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Home » Topics » Medical devices and technologies » Medical devices

Medical devices
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Royal Philips headquarters

Philips raises awareness of implantable electronic device infections

March 7, 2022
By Annette Boyle
Royal Philips NV expanded its commitment to increasing awareness of cardiovascular implantable electronic device (CEID) infections with a new partnership with the American Heart Association (AHA). The organizations are rolling out a program to educate medical professionals on the proper management of these infections which are commonly treated with antibiotics, an approach that leads to reinfection in the majority of cases.
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Aortic aneurysm illustration

US FDA eyes real-world surveillance for devices indicated for repair of AAAs

Feb. 28, 2022
By Mark McCarty
There are several devices on the market to repair the dreaded abdominal aortic aneurysm (AAA), but these carry some serious risks that have prompted multiple FDA advisories. The agency’s latest announcement recommends routine clinical follow-up for these patients for life, and the formation of a “real-world surveillance system” that may require the financial and technical assistance of industry and medical societies to develop.
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Stepped arrow

US FDA says first-cycle PMA major deficiency rates spiked in CY 2021

Feb. 28, 2022
By Mark McCarty
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade.
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Lauxera group photo

Lauxera sets up largest fund in Europe for medical technology

Feb. 23, 2022
By Bernard Banga
PARIS – One year after inception, Lauxera Capital Partners SAS reported final closing of its Lauxera Growth I fund at nearly $300 million, making it the leading European fund devoted to financing health-tech businesses. Lauxera Capital’s objectives involve supporting fast-growing European firms and ramping their international business development.
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FDA sign

Quick approval of ’UFAs needed to secure US FDA funding

Feb. 3, 2022
By Mari Serebrov
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.
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Gavel and stacks of coins

Australia’s TGA to increase industry fees to retain its cost recovery model

Feb. 1, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
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U.S. flag, New York City

Med-tech industry sees persistent hazards in ongoing CPU shortage

Jan. 27, 2022
By Mark McCarty
The semiconductor industry has been hit hard by shortages of computer central processing units (CPUs) in recent months, but the persistence of these shortages has prompted a new response from industry. The Advanced Medical Technology Association (AdvaMed) said device makers are taking steps to ease the crunch, but that the Biden administration must take steps to ensure that medical technologies do not suffer from shortages, given the critical role played by devices in patient care.
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Gavel and stacks of coins

Australia’s TGA to increase industry fees to retain its cost recovery model

Jan. 27, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
Read More
EMA icons

New EU mandate strengthens EMA’s emergency preparedness role

Jan. 25, 2022
By Mari Serebrov
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.
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Adbry (tralokinumab)

Leo’s Adbry approved by FDA for atopic dermatitis

Dec. 28, 2021
By Lee Landenberger
Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
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