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BioWorld - Tuesday, July 5, 2022
Home » Topics » Medical devices and technologies » Medical devices

Medical devices
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Microchip robotic manufacturing concept

Semiconductor shortage continues to plague med-tech industry

May 6, 2022
By Mark McCarty
No Comments
The shortage of semiconductor products, such as computer processors, was an artifact of the COVID-19 pandemic, but the shortage has yet to ease, to the detriment of hospitals, device makers and patients. That dilemma surfaced again as the U.S. Department of Commerce met with device makers to discuss the dilemma, which in the views of some still constitutes a crisis of health care.
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Biotech deal illustration

Seeing opportunity in autoinjectors, Halozyme to buy Antares for $960M

April 13, 2022
By Lee Landenberger
No Comments
Drug delivery opportunities are at the heart of Halozyme Therapeutics Inc.’s nearly $1 billion acquisition of Antares Pharma Inc. The deal brings Halozyme an autoinjector platform to complement its Enhanze drug delivery technology, which is designed to reduce hours-long treatments to minutes.
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Jeong Woo Cho, president and CEO, SK Biopharmaceuticals.

SK Biopharmaceuticals’ three-part epilepsy approach underway

March 29, 2022
By Gina Lee
No Comments
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
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Jeong Woo Cho, president and CEO, SK Biopharmaceuticals.

SK Biopharmaceuticals’ three-part epilepsy approach underway

March 25, 2022
By Gina Lee
No Comments
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
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Royal Philips headquarters

Philips raises awareness of implantable electronic device infections

March 7, 2022
By Annette Boyle
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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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