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Home » Topics » Medical devices and technologies » Medical devices

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Eye illustration

Eluminex raises $40M series B for biosynthetic cornea, ophthalmology pipeline

Feb. 28, 2023
By Tamra Sami
Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen.
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MDR numbers for Philips respirators continue to track upward

Nov. 28, 2022
By Mark McCarty
The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.
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Group photo outside of the White House

CHIPS and Science Act signed into US law, but impact on semiconductor supply chain uncertain

Aug. 10, 2022
By Mark McCarty
President Joseph Biden signed into law the CHIPS and Science Act of 2022, a bill that calls for investment of $280 billion overall into the development and manufacturing of semiconductor products and which should ease the crunch on these products for medical device manufacturers. However, some have estimated that bringing new production capacity online can take three to five years, suggesting that the med-tech industry will need to continue to devise workarounds to the current supply crunch for the immediate future.
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Medicare outpatient draft rich with pass-through opportunities, but 340B drug tweak delayed

July 19, 2022
By Mark McCarty
The U.S. CMS released the draft Medicare hospital outpatient rule for calendar year 2023, a document that is replete with information on pass-through payment data for drugs and devices. However, the agency said that the Supreme Court’s ruling regarding rates for drugs covered under the 340B drug pricing program came too late in the annual cycle to be fully accounted for in the outpatient rule for 2023, and thus any such permanent adjustments will have to wait until the outpatient rule for 2024.
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Microchip robotic manufacturing concept

Semiconductor shortage continues to plague med-tech industry

May 6, 2022
By Mark McCarty
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
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
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
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.
Read More
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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