ensures that critical reproductive health markets remain competitive.”
By Nick Paul Taylor • Aug. 2, 2023 -
Permission granted by Vicarious Surgical
Vicarious expects to perform first human procedure with robot next year
The company, after disclosing layoffs in February, said it has gained clarity on its regulatory pathway following pre-submission meetings with the FDA.
By Susan Kelly • July 31, 2023
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