Policy & Regulation
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"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
Limited resources constrain federal oversight of medical device ads, GAO finds
U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.
By Nick Paul Taylor • Sept. 21, 2023 -
Carl Court via Getty Images
EU antitrust officials make surprise inspections at cardiovascular device company
The unnamed company may have violated EU rules against abusing a dominant market position, the European Commission said.
By Susan Kelly • Sept. 20, 2023 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
Stefan Zaklin via Getty Images
CMS leader defends breakthrough device reimbursement proposal at House hearing
Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.
By Nick Paul Taylor • Sept. 20, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA makes device conformity testing scheme permanent to streamline assessments
The FDA has delivered on a MDUFA V commitment by turning ASCA into a permanent, voluntary accreditation program.
By Nick Paul Taylor • Sept. 20, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA releases draft guidance for studying weight loss devices
The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.
By Nick Paul Taylor • Sept. 19, 2023 -
artJazz via Getty Images
MedTech Europe says MDR, IVDR framework needs ‘structural reform’
Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.
By Susan Kelly • Sept. 18, 2023 -
Sara Silbiger via Getty Images
FDA finalizes breakthrough device changes to target health inequities
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
By Nick Paul Taylor • Sept. 18, 2023 -
Lakshmiprasad S via Getty Images
Beacon Biosignals receives FDA clearance for sleep tracking headband
The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.
By Nick Paul Taylor • Sept. 18, 2023 -
Permission granted by Abbott Laboratories
Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA
The company contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode.
By Nick Paul Taylor • Sept. 14, 2023 -
Sarah Silbiger via Getty Images
FDA finalizes biocompatibility guidance for devices that touch the skin
The agency chose not to make some major requested revisions, such as including metals in the scope of the guidance.
By Nick Paul Taylor • Sept. 14, 2023 -
Stock via Getty Images
FDA finalizes combination product guidance 7 years after sharing draft
AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”
By Nick Paul Taylor • Sept. 13, 2023 -
Sarah Silbiger via Getty Images
TB deaths prompt FDA warning on reducing transmission risk
The agency outlined risk mitigation strategies for cell and tissue products after two recipients of bone matrix products died.
By Nick Paul Taylor • Sept. 13, 2023 -
iStock via Getty Images
CMS digs deeper into impact of proposed breakthrough device pathway in JAMA paper
The article discusses what the TCET pathway will mean for products at different stages of the life cycle.
By Nick Paul Taylor • Sept. 12, 2023 -
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 -
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
